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138 Trials

   

Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Ervebo (recombinant vesicular stomatitis virus (VSV) expressing the envelope glycoprotein of Ebola Virus Zaire) / Merck (MSD)
NCT05992480: REVIVE (Response to the Ebola Virus Vaccine)

Not yet recruiting
4
40
RoW
rVSVDG-ZEBOV-GP Ebola Virus Vaccine (ERVEBO)
Tulane University, Kenema Government Hospital, Merck Sharp & Dohme LLC
Ebola Virus Disease
01/26
02/26
NCT06587503: Safety and Immunogenicity of rVSVΔG-ZEBOV-GP Vaccination When Dosed Concurrently With mRNA COVID-19 Vaccine Booster Doses

Not yet recruiting
4
72
NA
BioNTech - Pfizer COVID-19 vaccine, Cominarty, 1mL saline solution, rVSV∆G-ZEBOV-GP, Ervebo
University of Birmingham, Project San Francisco, Rwanda Biomedical Centre, Merck Sharp & Dohme LLC
Ebola Virus Disease, COVID-19
12/24
05/25
EBO-BOOST, NCT06126822: Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC

Recruiting
3
624
RoW
Zabdeno® booster, Ervebo® booster
Institute of Tropical Medicine, Belgium, Institut National pour la Recherche Biomedicale (INRB)
Ebola Virus Disease
10/26
10/26
EBO-PEP, NCT06841614: EBOla Post-Exposure Prophylaxis

Not yet recruiting
3
160
RoW
Ervebo, r-VSV-ZEBOV vaccine, Inmazeb, REGN-EB3
ANRS, Emerging Infectious Diseases, Alliance for International Medical Action, Centre de Recherche et de Formation en Infectiologie de Guinée (CERFIG), Medecins Sans Frontieres, Netherlands, Barcelona Institute for Global Health, University of Bordeaux, INSERM 1136, Agence Nationale de Sécurité Sanitaire de Guinée (ANSS), National Institute for Biomedical Research DRC, Cheikh Anta Diop University, Senegal, PACCI Program, The PANdemic preparedness plaTform for Health and Emerging infectious Response, University of Sierra Leone College of Medicine and Allied Health Sciences, National Public Health Institute of Liberia
Ebola Virus Disease
06/27
12/27
PREPARE, NCT05959421: Immunity Induced by VSV-EBOV and Assessment of a Booster Dose in Individuals at Potential Occupational Risk for Exposure

Not yet recruiting
3
70
Europe
ERVEBO® (rVSV∆G-ZEBOV-GP)
Universitätsklinikum Hamburg-Eppendorf, Bernhard Nocht Institute for Tropical Medicine, Goethe University, German Federal Ministry of Education and Research, Monipol Deutschland GmbH
Ebola Vaccine
12/27
06/28
PROVAE, NCT04822376: Prophylaxis Vaccine Antibodies Ebola

Not yet recruiting
2a
250
RoW
ansuvimab, mab114, Ervebo, VSV-ZEBOV
ANRS, Emerging Infectious Diseases
Ebola Virus Disease
04/22
04/22
NCT05202288: Pilot Study Evaluating the Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers

Not yet recruiting
2a
135
RoW
Ervebo, r-VSV-ZEBOV vaccine, Inmazeb, REGN-E3B
ANRS, Emerging Infectious Diseases, Alliance for International Medical Action, University of Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France, Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire, Agence Nationale de Sécurité Sanitaire de Guinée (ANSS), Clinical and Operational Research Alliance (CORAL), Méthodologie et Evaluation pour la Recherche clinique et Epidémiologique sur le VIH en Afrique (MEREVA)
Ebola Virus Disease
03/23
03/23
NCT02876328 / 2019-001308-39: Partnership for Research on Ebola VACcinations

Completed
2
4789
RoW
Ad26.ZEBOV, rHAd26, MVA-BN-Filo, MVA, MVA-mBN226B, rVSVΔG-ZEBOV-GP, rVSV, V920, Placebo, rVSV boost
National Institute of Allergy and Infectious Diseases (NIAID), Partnership for Research on Ebola Virus in Liberia (PREVAIL), Institut National de la Santé Et de la Recherche Médicale, France, London School of Hygiene and Tropical Medicine, European and Developing Countries Clinical Trials Partnership (EDCTP)
Ebola Virus Disease
12/19
12/23
NCT03031912 / 2016-004853-34: African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola

Active, not recruiting
2
250
Canada
V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine, Saline
Cecile Tremblay, Merck Sharp & Dohme LLC, International Development Research Centre, Canada, Dalhousie University, Université de Montréal, Coalition for Epidemic Preparedness Innovations
Ebola
10/24
02/25
NCT02788227: Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV[Delta]G-ZEBOV-GP) for Pre-Exposure Prophylaxis (PREP) in People at Potential Occupational Risk for Ebola Virus Exposure

Completed
2
99
US
rVSV-Zebov GP vaccine
National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteers
06/25
06/25
NCT06100913: Immunology of Ebola Vaccine

Recruiting
2
30
US
Recombinant Vesicular Stomatitis Vaccine for Ebola (rVSV∆G-ZEBOV-GP), Ervebo
Emory University, Washington University School of Medicine, Merck Sharp & Dohme LLC
Ebola Virus Disease
12/26
12/26
EBOLAPED, NCT05130398: Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Living in Lambaréné, Gabon

Completed
1/2
120
RoW
rVSVΔG-ZEBOV-GP, V920, Fibre and equilibrate breakfast and lunch, Active detection and treatment of pathogens, Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogens, Chikenpox or Varicella vaccine (VARILRIX), Placebo
Centre de Recherche Médicale de Lambaréné, Merck Sharp & Dohme LLC
Ebola Virus Disease
09/21
08/22
NCT02257840: Safety and Immunogenicity of Prime-Boost VSV Ebola Vaccine in Healthy Adults

Recruiting
1
120
US
Placebo, BPSC1001
National Institute of Allergy and Infectious Diseases (NIAID)
Ebola Viruses
10/15
10/15
EBOSURV, NCT05313139: Surveillance of Vaccine-induced Immunity Against Ebola in Previously Vaccinated Health Care Workers

Recruiting
N/A
245
RoW
Institute of Tropical Medicine, Belgium
Immune Response
08/22
12/22
VRC01 / Acuitas Therap
NCT02140255: Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

Recruiting
1/2
1120
US, RoW
Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Nevirapine (NVP), Lopinavir/Ritonavir (LPV/r), Raltegravir (RAL), VRC01, DTG, VRC07-523LS
National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
HIV Infection
01/28
12/31
NCT03729752: PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)

Recruiting
1
30
US
[89]Zr-DFO-VRC-HIVMAB060-00-AB, [89]Zr-DFO-VRC01
University of California, San Francisco, amfAR, The Foundation for AIDS Research
HIV-1-infection
10/26
12/26
NCT06006546: The Study of Immunization in People Living With HIV Undergoing an ATI for Elicitation of VRC01-lineage Antibodies

Recruiting
1
40
US
426c.Mod.Core-C4b, Adjuvant 3M-052-AF+Alum
National Institute of Allergy and Infectious Diseases (NIAID)
Chronic HIV Infection
12/25
12/25
NCT04860323: Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study

Completed
N/A
13
RoW
Analytical Treatment Interruption
HIV Vaccine Trials Network, National Institute of Allergy and Infectious Diseases (NIAID), HIV Prevention Trials Network, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Infection
02/25
02/25
NCT04801758: Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 704/HPTN 085 AMP Study

Completed
N/A
18
RoW
Analytical Treatment Interruption
HIV Vaccine Trials Network, National Institute of Allergy and Infectious Diseases (NIAID), HIV Prevention Trials Network, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Infection
07/24
07/24
ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
2004-001525-21: Estudio clínico controlado con placebo, aleatorizado, de fase II, para evaluar la inmunogenicidad y la toxicidad de dos patrones de inducción-refuerzo complementarios con el ALVAC-VIH vCP1452 en pacientes con infección crónica del VIH

Ongoing
2
20
Europe
ALVAC(2)HIV (vCP1452), ALVAC(2)120(B,MN)GNP (vCP1452),
ORVACS, Objectif Recherche Vaccin SIDA
Infección por el VIH
 
 
NCT01435135: Study of Late Boost Strategies for HIV-uninfected Participants From Protocol RV 144

Active, not recruiting
2
162
RoW
ALVAC-HIV, (vCP1521), AIDSVAX B/E, ALVAC-HIV Placebo, AIDSVAX B/E Placebo
U.S. Army Medical Research and Development Command, National Institutes of Health (NIH)
HIV Infections
07/21
07/21
NCT01931358: Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX® B/E

Active, not recruiting
2
360
RoW
ALVAC-HIV, AIDSVAX B/E, ALVAC-HIV Placebo, AIDSVAX B/E Placebo
U.S. Army Medical Research and Development Command, National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
12/21
12/21
polyTregs / National Institute of Allergy and Infectious Diseases
TASK, NCT02711826: Treg Therapy in Subclinical Inflammation in Kidney Transplantation

Completed
1/2
32
US
Polyclonal Regulatory T Cells, Polyclonal Tregs, polyTregs, Everolimus, Zortress, Tacrolimus, FK-506, FR-900506, Prograf, Mycophenolate mofetil, Cellcept, MMF, Mycophenolic acid, Myfortic, MPA, Acetaminophen, Tylenol, Diphenhydramine, Benadryl, Biopsy, Kidney, Kidney Biopsy, Blood Draw, Phlebotomy, Venipuncture, Leukapheresis, leukocytapheresis, IS regimen conversion, Everolimus Conversion
National Institute of Allergy and Infectious Diseases (NIAID), Clinical Trials in Organ Transplantation
Kidney Transplant, Adult Living Donor Kidney Transplant Recipients, Renal Transplant, Living Kidney Donor
08/23
08/23
NCT03239470: Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus

Terminated
1
5
US
Cohort 1: 1.0 x 10^8 PolyTregs, Polyclonal Regulatory T Cells, autologous PolyTregs, CD4+CD127lo/negCD25+ PolyTregs, Cohort 2: 2.5x10^8 PolyTregs
National Institute of Allergy and Infectious Diseases (NIAID), Autoimmunity Centers of Excellence, Rho Federal Systems Division, Inc.
Pemphigus Foliaceus, Pemphigus Vulgaris
12/20
01/23
NCT03444064: PolyTreg Immunotherapy in Islet Transplantation

Completed
1
11
Canada
PolyTregs, Ex vivo Expanded Autologous CD4+CD127lo/-CD25+ Polyclonal Regulatory T cells
University of Alberta, Diabetes Research Institute Foundation, Liana's Dream Foundation, Juvenile Diabetes Research Foundation, Alberta Diabetes Institute
Diabetes, Diabetes Mellitus, Type 1
08/24
12/24
cePolyTregs, NCT05349591: in Islet Transplantation

Withdrawn
1
11
Canada
cePolytreg
University of Alberta, Juvenile Diabetes Research Foundation, Juvenile Diabetes Research Foundation Canadian Clinical Trial Network
Diabetes type1
05/25
05/25
Vimkunya (Chikungunya Vaccine, Recombinant) / Bavarian Nordic
CHIKV VLP, NCT05072080 / 2023-001124-42: A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 ( Vaccine)

Completed
3
3258
US
CHIKV VLP/adjuvant, Placebo
Bavarian Nordic, Emergent BioSolutions
Chikungunya Virus
04/23
04/23
NCT05349617: Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years

Completed
3
413
US
CHIKV VLP/adjuvant, Placebo
Bavarian Nordic, Emergent BioSolutions
Chikungunya Virus
06/23
08/23
2023-001124-42: A Phase 3 Clinical Trial to evaluate PXVX0317, a virus-like particle vaccine for active immunization to prevent disease caused by chikungunya virus.

Not yet recruiting
3
3150
US
CHIKV VLP vaccine, PXVX0317, Suspension for injection
Bavarian Nordic A/S, Bavarian Nordic A/S
Healthy Volunteers (Chikungunya disease. Prevention of Chikungunya disease by use of a vaccine), Healthy Volunteers (Prevention of Chikungunya disease), Diseases [C] - Virus Diseases [C02]
 
 
2025-000141-10: A multi-country study to test the safety and effectiveness of a chikungunya virus vaccine in children aged 2 to 11. The study is designed so that neither the participants nor the researchers know who is getting the vaccine and who is getting a placebo (an inactive substance).

Not yet recruiting
3
720
RoW, US
CHIKV VLP, CHIKV VLP, Suspension for injection, VIMKUNYA
Bavarian Nordic A/S, Bavarian Nordic A/S
Healthy Volunteers (Chikungunya disease. Prevention of Chikungunya disease by use of a vaccine.), Healthy Volunteers (Prevention of Chikungunya disease), Diseases [C] - Virus Diseases [C02]
 
 
NCT06007183: Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination

Active, not recruiting
3
800
US
CHIKV VLP vaccine booster, PXVX0317, Placebo booster
Bavarian Nordic
Chikungunya Virus Infection
04/28
08/28
2015-003556-44: investigational Chikungunya virus (CHIKV) vaccine study to evaluate the safety and Immunogenicity of a Chikungunya Virus

Not yet recruiting
2
400
Europe
VRC-CHKVLP059-00-VP, VRC-CHKVLP059-00-VP, Solution for injection in pre-filled syringe
IMEA Fondation Leon Mba, FHI360
To evaluate the safety and tolerability of VRC-CHKVLP059-00-VP vaccin in healthy adults that reside in CHIKV endemic ., To evaluate the safety and tolerability of VRC-CHKVLP059-00-VP in healthy adults that reside in CHIKV endemic, Body processes [G] - Immune system processes [G12]
 
 
rabies Vaccine (ChAd155-RG) / National Institute of Allergy and Infectious Diseases
NCT04019444: Dosage-Escalation Study of the Safety and Immunogenicity of a Novel Rabies Vaccine ChAd155-RG vs. the Comparator RABAVERT Vaccine in Healthy Adult Subjects

Completed
1
50
US
ChAd155-RG, Placebo, Rabies Vaccine
National Institute of Allergy and Infectious Diseases (NIAID)
Rabies, Rabies Immunisation
03/23
03/23
SAR441236 / Sanofi
NCT03705169: Pharmacokinetics and Safety of SAR441236

Terminated
1
52
US
SAR441236, Placebo
National Institute of Allergy and Infectious Diseases (NIAID), Sanofi, ModeX Therapeutics
HIV-1-infection
04/22
04/22
VH3810109 / ViiV Healthcare
NCT04871113: A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults

Completed
2
62
Canada, US, RoW
GSK3810109A, Dolutegravir+lamivudine SOC regimen
ViiV Healthcare
HIV Infections
10/22
09/23
EMBRACE, NCT05996471: A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)

Active, not recruiting
2
128
US
VH3810109, Cabotegravir, Standard of care (SOC), rHuPH20
ViiV Healthcare
HIV Infections
11/24
01/29
SPAN, NCT05291520: A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants

Completed
1
24
US
VH3810109, rHuPH20
ViiV Healthcare
HIV Infections
04/23
04/23
MVA/HIV62B vaccine / National Institute of Allergy and Infectious Diseases
NCT04357821: Combinatorial Therapy to Induce an HIV Remission

Active, not recruiting
1/2
11
US
Combination Intervention
University of California, San Francisco, amfAR, The Foundation for AIDS Research, International AIDS Vaccine Initiative, Ichor Medical Systems Incorporated, National Institute of Allergy and Infectious Diseases (NIAID), Rockefeller University, Mologen AG, GeoVax, Inc.
HIV/AIDS
12/25
12/25
elvitegravir/tenofovir alafenamide insert (TAF/EVG insert) / CONRAD, National Institute of Allergy and Infectious Diseases
RITE PrEP, NCT06274398: Rectal Insert TAF/EVG Pre-Exposure Prophylaxis () Study

Recruiting
1
24
US
TAF/EVG rectal insert, Matching placebo rectal insert
Eastern Virginia Medical School, CONRAD, Emory University, Centers for Disease Control and Prevention
Safety Issues
10/24
12/24
gp145 C.6980 vaccine / National Institute of Allergy and Infectious Diseases
NCT04826094: A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya

Completed
1
143
RoW
Env-C Plasmid DNA, HIV Env gp145 C.6980 protein, Rehydragel®, ALF43, dmLT, Placebo (IM), Placebo (TCl)
National Institute of Allergy and Infectious Diseases (NIAID), Walter Reed Army Institute of Research (WRAIR), US Military HIV Research Program, The Emmes Company, LLC
HIV Infections
02/24
02/24
PGDM1400 / National Institute of Allergy and Infectious Diseases, IAVI
NCT04983030: Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults

Active, not recruiting
1/2
36
US
Ad26.Mos4.HIV, MVA-BN-HIV, PGT121, PGDM1400, VRC07-523LS
Boris Juelg, MD PhD, Janssen Pharmaceuticals, Harvard School of Public Health (HSPH), National Institute of Allergy and Infectious Diseases (NIAID)
HIV, Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndrome, Acquired, Sexually Transmitted Diseases, Viral, Retroviridae Infections
02/26
04/26
VRC07-523LS / National Institute of Allergy and Infectious Diseases, IAVI, TaiMed Biologics
NCT03739996: Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1

Completed
2
75
US
Oral Cabotegravir (CAB), Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Long-Acting Injectable Cabotegravir (CAB LA), VRC07-523LS, VRC-HIVMAB075-00-AB, Standard of Care (SOC) ART
National Institute of Allergy and Infectious Diseases (NIAID), ViiV Healthcare
HIV Infections
04/24
04/24
NCT05281510: Study of VRC07-523LS, CAP256V2LS, and Vesatolimod, in Early Antiretroviral-treated HIV-1 Clade C-infected Women

Completed
2
20
RoW
Vesatolimod, GS-9620, VRC07523LS, CAP256V2LS
Gilead Sciences
HIV-1-infection
01/25
01/25
NCT06812494: A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV

Recruiting
2
200
US, RoW
VRC07-523LS 400mg, PGT121.414.LS 400mg, PGDM1400LS 400mg, VRC07-523LS 3200mg, PGT121.414.LS 1600mg, PGDM1400LS 1600mg
National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services, Dale and Betty Bumpers Vaccine Research Center (VRC)
HIV
01/27
09/27
NCT05719441: A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

Suspended
2
48
US, RoW
VRC07-523LS, VRC-HIVMAB075-00-AB, PGT121.414.LS, VRC-HIVMAB0107-00-AB, Placebo, ART, Biktarvy
National Institute of Allergy and Infectious Diseases (NIAID)
Acute HIV Infection
04/28
09/28
NCT05275998: TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals

Completed
1/2
51
US
TMB-365/TMB-380, TMB-380 is also known as VRC07-523-LS
TaiMed Biologics Inc.
HIV-1-infection
11/24
11/24
NCT06508749: The Tatelo Plus Study

Recruiting
1/2
41
RoW
PGDM1400LS, VRC07-523LS, PGT121.414.LS, ART Regimen prior to enrolling in Step 1a, ART Regimen prior to enrolling in Step 1b, Analytic Treatment Interruption
National Institute of Allergy and Infectious Diseases (NIAID)
HIV, HIV Infections
11/27
04/28
NCT05184452: A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants

Completed
1
95
US, RoW
PGDM1400LS (5mg/kg, IV), PGDM1400LS (20mg/kg, IV), PGDM1400LS (20mg/kg, SC), PGDM1400LS (40mg/kg, IV), PGDM1400LS (40mg/kg, SC), PGDM1400LS (1.4g, IV), PGDM1400LS (1.4g, SC), VRC07-523LS (20mg/kg, IV), VRC07-523LS (20mg/kg, SC), VRC07-523LS (1.4g, IV), VRC07-523LS (1.4g, SC), VRC07-523LS (40mg/kg, IV), PGT121.414.LS (20mg/kg, IV), PGT121.414.LS (20mg/kg, SC), PGT121.414.LS (1.4g, IV), PGT121.414.LS (1.4g, SC), PGT121.414.LS (40mg/kg, IV)
National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services
HIV Infections
07/23
07/23
NCT05890963: 10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults

Active, not recruiting
1
20
RoW
ART, antiretroviral therapy, 10E8.4/iMab, ibalizumab, VRC07-523LS, VRC01 variant
David Ho, Henry M. Jackson Foundation for the Advancement of Military Medicine, US Military HIV Research Program, National Institute of Allergy and infectious Diseases (NIAID)/Vaccine Research Center (VRC)
HIV-1-infection
04/26
05/27
ACHIEV, NCT06484335: RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (

Not yet recruiting
1
48
RoW
VRC07-523LS, PGDM1400LS, ChAdOx1.tHIVconsv1, ChAdOx1.HIVconsv62, MVA.tHIVconsv4, A244d11 gp120, ALFQ, Placebo
Henry M. Jackson Foundation for the Advancement of Military Medicine, US Military HIV Research Program
HIV Infections, PLWH, ART, Acute HIV Infection
08/27
08/27
NCT06517693: Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1

Not yet recruiting
1
48
US, RoW
PGT121.414.LS, VRC07-523LS
National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institute of Allergy and Infectious Diseases Vaccine Research Center (NIAID VRC)
HIV-1
12/27
06/28
NCT06987318: A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection

Not yet recruiting
1
40
US, RoW
VRC07-523LS, PGT121.414.LS
National Institute of Allergy and Infectious Diseases (NIAID), Monogram Biosciences
HIV-1-infection
08/27
05/28
RV582, NCT05769569: Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission

Withdrawn
1
35
RoW
VRC07-523LS, VRC-HIVMAB075-00-AB, PGDM1400LS, N-803, Ad26.Mos4.HIV, MVA-BN-HIV, A244d11 gp120, ALFQ, Antiretroviral Therapy (ART)
Henry M. Jackson Foundation for the Advancement of Military Medicine, US Military HIV Research Program, Janssen Vaccines & Prevention B.V.
HIV-1-infection
07/25
07/25
NCT04340596: Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption

Active, not recruiting
1
118
US
N-803 (IL-15 Superagonist), VRC07-523LS, 10-1074
National Institute of Allergy and Infectious Diseases (NIAID), Rockefeller University, ImmunityBio, Inc.
HIV Infection
06/26
12/26
DNA-HIV-PT123 vaccine / EuroVacc, National Institute of Allergy and Infectious Diseases
PrEPVacc, NCT04066881: A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP

Enrolling by invitation
2b
1668
RoW
Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48), Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48), Vaccine Group C: Saline placebo (weeks 0,4,24,48), Control PrEP:TDF/FTC once daily (weeks 0-26), Truvada, Experimental PrEP:TAF/FTC once daily (weeks 0-26), Descovy
MRC/UVRI and LSHTM Uganda Research Unit, Imperial College London, University College, London, International AIDS Vaccine Initiative, EuroVacc Foundation, Medical Research Council, South Africa, National Institute for Medical Research, Tanzania, Muhimbili University of Health and Allied Sciences, Instituto Nacional de Saúde, Mozambique, Ludwig-Maximilians - University of Munich, King's College London, Centre Hospitalier Universitaire Vaudois, Karolinska Institutet, CONRAD, Gilead Sciences
HIV Infections
12/24
12/24
2020-005888-31: Not applicable

Not yet recruiting
1/2
70
Europe
DREP-HIV-PT1, DNA-HIV-PT123, CN54gp140, MPLA-L, SUB259135, SUB217960/SUB217962/SUB217961, SUB259133, Solution for injection, Solution for injection in vial, Suspension for injection
Inserm-ANRS, ANRS, Horizon 2020
it's a Phase 1-2 preventive , prophilactic HIV vaccine trial.Vaccine target are healthy subjects aged from 18 to 55 years old. Safety and the immunogenicity of DREP-HIV-PT1 vaccine will be evaluated at first alone then in comparaison to the DNA-HIV-PT123 vacccine with CN54gp140 adjuvanted by MPLA-L coinjection. DREP-HIV-PT1 will be injected intramuscularly via the Stratis device (needle free seringue) manufactured by PharmaJet, the other products will be injected with a seringue with needle., It's a FIH trial and will be performed on healthy subjects with a prophylactic HIV vaccine., Diseases [C] - Virus Diseases [C02]
 
 
NCT04842682: Dose Escalation Trial of CD40.HIVRI.Env Vaccine Combined or Not With a DNA-HIV-PT123 HIV-1 Vaccine in Healthy Volunteers

Completed
1
72
Europe
Solo 0.3 group, Solo 1 group, Solo 3 group, Combi 0.3 group, Combi 1 group, Combi 3 group, Late boost CD40 alone, Late boost CD40 adjuvanted
ANRS, Emerging Infectious Diseases
Healthy Adults
11/24
11/24
NCT04844775: A Prophylactic HIV Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DREP Alone and in Combination With a Clade C ENV Protein in Healthy HIV-uninfected Adults

Active, not recruiting
1
68
Europe
Drep-HIV-PT1 0.2mg and CN54gp140/MPLA-L, DREP-HIV-PT1 1mg and CN54gp140/MPLA-L (see above), DNA-HIV-PT123 4mg and CN54gp140/MPLA-L
ANRS, Emerging Infectious Diseases, Medical Research Council, Henri Mondor University Hospital, Chelsea and Westminster Hospital, UK, EuroVacc Foundation, European Commission, Swiss Government, University College London Hospitals, Imperial College London, Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
Healthy Adults
09/24
09/24
OVX836 / Osivax, National Institute of Allergy and Infectious Diseases
NCT05569239: Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg

Not yet recruiting
2b
1500
NA
OVX836 480µg, Saline Solution
Osivax, Hôpital Cochin, Clinact
Influenza
12/23
07/24
NCT05060887 / 2021-002535-39: Immunogenicity and Safety of Three Dose Levels of OVX836 Candidate Vaccine Against Influenza in Healthy Volunteers.

Completed
2a
239
Europe
OVX836-003, Saline solution
Osivax, Center for vaccinology (CEVAC), University of Ghent
Influenza
02/22
12/22
2019-002939-28: A phase 2a, single center, randomized, observer blind, controlled study to evaluate the immunogenicity and the safety of one dose of OVX836 influenza vaccine at two dose levels (90 µg and 180 μg), in comparison to Influvac TetraTM, quadrivalent seasonal influenza sub-unit vaccine, after intramuscular administration in healthy subjects aged 18-65 years

Not yet recruiting
2
300
Europe
OVX836, Solution for injection
OSIVAX, Osivax
Healthy Volunteers (influenza Vaccine)Influenza infection is a major cause of respiratory disease that affects all age groups, leading to significant morbidity and mortality. Complications of influenza include otitis media, pneumonia, exarcerbations of chronic respiratory disease and bionchiolitis (in children) but also nonrespiratory complications such as febrile convulsions or myocarditis, Prevention of influenza disease irrespective of strains (seasonal and/or pandemic), Diseases [C] - Respiratory Tract Diseases [C08]
 
 
NCT05734040: Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects.

Completed
2
478
RoW
OVX836 480µg, Fluarix Tetra, Afluria Quad, Placebo
Osivax, Novotech (Australia) Pty Limited, Mater Misericordiae Limited
Influenza
08/23
01/24
NCT06582277: Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836

Completed
2
117
Europe
OVX836 shot
Osivax, Harmony Clinical Research BVBA, Clinfidence, Inferential, University Hospital, Ghent, KCAS Bio
Vaccine-Preventable Diseases, Influenza
06/25
06/25
VRC-MALMAB0100-00-AB / National Institute of Allergy and Infectious Diseases
NCT04329104: Safety and Efficacy of CIS43LS Anti-malaria mAb in Mali

Completed
2
348
RoW
VRC-MALMAB0100-00-AB (CIS43LS), Normal saline
National Institute of Allergy and Infectious Diseases (NIAID), Malaria Research and Training Center, Bamako, Mali, University of Washington, Harvard School of Public Health (HSPH)
Plasmodium Falciparum Infection, Malaria
01/22
07/23
oral live-attenuated Shigella sonnei vaccine (WRSs2) / National Institute of Allergy and Infectious Diseases
NCT04242264: Phase 2 Shigella Vaccine and Challenge

Completed
2
69
US
Placebo, Shigella sonnei strain 53G, WRSs2
National Institute of Allergy and Infectious Diseases (NIAID)
Immunisation, Shigella Infection
03/24
07/24
bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
UNITED, NCT04639479: At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19

Not yet recruiting
4
7500
NA
bamlanivimab
Daniel Griffin, MD PhD, Eli Lilly and Company, Optum, Inc.
Covid19
05/21
05/21
B-EPIC, NCT04796402: A Study to Assess if a Medicine Called Bamlanivimab is Safe and Effective in Reducing Hospitalization Due to COVID-19

Active, not recruiting
4
576
Canada
Bamlanivimab, Standard of Care
Fraser Health, Fraser Health Authrority Department of Evaluation and Research Services, Surrey Memorial Hospital Clinical Research Unit, Centre for Health Evaluation and Outcome Sciences, Surrey Hospital Foundation, BC Support Unit, University of British Columbia, Ministry of Health, British Columbia, Clinical Trials BC (part of the BC Academic Health Science Network)
Covid19
06/21
12/21
NCT05780268: LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Completed
3
314
Europe, US, RoW
LY3819253, Placebo, Remdesivir, Veklury
National Institute of Allergy and Infectious Diseases (NIAID), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Eli Lilly and Company, University of Minnesota
COVID-19
02/21
02/21
2021-002612-31: Adaptive, randomized, placebo-controlled trial to evaluate the efficacy of monoclonal antibodies in outpatients with mild or moderate COVID-19 (MANTICO) Studio clinico adattativo, randoMizzato, controllato con placebo, sull’uso di ANTIcorpi monoclonali nei pazienti affetti da forma lieve-moderata di COvid-19 (MANTICO)

Not yet recruiting
3
1260
Europe
Bamlanivimab, CASIRIVIMAB/IMDEVIMAB, ETESEVIMAB, [Bamlanivimab], [CASIRIVIMAB/IMDEVIMAB], [ETESEVIMAB], Concentrate for solution for injection/infusion, .
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA, AIFA - Italian Medicines Agency
COVID-19 COVID-19, COVID-19 COVID-19, Diseases [C] - Virus Diseases [C02]
 
 
TICO, NCT04501978 / 2020-003278-37: ACTIV-3: Therapeutics for Inpatients With COVID-19

Completed
3
2753
Europe, US, RoW
LY3819253, Placebo, Remdesivir, VIR-7831, BRII-196/BRII-198, AZD7442, AZD8895 + AZD1061, MP0420, ensovibep, PF-07304814
National Institute of Allergy and Infectious Diseases (NIAID), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Eli Lilly and Company, Vir Biotechnology, Inc., GlaxoSmithKline, Brii Biosciences Limited, AstraZeneca, Molecular Partners AG, Pfizer, University of Minnesota
Covid19
04/22
07/23
NCT04518410: ACTIV-2: A Study for Outpatients With COVID-19

Hourglass Jul 2022 - Dec 2022 : Data from ACTIV-2 trial for COVID-19
Hourglass May 2022 - Dec 2022 : Data from ACTIV-2 trial for the treatment of COVID-19
Checkmark Safety and efficacy data from ACTIV-2 P2/3 trial for the treatment for COVID-19
Jan 2022 - Jan 2022: Safety and efficacy data from ACTIV-2 P2/3 trial for the treatment for COVID-19
Checkmark Data from ACTIV-2 trial in combination with BRII-198 for COVID-19
More
Completed
2/3
4044
Canada, US, RoW
bamlanivimab 7000mg, LY3819253, BRII-196+BRII-198, AZD7442 (IV), AZD8895 + AZD1061, AZD7442 (IM), SNG001, Camostat, FOY-305, camostat mesilate, camostat mesylate, BMS-986414 + BMS-986413, C135-LS + C144-LS, SAB-185 (3,840 Units/kg), Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived), SAB-185 (10,240 Units/kg), CASIRIVIMAB + IMDEVIMAB, REGN10933 + REGN10987, REGN-COV2, Placebo for Bamlanivimab 7000mg, Placebo for Bamlanivimab 700mg, Placebo for BRII-196+BRII-198, Placebo for SNG001, Placebo for Camostat, Placebo for SAB-185 (low dose), Placebo for BMS-986414 + BMS-986413, Placebo for AZD7442 (IV), Placebo for AZD7442 (IM), Placebo for SAB-185 (high dose), bamlanivimab 700mg
National Institute of Allergy and Infectious Diseases (NIAID), Eli Lilly and Company, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, Brii Biosciences Limited, AstraZeneca, Sagent Pharmaceuticals, Synairgen Research Ltd., Bristol-Myers Squibb, SAb Biotherapeutics, Inc.
Coronavirus, Covid19
04/22
06/23
BLAZE-1, NCT04427501: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness

Completed
2/3
3307
US
LY3819253, LY-CoV555, Bamlanivimab, LY3832479, LY-CoV016, Etesevimab, LY3853113, bebtelovimab, Placebo
Eli Lilly and Company, AbCellera Biologics Inc., Shanghai Junshi Bioscience Co., Ltd.
COVID-19
02/23
02/23
NCT04840459: Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting

Recruiting
2
1000
US
BAMLANIVIMAB, CASIRIVIMAB, IMDEVIMAB
Sohail Rao
Covid19
12/22
01/23
NCT04603651: Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19

No Longer Available
N/A
NA
Bamlanivimab, LY3819253, LY-CoV555
Eli Lilly and Company, AbCellera Biologics Inc.
COVID-19
 
 
CONDIVIDIAMO, NCT05268601: COVID-19 and Disease Progression to the Severe Form: a Study on the Use of Monoclonal Antibodies Against SARS-CoV-2

Completed
N/A
251
Europe
Bamlanivimab, Bamlanivimab and Etesevimab Drug Combination, Casirivimab and Imdevimab Drug Combination, Sotrovimab
University of Milano Bicocca
COVID-19
12/23
12/23
Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
2022-000905-29: Temporal kinetics of antibody and cellular response markers and relative impact of revaccination in patients recovered from COVID-19 after treatment with monoclonal antibodies Cinetica tempoRale dei marcatori di risposta anticorpale e cEllulare e relativo impatto della rivacciNazione in pazienti guariti dalla COVID-19 dopo trattamento con anticoRpi monoclonali

Not yet recruiting
4
150
Europe
Evusheld, Xevudy, Comirnaty, Spikevax, Nuvaxovid, [-], Solution for injection, Concentrate for solution for infusion, Dispersion for injection, Evusheld, Xevudy, Comirnaty, Spikevax, Nuvaxovid
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
Covid-19 infection Infezione da Covid-19, Covid-19 infection Infezione da Covid-19, Diseases [C] - Virus Diseases [C02]
 
 
LUNAR, NCT05305651: Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19

Completed
4
217
Europe
Sotrovimab
GlaxoSmithKline
COVID-19
07/23
07/23
NCT05780281: VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Completed
3
367
Europe, US, RoW
VIR-7831, Placebo, Remdesivir, Veklury
National Institute of Allergy and Infectious Diseases (NIAID), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Vir Biotechnology, Inc., GlaxoSmithKline, University of Minnesota
COVID-19
06/21
10/22
2021-004188-28: A Phase III Randomized, Open-label, Multicenter Study to Determine the Safety and Efficacy of different MONoclonal Antibodies (MoAbs) to SARS-CoV-2 for the Early Treatment of COVID-19 in Non-hospitalized Adults Studio di fase 3, a braccio aperto, randomizzato di pazienti con un test per SARS-Cov-2 positivo documentato e sintomi lievi di COVID19, non ospedalizzati e reclutati in Italia. Questo studio valuta l’efficacia di anticorpi monoclonali multipli paragonati alla Standard of care (SOC) per il trattamento del Covid-19 in pazienti adulti non ospedalizzati

Not yet recruiting
3
1550
Europe
Imdevimab, Sotrovimab, Casirivimab, [-], Concentrate for solution for injection/infusion, Infusion, Concentrate for solution for infusion
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI", AIFA - Italian Medicines Agency
COVID-19 infection Infezione da COVID-19, COVID-19 infection Infezione da COVID-19, Diseases [C] - Virus Diseases [C02]
 
 
2021-004266-35: A multicenter clinical trial to compare the efficacy and safety of Casirivimab and Imdevimab or Bamlanivimab and Etesevimab or Sotrovimab in high risk COVID-19 hospital admission patients. Uno studio clinico multicentrico per confrontare l'efficacia e la sicurezza degli Anticorpi Monoclonali Casirivimab e Imdevimab o Bamlanivimab ed Etesevimab o Sotrovimab in pazienti domiciliari COVID-19 ad alto rischio di ricovero.

Ongoing
3
552
Europe
Casirivimab/imdevimab, Sotrovimab, Bamlanivimab/Etesevimab, [ronapreve], [VIR-7831], [Bamlanivimab/Etesevimab], Concentrate for solution for injection/infusion, Concentrate and solvent for solution for injection, casirivimab/imdevimab, Sotrovimab, Bamlanivimab/Etesevimab
AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA, AIFA - Italian Medicines Agency
Mild to moderate COVID-19 patients at high risk of progression to severe COVID-19 and / or hospitalization pazienti affetti da COVID-19 da lieve a moderato ad alto rischio di progressione a COVID-19 grave e/o ricovero ospedaliero, COVID-19 patients pazienti affetti da COVID-19, Diseases [C] - Virus Diseases [C02]
 
 
NCT04913675 / 2021-000623-13: Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.

Checkmark Efficacy and safety data from COMET-TAIL trial for early treatment of mild-to-moderate COVID-19
Nov 2021 - Nov 2021: Efficacy and safety data from COMET-TAIL trial for early treatment of mild-to-moderate COVID-19
Terminated
3
1065
Europe, US, RoW
sotrovimab, Sotrovimab
Vir Biotechnology, Inc., GlaxoSmithKline
Covid19
07/22
03/23
MANTICO 2, NCT05321394: Non-inferiority Trial on Treatments in Early COVID-19

Completed
3
536
Europe
Sotrovimab, Tixagevimab Cilgavimab, Nirmatrelvir Ritonavir
Azienda Ospedaliera Universitaria Integrata Verona, Agenzia Italiana del Farmaco, Azienda Sanitaria-Universitaria Integrata di Udine
COVID-19
10/23
10/23
RECOVERY, NCT04381936 / 2020-001113-21: Randomised Evaluation of COVID-19 Therapy

Checkmark Efficacy and safety data from RECOVERY trial in COVID-19
Jun 2021 - Jun 2021: Efficacy and safety data from RECOVERY trial in COVID-19
Recruiting
3
70000
Europe, RoW
Lopinavir-Ritonavir, Corticosteroid, Hydroxychloroquine, Azithromycin, Convalescent plasma, Tocilizumab, Immunoglobulin, Synthetic neutralising antibodies, REGEN-COV, casirivimab and imdevimab, Aspirin, Colchicine, Baricitinib, Anakinra, Dimethyl fumarate, High Dose Corticosteroid, Empagliflozin, Sotrovimab, Molnupiravir, Paxlovid, nirmatrelvir/ritonavir, Baloxavir Marboxil, Xofluza, Oseltamivir, Tamiflu, Low-dose corticosteroids: Dexamethasone
University of Oxford, UK Research and Innovation, National Institute for Health Research, United Kingdom, Wellcome, Bill and Melinda Gates Foundation, Department for International Development, United Kingdom, Health Data Research UK, Medical Research Council Population Health Research Unit, NIHR Clinical Trials Unit Support Funding, NIHR Health Protection Research Unit in Emerging and Zoonotic Infections, Flu Lab
Severe Acute Respiratory Syndrome
06/26
06/36
PROTECT-V, NCT04870333 / 2020-004144-28: PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V

Completed
2/3
2240
Europe
Niclosamide, Placebo, Ciclesonide, Sotrovimab
Cambridge University Hospitals NHS Foundation Trust, Life Arc, Kidney Research UK (KRUK), UNION therapeutics, Addenbrookes Charitable Trust, GlaxoSmithKline, National Institute for Health Research, United Kingdom
Covid19
04/25
04/25
COMET-ACE, NCT04766671: An Exploratory Study to Describe Virological Effect, Safety, and Pharmacokinetics of VIR-7831 Monoclonal Antibody in Hospitalized Participants With COVID-19

Not yet recruiting
2
150
NA
VIR-7831, Placebo, Standard of care
GlaxoSmithKline, Vir Biotechnology, Inc.
COVID-19
08/21
06/22
2021-006495-16: Immunogenicity and safety of Sotrovimab (Vir 7831) IV as primary prophylaxis in anti-SARS-CoV-2 vaccine non responders Immunogenicità e sicurezza di Sotrovimab (Vir 7831) IV come profilassi primaria nei non responders al vaccino anti-SARS-CoV-2

Not yet recruiting
2
100
Europe
Sotrovimab, [-], Infusion
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI", GlaxoSmithKline, VIR Biotechnology
Covid 19 Infection Infezione da Covid 19, Covid 19 Infection Infezione da Covid 19, Diseases [C] - Virus Diseases [C02]
 
 
NCT05210101: A Safety and Tolerability Study of Sotrovimab (VIR-7831) Prophylaxis Against COVID-19 in Immunocompromised Individuals

Completed
2
93
US
Sotrovimab, VIR-7831
Sophia Koo, M.D., Massachusetts General Hospital, Dana-Farber Cancer Institute, GlaxoSmithKline
SARS CoV 2 Infection
02/23
02/23
COMET-PACE, NCT05124210 / 2021-003717-18: Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19

Terminated
2
8
US
Sotrovimab
GlaxoSmithKline, Vir Biotechnology, Inc.
COVID-19
06/23
06/23
PLATCOV, NCT05041907: Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19

Recruiting
2
3800
RoW
Nirmatrelvir/ritonavir (e.g. PAXLOVID™), Nitazoxanide, Molnupiravir and nirmatrelvir/ritonavir (e.g. PAXLOVID™), Hydroxychloroquine, No treatment, Monoclonal antibodies, Fluoxetine, Molnupiravir, Sotrovimab, Ensitrelvir, Favipiravir, Ivermectin, Remdesivir, Atilotrelvir/ritonavir, Metformin, Nirmatrelvir/ritonavir, Nirmatrelvir
University of Oxford
COVID-19
01/27
01/27
NCT04746183: AGILE (Early Phase Platform Trial for COVID-19)

Hourglass Jan 2022 - Jun 2022 : Data from AGILE trial for COVID-19
Active, not recruiting
1/2
600
Europe, RoW
CST-2: EIDD-2801, MK-4482, Molnupiravir, CST-2: Placebo, Placebo, Nitazoxanide, VIR-7832, VIR-7831, Sotrovimab, CST-5: Placebo, Favipiravir, Lagevrio, Paxlovid, nirmatrelvir and ritonavir
University of Liverpool, University of Southampton, Liverpool School of Tropical Medicine, Liverpool University Hospitals NHS Foundation Trust, University of Cambridge
Covid19
07/25
07/25
COSMIC, NCT05280717: Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults

Terminated
1
316
US
sotrovimab
Vir Biotechnology, Inc., GlaxoSmithKline
Covid19
04/23
11/23
EHS-Strategy, NCT05144178: Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab )

Recruiting
N/A
3500
RoW
Emirates Health Services (EHS)
COVID-19 Respiratory Infection
01/22
02/22
NCT05235347: Sotrovimab Expanded Access Treatment Protocol (COVID-19)

No Longer Available
N/A
US
Sotrovimab
Vir Biotechnology, Inc.
Covid19
 
 
COVID-PR, NCT05013632: COVID-19 International Drug Pregnancy Registry

Recruiting
N/A
2000
US
Antiviral Agents, Veklury (remdesivir), Lagevrio (molnupiravir), Monoclonal antibody, REGEN-COV (casirivimab/imdevimab), Xevudy (sotrovimab)
Pregistry
Covid19
09/27
09/27
NCT05398718: Study on Sotrovimab and Its Impact on the Immune Response to COVID-19 Infection in Real-life in the UAE and Bahrain

Recruiting
N/A
20000
RoW
Sotrovimab
Abu Dhabi Health Services Company
COVID-19
12/22
12/22
TURN-COVID, NCT05195060: Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other Antiviral Agents Against SARS-CoV-2

Recruiting
N/A
1000
Europe
casirivimab with imdevimab, REGEN-COV, sotrovimab, Xevudy, molnupiravir, Lagevrio
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
COVID-19
06/24
06/24
CAP256V2LS / National Institute of Allergy and Infectious Diseases
NCT04408963: A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults

Completed
1
10
US
VRC-HIVMAB0102-00-AB, CAP256V2LS
National Institute of Allergy and Infectious Diseases (NIAID)
HIV
11/22
11/22
PGT121.414.LS / National Institute of Allergy and Infectious Diseases
HVTN143, NCT05959707: Evaluating the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies in Healthy Participants

Suspended
1
77
RoW
VRC01.23LS, PGT121.414.LS, PGDM1400LS
HIV Vaccine Trials Network, National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
01/25
01/25
zinlirvimab (GS-2872) / Gilead
2019-002129-31: The RIO Trial: A randomised placebo controlled trial of ART plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) vs ART plus placebo in treated Primary HIV Infection on viral control off ART

Not yet recruiting
2
72
Europe
3BNC117-LS, 10-1074-LS, 3BNC117-LS, 10-1074-LS, Solution for infusion
Imperial College London, Bill & Melinda Gates Foundation
HIV infection, HIV infection, Diseases [C] - Virus Diseases [C02]
 
 
RIO, NCT04319367 / 2019-002129-31: A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs).

Recruiting
2
72
Europe
Investigational Medicinal Product, 10-1074-LS and 3BNC117-LS
Imperial College London, Bill and Melinda Gates Foundation, University of Oxford, Rockefeller University
HIV/AIDS and Infections
07/27
07/27
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Ervebo (recombinant vesicular stomatitis virus (VSV) expressing the envelope glycoprotein of Ebola Virus Zaire) / Merck (MSD)
NCT05992480: REVIVE (Response to the Ebola Virus Vaccine)

Not yet recruiting
4
40
RoW
rVSVDG-ZEBOV-GP Ebola Virus Vaccine (ERVEBO)
Tulane University, Kenema Government Hospital, Merck Sharp & Dohme LLC
Ebola Virus Disease
01/26
02/26
NCT06587503: Safety and Immunogenicity of rVSVΔG-ZEBOV-GP Vaccination When Dosed Concurrently With mRNA COVID-19 Vaccine Booster Doses

Not yet recruiting
4
72
NA
BioNTech - Pfizer COVID-19 vaccine, Cominarty, 1mL saline solution, rVSV∆G-ZEBOV-GP, Ervebo
University of Birmingham, Project San Francisco, Rwanda Biomedical Centre, Merck Sharp & Dohme LLC
Ebola Virus Disease, COVID-19
12/24
05/25
EBO-BOOST, NCT06126822: Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC

Recruiting
3
624
RoW
Zabdeno® booster, Ervebo® booster
Institute of Tropical Medicine, Belgium, Institut National pour la Recherche Biomedicale (INRB)
Ebola Virus Disease
10/26
10/26
EBO-PEP, NCT06841614: EBOla Post-Exposure Prophylaxis

Not yet recruiting
3
160
RoW
Ervebo, r-VSV-ZEBOV vaccine, Inmazeb, REGN-EB3
ANRS, Emerging Infectious Diseases, Alliance for International Medical Action, Centre de Recherche et de Formation en Infectiologie de Guinée (CERFIG), Medecins Sans Frontieres, Netherlands, Barcelona Institute for Global Health, University of Bordeaux, INSERM 1136, Agence Nationale de Sécurité Sanitaire de Guinée (ANSS), National Institute for Biomedical Research DRC, Cheikh Anta Diop University, Senegal, PACCI Program, The PANdemic preparedness plaTform for Health and Emerging infectious Response, University of Sierra Leone College of Medicine and Allied Health Sciences, National Public Health Institute of Liberia
Ebola Virus Disease
06/27
12/27
PREPARE, NCT05959421: Immunity Induced by VSV-EBOV and Assessment of a Booster Dose in Individuals at Potential Occupational Risk for Exposure

Not yet recruiting
3
70
Europe
ERVEBO® (rVSV∆G-ZEBOV-GP)
Universitätsklinikum Hamburg-Eppendorf, Bernhard Nocht Institute for Tropical Medicine, Goethe University, German Federal Ministry of Education and Research, Monipol Deutschland GmbH
Ebola Vaccine
12/27
06/28
PROVAE, NCT04822376: Prophylaxis Vaccine Antibodies Ebola

Not yet recruiting
2a
250
RoW
ansuvimab, mab114, Ervebo, VSV-ZEBOV
ANRS, Emerging Infectious Diseases
Ebola Virus Disease
04/22
04/22
NCT05202288: Pilot Study Evaluating the Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers

Not yet recruiting
2a
135
RoW
Ervebo, r-VSV-ZEBOV vaccine, Inmazeb, REGN-E3B
ANRS, Emerging Infectious Diseases, Alliance for International Medical Action, University of Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France, Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire, Agence Nationale de Sécurité Sanitaire de Guinée (ANSS), Clinical and Operational Research Alliance (CORAL), Méthodologie et Evaluation pour la Recherche clinique et Epidémiologique sur le VIH en Afrique (MEREVA)
Ebola Virus Disease
03/23
03/23
NCT02876328 / 2019-001308-39: Partnership for Research on Ebola VACcinations

Completed
2
4789
RoW
Ad26.ZEBOV, rHAd26, MVA-BN-Filo, MVA, MVA-mBN226B, rVSVΔG-ZEBOV-GP, rVSV, V920, Placebo, rVSV boost
National Institute of Allergy and Infectious Diseases (NIAID), Partnership for Research on Ebola Virus in Liberia (PREVAIL), Institut National de la Santé Et de la Recherche Médicale, France, London School of Hygiene and Tropical Medicine, European and Developing Countries Clinical Trials Partnership (EDCTP)
Ebola Virus Disease
12/19
12/23
NCT03031912 / 2016-004853-34: African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola

Active, not recruiting
2
250
Canada
V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine, Saline
Cecile Tremblay, Merck Sharp & Dohme LLC, International Development Research Centre, Canada, Dalhousie University, Université de Montréal, Coalition for Epidemic Preparedness Innovations
Ebola
10/24
02/25
NCT02788227: Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV[Delta]G-ZEBOV-GP) for Pre-Exposure Prophylaxis (PREP) in People at Potential Occupational Risk for Ebola Virus Exposure

Completed
2
99
US
rVSV-Zebov GP vaccine
National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteers
06/25
06/25
NCT06100913: Immunology of Ebola Vaccine

Recruiting
2
30
US
Recombinant Vesicular Stomatitis Vaccine for Ebola (rVSV∆G-ZEBOV-GP), Ervebo
Emory University, Washington University School of Medicine, Merck Sharp & Dohme LLC
Ebola Virus Disease
12/26
12/26
EBOLAPED, NCT05130398: Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Living in Lambaréné, Gabon

Completed
1/2
120
RoW
rVSVΔG-ZEBOV-GP, V920, Fibre and equilibrate breakfast and lunch, Active detection and treatment of pathogens, Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogens, Chikenpox or Varicella vaccine (VARILRIX), Placebo
Centre de Recherche Médicale de Lambaréné, Merck Sharp & Dohme LLC
Ebola Virus Disease
09/21
08/22
NCT02257840: Safety and Immunogenicity of Prime-Boost VSV Ebola Vaccine in Healthy Adults

Recruiting
1
120
US
Placebo, BPSC1001
National Institute of Allergy and Infectious Diseases (NIAID)
Ebola Viruses
10/15
10/15
EBOSURV, NCT05313139: Surveillance of Vaccine-induced Immunity Against Ebola in Previously Vaccinated Health Care Workers

Recruiting
N/A
245
RoW
Institute of Tropical Medicine, Belgium
Immune Response
08/22
12/22
VRC01 / Acuitas Therap
NCT02140255: Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

Recruiting
1/2
1120
US, RoW
Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Nevirapine (NVP), Lopinavir/Ritonavir (LPV/r), Raltegravir (RAL), VRC01, DTG, VRC07-523LS
National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
HIV Infection
01/28
12/31
NCT03729752: PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)

Recruiting
1
30
US
[89]Zr-DFO-VRC-HIVMAB060-00-AB, [89]Zr-DFO-VRC01
University of California, San Francisco, amfAR, The Foundation for AIDS Research
HIV-1-infection
10/26
12/26
NCT06006546: The Study of Immunization in People Living With HIV Undergoing an ATI for Elicitation of VRC01-lineage Antibodies

Recruiting
1
40
US
426c.Mod.Core-C4b, Adjuvant 3M-052-AF+Alum
National Institute of Allergy and Infectious Diseases (NIAID)
Chronic HIV Infection
12/25
12/25
NCT04860323: Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study

Completed
N/A
13
RoW
Analytical Treatment Interruption
HIV Vaccine Trials Network, National Institute of Allergy and Infectious Diseases (NIAID), HIV Prevention Trials Network, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Infection
02/25
02/25
NCT04801758: Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 704/HPTN 085 AMP Study

Completed
N/A
18
RoW
Analytical Treatment Interruption
HIV Vaccine Trials Network, National Institute of Allergy and Infectious Diseases (NIAID), HIV Prevention Trials Network, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Infection
07/24
07/24
ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
2004-001525-21: Estudio clínico controlado con placebo, aleatorizado, de fase II, para evaluar la inmunogenicidad y la toxicidad de dos patrones de inducción-refuerzo complementarios con el ALVAC-VIH vCP1452 en pacientes con infección crónica del VIH

Ongoing
2
20
Europe
ALVAC(2)HIV (vCP1452), ALVAC(2)120(B,MN)GNP (vCP1452),
ORVACS, Objectif Recherche Vaccin SIDA
Infección por el VIH
 
 
NCT01435135: Study of Late Boost Strategies for HIV-uninfected Participants From Protocol RV 144

Active, not recruiting
2
162
RoW
ALVAC-HIV, (vCP1521), AIDSVAX B/E, ALVAC-HIV Placebo, AIDSVAX B/E Placebo
U.S. Army Medical Research and Development Command, National Institutes of Health (NIH)
HIV Infections
07/21
07/21
NCT01931358: Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX® B/E

Active, not recruiting
2
360
RoW
ALVAC-HIV, AIDSVAX B/E, ALVAC-HIV Placebo, AIDSVAX B/E Placebo
U.S. Army Medical Research and Development Command, National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
12/21
12/21
polyTregs / National Institute of Allergy and Infectious Diseases
TASK, NCT02711826: Treg Therapy in Subclinical Inflammation in Kidney Transplantation

Completed
1/2
32
US
Polyclonal Regulatory T Cells, Polyclonal Tregs, polyTregs, Everolimus, Zortress, Tacrolimus, FK-506, FR-900506, Prograf, Mycophenolate mofetil, Cellcept, MMF, Mycophenolic acid, Myfortic, MPA, Acetaminophen, Tylenol, Diphenhydramine, Benadryl, Biopsy, Kidney, Kidney Biopsy, Blood Draw, Phlebotomy, Venipuncture, Leukapheresis, leukocytapheresis, IS regimen conversion, Everolimus Conversion
National Institute of Allergy and Infectious Diseases (NIAID), Clinical Trials in Organ Transplantation
Kidney Transplant, Adult Living Donor Kidney Transplant Recipients, Renal Transplant, Living Kidney Donor
08/23
08/23
NCT03239470: Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus

Terminated
1
5
US
Cohort 1: 1.0 x 10^8 PolyTregs, Polyclonal Regulatory T Cells, autologous PolyTregs, CD4+CD127lo/negCD25+ PolyTregs, Cohort 2: 2.5x10^8 PolyTregs
National Institute of Allergy and Infectious Diseases (NIAID), Autoimmunity Centers of Excellence, Rho Federal Systems Division, Inc.
Pemphigus Foliaceus, Pemphigus Vulgaris
12/20
01/23
NCT03444064: PolyTreg Immunotherapy in Islet Transplantation

Completed
1
11
Canada
PolyTregs, Ex vivo Expanded Autologous CD4+CD127lo/-CD25+ Polyclonal Regulatory T cells
University of Alberta, Diabetes Research Institute Foundation, Liana's Dream Foundation, Juvenile Diabetes Research Foundation, Alberta Diabetes Institute
Diabetes, Diabetes Mellitus, Type 1
08/24
12/24
cePolyTregs, NCT05349591: in Islet Transplantation

Withdrawn
1
11
Canada
cePolytreg
University of Alberta, Juvenile Diabetes Research Foundation, Juvenile Diabetes Research Foundation Canadian Clinical Trial Network
Diabetes type1
05/25
05/25
Vimkunya (Chikungunya Vaccine, Recombinant) / Bavarian Nordic
CHIKV VLP, NCT05072080 / 2023-001124-42: A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 ( Vaccine)

Completed
3
3258
US
CHIKV VLP/adjuvant, Placebo
Bavarian Nordic, Emergent BioSolutions
Chikungunya Virus
04/23
04/23
NCT05349617: Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years

Completed
3
413
US
CHIKV VLP/adjuvant, Placebo
Bavarian Nordic, Emergent BioSolutions
Chikungunya Virus
06/23
08/23
2023-001124-42: A Phase 3 Clinical Trial to evaluate PXVX0317, a virus-like particle vaccine for active immunization to prevent disease caused by chikungunya virus.

Not yet recruiting
3
3150
US
CHIKV VLP vaccine, PXVX0317, Suspension for injection
Bavarian Nordic A/S, Bavarian Nordic A/S
Healthy Volunteers (Chikungunya disease. Prevention of Chikungunya disease by use of a vaccine), Healthy Volunteers (Prevention of Chikungunya disease), Diseases [C] - Virus Diseases [C02]
 
 
2025-000141-10: A multi-country study to test the safety and effectiveness of a chikungunya virus vaccine in children aged 2 to 11. The study is designed so that neither the participants nor the researchers know who is getting the vaccine and who is getting a placebo (an inactive substance).

Not yet recruiting
3
720
RoW, US
CHIKV VLP, CHIKV VLP, Suspension for injection, VIMKUNYA
Bavarian Nordic A/S, Bavarian Nordic A/S
Healthy Volunteers (Chikungunya disease. Prevention of Chikungunya disease by use of a vaccine.), Healthy Volunteers (Prevention of Chikungunya disease), Diseases [C] - Virus Diseases [C02]
 
 
NCT06007183: Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination

Active, not recruiting
3
800
US
CHIKV VLP vaccine booster, PXVX0317, Placebo booster
Bavarian Nordic
Chikungunya Virus Infection
04/28
08/28
2015-003556-44: investigational Chikungunya virus (CHIKV) vaccine study to evaluate the safety and Immunogenicity of a Chikungunya Virus

Not yet recruiting
2
400
Europe
VRC-CHKVLP059-00-VP, VRC-CHKVLP059-00-VP, Solution for injection in pre-filled syringe
IMEA Fondation Leon Mba, FHI360
To evaluate the safety and tolerability of VRC-CHKVLP059-00-VP vaccin in healthy adults that reside in CHIKV endemic ., To evaluate the safety and tolerability of VRC-CHKVLP059-00-VP in healthy adults that reside in CHIKV endemic, Body processes [G] - Immune system processes [G12]
 
 
rabies Vaccine (ChAd155-RG) / National Institute of Allergy and Infectious Diseases
NCT04019444: Dosage-Escalation Study of the Safety and Immunogenicity of a Novel Rabies Vaccine ChAd155-RG vs. the Comparator RABAVERT Vaccine in Healthy Adult Subjects

Completed
1
50
US
ChAd155-RG, Placebo, Rabies Vaccine
National Institute of Allergy and Infectious Diseases (NIAID)
Rabies, Rabies Immunisation
03/23
03/23
SAR441236 / Sanofi
NCT03705169: Pharmacokinetics and Safety of SAR441236

Terminated
1
52
US
SAR441236, Placebo
National Institute of Allergy and Infectious Diseases (NIAID), Sanofi, ModeX Therapeutics
HIV-1-infection
04/22
04/22
VH3810109 / ViiV Healthcare
NCT04871113: A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults

Completed
2
62
Canada, US, RoW
GSK3810109A, Dolutegravir+lamivudine SOC regimen
ViiV Healthcare
HIV Infections
10/22
09/23
EMBRACE, NCT05996471: A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)

Active, not recruiting
2
128
US
VH3810109, Cabotegravir, Standard of care (SOC), rHuPH20
ViiV Healthcare
HIV Infections
11/24
01/29
SPAN, NCT05291520: A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants

Completed
1
24
US
VH3810109, rHuPH20
ViiV Healthcare
HIV Infections
04/23
04/23
MVA/HIV62B vaccine / National Institute of Allergy and Infectious Diseases
NCT04357821: Combinatorial Therapy to Induce an HIV Remission

Active, not recruiting
1/2
11
US
Combination Intervention
University of California, San Francisco, amfAR, The Foundation for AIDS Research, International AIDS Vaccine Initiative, Ichor Medical Systems Incorporated, National Institute of Allergy and Infectious Diseases (NIAID), Rockefeller University, Mologen AG, GeoVax, Inc.
HIV/AIDS
12/25
12/25
elvitegravir/tenofovir alafenamide insert (TAF/EVG insert) / CONRAD, National Institute of Allergy and Infectious Diseases
RITE PrEP, NCT06274398: Rectal Insert TAF/EVG Pre-Exposure Prophylaxis () Study

Recruiting
1
24
US
TAF/EVG rectal insert, Matching placebo rectal insert
Eastern Virginia Medical School, CONRAD, Emory University, Centers for Disease Control and Prevention
Safety Issues
10/24
12/24
gp145 C.6980 vaccine / National Institute of Allergy and Infectious Diseases
NCT04826094: A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya

Completed
1
143
RoW
Env-C Plasmid DNA, HIV Env gp145 C.6980 protein, Rehydragel®, ALF43, dmLT, Placebo (IM), Placebo (TCl)
National Institute of Allergy and Infectious Diseases (NIAID), Walter Reed Army Institute of Research (WRAIR), US Military HIV Research Program, The Emmes Company, LLC
HIV Infections
02/24
02/24
PGDM1400 / National Institute of Allergy and Infectious Diseases, IAVI
NCT04983030: Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults

Active, not recruiting
1/2
36
US
Ad26.Mos4.HIV, MVA-BN-HIV, PGT121, PGDM1400, VRC07-523LS
Boris Juelg, MD PhD, Janssen Pharmaceuticals, Harvard School of Public Health (HSPH), National Institute of Allergy and Infectious Diseases (NIAID)
HIV, Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndrome, Acquired, Sexually Transmitted Diseases, Viral, Retroviridae Infections
02/26
04/26
VRC07-523LS / National Institute of Allergy and Infectious Diseases, IAVI, TaiMed Biologics
NCT03739996: Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1

Completed
2
75
US
Oral Cabotegravir (CAB), Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Long-Acting Injectable Cabotegravir (CAB LA), VRC07-523LS, VRC-HIVMAB075-00-AB, Standard of Care (SOC) ART
National Institute of Allergy and Infectious Diseases (NIAID), ViiV Healthcare
HIV Infections
04/24
04/24
NCT05281510: Study of VRC07-523LS, CAP256V2LS, and Vesatolimod, in Early Antiretroviral-treated HIV-1 Clade C-infected Women

Completed
2
20
RoW
Vesatolimod, GS-9620, VRC07523LS, CAP256V2LS
Gilead Sciences
HIV-1-infection
01/25
01/25
NCT06812494: A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV

Recruiting
2
200
US, RoW
VRC07-523LS 400mg, PGT121.414.LS 400mg, PGDM1400LS 400mg, VRC07-523LS 3200mg, PGT121.414.LS 1600mg, PGDM1400LS 1600mg
National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services, Dale and Betty Bumpers Vaccine Research Center (VRC)
HIV
01/27
09/27
NCT05719441: A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

Suspended
2
48
US, RoW
VRC07-523LS, VRC-HIVMAB075-00-AB, PGT121.414.LS, VRC-HIVMAB0107-00-AB, Placebo, ART, Biktarvy
National Institute of Allergy and Infectious Diseases (NIAID)
Acute HIV Infection
04/28
09/28
NCT05275998: TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals

Completed
1/2
51
US
TMB-365/TMB-380, TMB-380 is also known as VRC07-523-LS
TaiMed Biologics Inc.
HIV-1-infection
11/24
11/24
NCT06508749: The Tatelo Plus Study

Recruiting
1/2
41
RoW
PGDM1400LS, VRC07-523LS, PGT121.414.LS, ART Regimen prior to enrolling in Step 1a, ART Regimen prior to enrolling in Step 1b, Analytic Treatment Interruption
National Institute of Allergy and Infectious Diseases (NIAID)
HIV, HIV Infections
11/27
04/28
NCT05184452: A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants

Completed
1
95
US, RoW
PGDM1400LS (5mg/kg, IV), PGDM1400LS (20mg/kg, IV), PGDM1400LS (20mg/kg, SC), PGDM1400LS (40mg/kg, IV), PGDM1400LS (40mg/kg, SC), PGDM1400LS (1.4g, IV), PGDM1400LS (1.4g, SC), VRC07-523LS (20mg/kg, IV), VRC07-523LS (20mg/kg, SC), VRC07-523LS (1.4g, IV), VRC07-523LS (1.4g, SC), VRC07-523LS (40mg/kg, IV), PGT121.414.LS (20mg/kg, IV), PGT121.414.LS (20mg/kg, SC), PGT121.414.LS (1.4g, IV), PGT121.414.LS (1.4g, SC), PGT121.414.LS (40mg/kg, IV)
National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services
HIV Infections
07/23
07/23
NCT05890963: 10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults

Active, not recruiting
1
20
RoW
ART, antiretroviral therapy, 10E8.4/iMab, ibalizumab, VRC07-523LS, VRC01 variant
David Ho, Henry M. Jackson Foundation for the Advancement of Military Medicine, US Military HIV Research Program, National Institute of Allergy and infectious Diseases (NIAID)/Vaccine Research Center (VRC)
HIV-1-infection
04/26
05/27
ACHIEV, NCT06484335: RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (

Not yet recruiting
1
48
RoW
VRC07-523LS, PGDM1400LS, ChAdOx1.tHIVconsv1, ChAdOx1.HIVconsv62, MVA.tHIVconsv4, A244d11 gp120, ALFQ, Placebo
Henry M. Jackson Foundation for the Advancement of Military Medicine, US Military HIV Research Program
HIV Infections, PLWH, ART, Acute HIV Infection
08/27
08/27
NCT06517693: Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1

Not yet recruiting
1
48
US, RoW
PGT121.414.LS, VRC07-523LS
National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institute of Allergy and Infectious Diseases Vaccine Research Center (NIAID VRC)
HIV-1
12/27
06/28
NCT06987318: A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection

Not yet recruiting
1
40
US, RoW
VRC07-523LS, PGT121.414.LS
National Institute of Allergy and Infectious Diseases (NIAID), Monogram Biosciences
HIV-1-infection
08/27
05/28
RV582, NCT05769569: Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission

Withdrawn
1
35
RoW
VRC07-523LS, VRC-HIVMAB075-00-AB, PGDM1400LS, N-803, Ad26.Mos4.HIV, MVA-BN-HIV, A244d11 gp120, ALFQ, Antiretroviral Therapy (ART)
Henry M. Jackson Foundation for the Advancement of Military Medicine, US Military HIV Research Program, Janssen Vaccines & Prevention B.V.
HIV-1-infection
07/25
07/25
NCT04340596: Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption

Active, not recruiting
1
118
US
N-803 (IL-15 Superagonist), VRC07-523LS, 10-1074
National Institute of Allergy and Infectious Diseases (NIAID), Rockefeller University, ImmunityBio, Inc.
HIV Infection
06/26
12/26
DNA-HIV-PT123 vaccine / EuroVacc, National Institute of Allergy and Infectious Diseases
PrEPVacc, NCT04066881: A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP

Enrolling by invitation
2b
1668
RoW
Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48), Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48), Vaccine Group C: Saline placebo (weeks 0,4,24,48), Control PrEP:TDF/FTC once daily (weeks 0-26), Truvada, Experimental PrEP:TAF/FTC once daily (weeks 0-26), Descovy
MRC/UVRI and LSHTM Uganda Research Unit, Imperial College London, University College, London, International AIDS Vaccine Initiative, EuroVacc Foundation, Medical Research Council, South Africa, National Institute for Medical Research, Tanzania, Muhimbili University of Health and Allied Sciences, Instituto Nacional de Saúde, Mozambique, Ludwig-Maximilians - University of Munich, King's College London, Centre Hospitalier Universitaire Vaudois, Karolinska Institutet, CONRAD, Gilead Sciences
HIV Infections
12/24
12/24
2020-005888-31: Not applicable

Not yet recruiting
1/2
70
Europe
DREP-HIV-PT1, DNA-HIV-PT123, CN54gp140, MPLA-L, SUB259135, SUB217960/SUB217962/SUB217961, SUB259133, Solution for injection, Solution for injection in vial, Suspension for injection
Inserm-ANRS, ANRS, Horizon 2020
it's a Phase 1-2 preventive , prophilactic HIV vaccine trial.Vaccine target are healthy subjects aged from 18 to 55 years old. Safety and the immunogenicity of DREP-HIV-PT1 vaccine will be evaluated at first alone then in comparaison to the DNA-HIV-PT123 vacccine with CN54gp140 adjuvanted by MPLA-L coinjection. DREP-HIV-PT1 will be injected intramuscularly via the Stratis device (needle free seringue) manufactured by PharmaJet, the other products will be injected with a seringue with needle., It's a FIH trial and will be performed on healthy subjects with a prophylactic HIV vaccine., Diseases [C] - Virus Diseases [C02]
 
 
NCT04842682: Dose Escalation Trial of CD40.HIVRI.Env Vaccine Combined or Not With a DNA-HIV-PT123 HIV-1 Vaccine in Healthy Volunteers

Completed
1
72
Europe
Solo 0.3 group, Solo 1 group, Solo 3 group, Combi 0.3 group, Combi 1 group, Combi 3 group, Late boost CD40 alone, Late boost CD40 adjuvanted
ANRS, Emerging Infectious Diseases
Healthy Adults
11/24
11/24
NCT04844775: A Prophylactic HIV Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DREP Alone and in Combination With a Clade C ENV Protein in Healthy HIV-uninfected Adults

Active, not recruiting
1
68
Europe
Drep-HIV-PT1 0.2mg and CN54gp140/MPLA-L, DREP-HIV-PT1 1mg and CN54gp140/MPLA-L (see above), DNA-HIV-PT123 4mg and CN54gp140/MPLA-L
ANRS, Emerging Infectious Diseases, Medical Research Council, Henri Mondor University Hospital, Chelsea and Westminster Hospital, UK, EuroVacc Foundation, European Commission, Swiss Government, University College London Hospitals, Imperial College London, Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
Healthy Adults
09/24
09/24
OVX836 / Osivax, National Institute of Allergy and Infectious Diseases
NCT05569239: Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg

Not yet recruiting
2b
1500
NA
OVX836 480µg, Saline Solution
Osivax, Hôpital Cochin, Clinact
Influenza
12/23
07/24
NCT05060887 / 2021-002535-39: Immunogenicity and Safety of Three Dose Levels of OVX836 Candidate Vaccine Against Influenza in Healthy Volunteers.

Completed
2a
239
Europe
OVX836-003, Saline solution
Osivax, Center for vaccinology (CEVAC), University of Ghent
Influenza
02/22
12/22
2019-002939-28: A phase 2a, single center, randomized, observer blind, controlled study to evaluate the immunogenicity and the safety of one dose of OVX836 influenza vaccine at two dose levels (90 µg and 180 μg), in comparison to Influvac TetraTM, quadrivalent seasonal influenza sub-unit vaccine, after intramuscular administration in healthy subjects aged 18-65 years

Not yet recruiting
2
300
Europe
OVX836, Solution for injection
OSIVAX, Osivax
Healthy Volunteers (influenza Vaccine)Influenza infection is a major cause of respiratory disease that affects all age groups, leading to significant morbidity and mortality. Complications of influenza include otitis media, pneumonia, exarcerbations of chronic respiratory disease and bionchiolitis (in children) but also nonrespiratory complications such as febrile convulsions or myocarditis, Prevention of influenza disease irrespective of strains (seasonal and/or pandemic), Diseases [C] - Respiratory Tract Diseases [C08]
 
 
NCT05734040: Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects.

Completed
2
478
RoW
OVX836 480µg, Fluarix Tetra, Afluria Quad, Placebo
Osivax, Novotech (Australia) Pty Limited, Mater Misericordiae Limited
Influenza
08/23
01/24
NCT06582277: Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836

Completed
2
117
Europe
OVX836 shot
Osivax, Harmony Clinical Research BVBA, Clinfidence, Inferential, University Hospital, Ghent, KCAS Bio
Vaccine-Preventable Diseases, Influenza
06/25
06/25
VRC-MALMAB0100-00-AB / National Institute of Allergy and Infectious Diseases
NCT04329104: Safety and Efficacy of CIS43LS Anti-malaria mAb in Mali

Completed
2
348
RoW
VRC-MALMAB0100-00-AB (CIS43LS), Normal saline
National Institute of Allergy and Infectious Diseases (NIAID), Malaria Research and Training Center, Bamako, Mali, University of Washington, Harvard School of Public Health (HSPH)
Plasmodium Falciparum Infection, Malaria
01/22
07/23
oral live-attenuated Shigella sonnei vaccine (WRSs2) / National Institute of Allergy and Infectious Diseases
NCT04242264: Phase 2 Shigella Vaccine and Challenge

Completed
2
69
US
Placebo, Shigella sonnei strain 53G, WRSs2
National Institute of Allergy and Infectious Diseases (NIAID)
Immunisation, Shigella Infection
03/24
07/24
bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
UNITED, NCT04639479: At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19

Not yet recruiting
4
7500
NA
bamlanivimab
Daniel Griffin, MD PhD, Eli Lilly and Company, Optum, Inc.
Covid19
05/21
05/21
B-EPIC, NCT04796402: A Study to Assess if a Medicine Called Bamlanivimab is Safe and Effective in Reducing Hospitalization Due to COVID-19

Active, not recruiting
4
576
Canada
Bamlanivimab, Standard of Care
Fraser Health, Fraser Health Authrority Department of Evaluation and Research Services, Surrey Memorial Hospital Clinical Research Unit, Centre for Health Evaluation and Outcome Sciences, Surrey Hospital Foundation, BC Support Unit, University of British Columbia, Ministry of Health, British Columbia, Clinical Trials BC (part of the BC Academic Health Science Network)
Covid19
06/21
12/21
NCT05780268: LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Completed
3
314
Europe, US, RoW
LY3819253, Placebo, Remdesivir, Veklury
National Institute of Allergy and Infectious Diseases (NIAID), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Eli Lilly and Company, University of Minnesota
COVID-19
02/21
02/21
2021-002612-31: Adaptive, randomized, placebo-controlled trial to evaluate the efficacy of monoclonal antibodies in outpatients with mild or moderate COVID-19 (MANTICO) Studio clinico adattativo, randoMizzato, controllato con placebo, sull’uso di ANTIcorpi monoclonali nei pazienti affetti da forma lieve-moderata di COvid-19 (MANTICO)

Not yet recruiting
3
1260
Europe
Bamlanivimab, CASIRIVIMAB/IMDEVIMAB, ETESEVIMAB, [Bamlanivimab], [CASIRIVIMAB/IMDEVIMAB], [ETESEVIMAB], Concentrate for solution for injection/infusion, .
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA, AIFA - Italian Medicines Agency
COVID-19 COVID-19, COVID-19 COVID-19, Diseases [C] - Virus Diseases [C02]
 
 
TICO, NCT04501978 / 2020-003278-37: ACTIV-3: Therapeutics for Inpatients With COVID-19

Completed
3
2753
Europe, US, RoW
LY3819253, Placebo, Remdesivir, VIR-7831, BRII-196/BRII-198, AZD7442, AZD8895 + AZD1061, MP0420, ensovibep, PF-07304814
National Institute of Allergy and Infectious Diseases (NIAID), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Eli Lilly and Company, Vir Biotechnology, Inc., GlaxoSmithKline, Brii Biosciences Limited, AstraZeneca, Molecular Partners AG, Pfizer, University of Minnesota
Covid19
04/22
07/23
NCT04518410: ACTIV-2: A Study for Outpatients With COVID-19

Hourglass Jul 2022 - Dec 2022 : Data from ACTIV-2 trial for COVID-19
Hourglass May 2022 - Dec 2022 : Data from ACTIV-2 trial for the treatment of COVID-19
Checkmark Safety and efficacy data from ACTIV-2 P2/3 trial for the treatment for COVID-19
Jan 2022 - Jan 2022: Safety and efficacy data from ACTIV-2 P2/3 trial for the treatment for COVID-19
Checkmark Data from ACTIV-2 trial in combination with BRII-198 for COVID-19
More
Completed
2/3
4044
Canada, US, RoW
bamlanivimab 7000mg, LY3819253, BRII-196+BRII-198, AZD7442 (IV), AZD8895 + AZD1061, AZD7442 (IM), SNG001, Camostat, FOY-305, camostat mesilate, camostat mesylate, BMS-986414 + BMS-986413, C135-LS + C144-LS, SAB-185 (3,840 Units/kg), Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived), SAB-185 (10,240 Units/kg), CASIRIVIMAB + IMDEVIMAB, REGN10933 + REGN10987, REGN-COV2, Placebo for Bamlanivimab 7000mg, Placebo for Bamlanivimab 700mg, Placebo for BRII-196+BRII-198, Placebo for SNG001, Placebo for Camostat, Placebo for SAB-185 (low dose), Placebo for BMS-986414 + BMS-986413, Placebo for AZD7442 (IV), Placebo for AZD7442 (IM), Placebo for SAB-185 (high dose), bamlanivimab 700mg
National Institute of Allergy and Infectious Diseases (NIAID), Eli Lilly and Company, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, Brii Biosciences Limited, AstraZeneca, Sagent Pharmaceuticals, Synairgen Research Ltd., Bristol-Myers Squibb, SAb Biotherapeutics, Inc.
Coronavirus, Covid19
04/22
06/23
BLAZE-1, NCT04427501: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness

Completed
2/3
3307
US
LY3819253, LY-CoV555, Bamlanivimab, LY3832479, LY-CoV016, Etesevimab, LY3853113, bebtelovimab, Placebo
Eli Lilly and Company, AbCellera Biologics Inc., Shanghai Junshi Bioscience Co., Ltd.
COVID-19
02/23
02/23
NCT04840459: Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting

Recruiting
2
1000
US
BAMLANIVIMAB, CASIRIVIMAB, IMDEVIMAB
Sohail Rao
Covid19
12/22
01/23
NCT04603651: Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19

No Longer Available
N/A
NA
Bamlanivimab, LY3819253, LY-CoV555
Eli Lilly and Company, AbCellera Biologics Inc.
COVID-19
 
 
CONDIVIDIAMO, NCT05268601: COVID-19 and Disease Progression to the Severe Form: a Study on the Use of Monoclonal Antibodies Against SARS-CoV-2

Completed
N/A
251
Europe
Bamlanivimab, Bamlanivimab and Etesevimab Drug Combination, Casirivimab and Imdevimab Drug Combination, Sotrovimab
University of Milano Bicocca
COVID-19
12/23
12/23
Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
2022-000905-29: Temporal kinetics of antibody and cellular response markers and relative impact of revaccination in patients recovered from COVID-19 after treatment with monoclonal antibodies Cinetica tempoRale dei marcatori di risposta anticorpale e cEllulare e relativo impatto della rivacciNazione in pazienti guariti dalla COVID-19 dopo trattamento con anticoRpi monoclonali

Not yet recruiting
4
150
Europe
Evusheld, Xevudy, Comirnaty, Spikevax, Nuvaxovid, [-], Solution for injection, Concentrate for solution for infusion, Dispersion for injection, Evusheld, Xevudy, Comirnaty, Spikevax, Nuvaxovid
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
Covid-19 infection Infezione da Covid-19, Covid-19 infection Infezione da Covid-19, Diseases [C] - Virus Diseases [C02]
 
 
LUNAR, NCT05305651: Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19

Completed
4
217
Europe
Sotrovimab
GlaxoSmithKline
COVID-19
07/23
07/23
NCT05780281: VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Completed
3
367
Europe, US, RoW
VIR-7831, Placebo, Remdesivir, Veklury
National Institute of Allergy and Infectious Diseases (NIAID), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Vir Biotechnology, Inc., GlaxoSmithKline, University of Minnesota
COVID-19
06/21
10/22
2021-004188-28: A Phase III Randomized, Open-label, Multicenter Study to Determine the Safety and Efficacy of different MONoclonal Antibodies (MoAbs) to SARS-CoV-2 for the Early Treatment of COVID-19 in Non-hospitalized Adults Studio di fase 3, a braccio aperto, randomizzato di pazienti con un test per SARS-Cov-2 positivo documentato e sintomi lievi di COVID19, non ospedalizzati e reclutati in Italia. Questo studio valuta l’efficacia di anticorpi monoclonali multipli paragonati alla Standard of care (SOC) per il trattamento del Covid-19 in pazienti adulti non ospedalizzati

Not yet recruiting
3
1550
Europe
Imdevimab, Sotrovimab, Casirivimab, [-], Concentrate for solution for injection/infusion, Infusion, Concentrate for solution for infusion
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI", AIFA - Italian Medicines Agency
COVID-19 infection Infezione da COVID-19, COVID-19 infection Infezione da COVID-19, Diseases [C] - Virus Diseases [C02]
 
 
2021-004266-35: A multicenter clinical trial to compare the efficacy and safety of Casirivimab and Imdevimab or Bamlanivimab and Etesevimab or Sotrovimab in high risk COVID-19 hospital admission patients. Uno studio clinico multicentrico per confrontare l'efficacia e la sicurezza degli Anticorpi Monoclonali Casirivimab e Imdevimab o Bamlanivimab ed Etesevimab o Sotrovimab in pazienti domiciliari COVID-19 ad alto rischio di ricovero.

Ongoing
3
552
Europe
Casirivimab/imdevimab, Sotrovimab, Bamlanivimab/Etesevimab, [ronapreve], [VIR-7831], [Bamlanivimab/Etesevimab], Concentrate for solution for injection/infusion, Concentrate and solvent for solution for injection, casirivimab/imdevimab, Sotrovimab, Bamlanivimab/Etesevimab
AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA, AIFA - Italian Medicines Agency
Mild to moderate COVID-19 patients at high risk of progression to severe COVID-19 and / or hospitalization pazienti affetti da COVID-19 da lieve a moderato ad alto rischio di progressione a COVID-19 grave e/o ricovero ospedaliero, COVID-19 patients pazienti affetti da COVID-19, Diseases [C] - Virus Diseases [C02]
 
 
NCT04913675 / 2021-000623-13: Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.

Checkmark Efficacy and safety data from COMET-TAIL trial for early treatment of mild-to-moderate COVID-19
Nov 2021 - Nov 2021: Efficacy and safety data from COMET-TAIL trial for early treatment of mild-to-moderate COVID-19
Terminated
3
1065
Europe, US, RoW
sotrovimab, Sotrovimab
Vir Biotechnology, Inc., GlaxoSmithKline
Covid19
07/22
03/23
MANTICO 2, NCT05321394: Non-inferiority Trial on Treatments in Early COVID-19

Completed
3
536
Europe
Sotrovimab, Tixagevimab Cilgavimab, Nirmatrelvir Ritonavir
Azienda Ospedaliera Universitaria Integrata Verona, Agenzia Italiana del Farmaco, Azienda Sanitaria-Universitaria Integrata di Udine
COVID-19
10/23
10/23
RECOVERY, NCT04381936 / 2020-001113-21: Randomised Evaluation of COVID-19 Therapy

Checkmark Efficacy and safety data from RECOVERY trial in COVID-19
Jun 2021 - Jun 2021: Efficacy and safety data from RECOVERY trial in COVID-19
Recruiting
3
70000
Europe, RoW
Lopinavir-Ritonavir, Corticosteroid, Hydroxychloroquine, Azithromycin, Convalescent plasma, Tocilizumab, Immunoglobulin, Synthetic neutralising antibodies, REGEN-COV, casirivimab and imdevimab, Aspirin, Colchicine, Baricitinib, Anakinra, Dimethyl fumarate, High Dose Corticosteroid, Empagliflozin, Sotrovimab, Molnupiravir, Paxlovid, nirmatrelvir/ritonavir, Baloxavir Marboxil, Xofluza, Oseltamivir, Tamiflu, Low-dose corticosteroids: Dexamethasone
University of Oxford, UK Research and Innovation, National Institute for Health Research, United Kingdom, Wellcome, Bill and Melinda Gates Foundation, Department for International Development, United Kingdom, Health Data Research UK, Medical Research Council Population Health Research Unit, NIHR Clinical Trials Unit Support Funding, NIHR Health Protection Research Unit in Emerging and Zoonotic Infections, Flu Lab
Severe Acute Respiratory Syndrome
06/26
06/36
PROTECT-V, NCT04870333 / 2020-004144-28: PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V

Completed
2/3
2240
Europe
Niclosamide, Placebo, Ciclesonide, Sotrovimab
Cambridge University Hospitals NHS Foundation Trust, Life Arc, Kidney Research UK (KRUK), UNION therapeutics, Addenbrookes Charitable Trust, GlaxoSmithKline, National Institute for Health Research, United Kingdom
Covid19
04/25
04/25
COMET-ACE, NCT04766671: An Exploratory Study to Describe Virological Effect, Safety, and Pharmacokinetics of VIR-7831 Monoclonal Antibody in Hospitalized Participants With COVID-19

Not yet recruiting
2
150
NA
VIR-7831, Placebo, Standard of care
GlaxoSmithKline, Vir Biotechnology, Inc.
COVID-19
08/21
06/22
2021-006495-16: Immunogenicity and safety of Sotrovimab (Vir 7831) IV as primary prophylaxis in anti-SARS-CoV-2 vaccine non responders Immunogenicità e sicurezza di Sotrovimab (Vir 7831) IV come profilassi primaria nei non responders al vaccino anti-SARS-CoV-2

Not yet recruiting
2
100
Europe
Sotrovimab, [-], Infusion
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI", GlaxoSmithKline, VIR Biotechnology
Covid 19 Infection Infezione da Covid 19, Covid 19 Infection Infezione da Covid 19, Diseases [C] - Virus Diseases [C02]
 
 
NCT05210101: A Safety and Tolerability Study of Sotrovimab (VIR-7831) Prophylaxis Against COVID-19 in Immunocompromised Individuals

Completed
2
93
US
Sotrovimab, VIR-7831
Sophia Koo, M.D., Massachusetts General Hospital, Dana-Farber Cancer Institute, GlaxoSmithKline
SARS CoV 2 Infection
02/23
02/23
COMET-PACE, NCT05124210 / 2021-003717-18: Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19

Terminated
2
8
US
Sotrovimab
GlaxoSmithKline, Vir Biotechnology, Inc.
COVID-19
06/23
06/23
PLATCOV, NCT05041907: Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19

Recruiting
2
3800
RoW
Nirmatrelvir/ritonavir (e.g. PAXLOVID™), Nitazoxanide, Molnupiravir and nirmatrelvir/ritonavir (e.g. PAXLOVID™), Hydroxychloroquine, No treatment, Monoclonal antibodies, Fluoxetine, Molnupiravir, Sotrovimab, Ensitrelvir, Favipiravir, Ivermectin, Remdesivir, Atilotrelvir/ritonavir, Metformin, Nirmatrelvir/ritonavir, Nirmatrelvir
University of Oxford
COVID-19
01/27
01/27
NCT04746183: AGILE (Early Phase Platform Trial for COVID-19)

Hourglass Jan 2022 - Jun 2022 : Data from AGILE trial for COVID-19
Active, not recruiting
1/2
600
Europe, RoW
CST-2: EIDD-2801, MK-4482, Molnupiravir, CST-2: Placebo, Placebo, Nitazoxanide, VIR-7832, VIR-7831, Sotrovimab, CST-5: Placebo, Favipiravir, Lagevrio, Paxlovid, nirmatrelvir and ritonavir
University of Liverpool, University of Southampton, Liverpool School of Tropical Medicine, Liverpool University Hospitals NHS Foundation Trust, University of Cambridge
Covid19
07/25
07/25
COSMIC, NCT05280717: Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults

Terminated
1
316
US
sotrovimab
Vir Biotechnology, Inc., GlaxoSmithKline
Covid19
04/23
11/23
EHS-Strategy, NCT05144178: Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab )

Recruiting
N/A
3500
RoW
Emirates Health Services (EHS)
COVID-19 Respiratory Infection
01/22
02/22
NCT05235347: Sotrovimab Expanded Access Treatment Protocol (COVID-19)

No Longer Available
N/A
US
Sotrovimab
Vir Biotechnology, Inc.
Covid19
 
 
COVID-PR, NCT05013632: COVID-19 International Drug Pregnancy Registry

Recruiting
N/A
2000
US
Antiviral Agents, Veklury (remdesivir), Lagevrio (molnupiravir), Monoclonal antibody, REGEN-COV (casirivimab/imdevimab), Xevudy (sotrovimab)
Pregistry
Covid19
09/27
09/27
NCT05398718: Study on Sotrovimab and Its Impact on the Immune Response to COVID-19 Infection in Real-life in the UAE and Bahrain

Recruiting
N/A
20000
RoW
Sotrovimab
Abu Dhabi Health Services Company
COVID-19
12/22
12/22
TURN-COVID, NCT05195060: Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other Antiviral Agents Against SARS-CoV-2

Recruiting
N/A
1000
Europe
casirivimab with imdevimab, REGEN-COV, sotrovimab, Xevudy, molnupiravir, Lagevrio
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
COVID-19
06/24
06/24
CAP256V2LS / National Institute of Allergy and Infectious Diseases
NCT04408963: A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults

Completed
1
10
US
VRC-HIVMAB0102-00-AB, CAP256V2LS
National Institute of Allergy and Infectious Diseases (NIAID)
HIV
11/22
11/22
PGT121.414.LS / National Institute of Allergy and Infectious Diseases
HVTN143, NCT05959707: Evaluating the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies in Healthy Participants

Suspended
1
77
RoW
VRC01.23LS, PGT121.414.LS, PGDM1400LS
HIV Vaccine Trials Network, National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
01/25
01/25
zinlirvimab (GS-2872) / Gilead
2019-002129-31: The RIO Trial: A randomised placebo controlled trial of ART plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) vs ART plus placebo in treated Primary HIV Infection on viral control off ART

Not yet recruiting
2
72
Europe
3BNC117-LS, 10-1074-LS, 3BNC117-LS, 10-1074-LS, Solution for infusion
Imperial College London, Bill & Melinda Gates Foundation
HIV infection, HIV infection, Diseases [C] - Virus Diseases [C02]
 
 
RIO, NCT04319367 / 2019-002129-31: A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs).

Recruiting
2
72
Europe
Investigational Medicinal Product, 10-1074-LS and 3BNC117-LS
Imperial College London, Bill and Melinda Gates Foundation, University of Oxford, Rockefeller University
HIV/AIDS and Infections
07/27
07/27
 

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