Medigen Biotech News - LARVOL Sigma

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|||||||||| pfifteloxin (OBP-702) / Oncolys BioPharma, Telomelysin (suratadenoturev) / Oncolys BioPharma, Medigen Biotech
Journal, Oncolytic virus, Immunogenic cell death: p53-armed oncolytic virotherapy induces abscopal effect in osteosarcoma by promoting immunogenic cell death. (Pubmed Central) - Aug 7, 2024
Here, we show the

||||||||||  Telomelysin (suratadenoturev) / Oncolys BioPharma, Medigen Biotech
Enrollment closed, Surgery, Metastases:  NRG-GI007: Testing the Addition of the Anti-cancer Viral Therapy Telomelysin (clinicaltrials.gov) -  Aug 2, 2024
P1, N=16, Active, not recruiting,  Sponsor: NRG Oncology
Here, we show the Recruiting --> Active, not recruiting

|||||||||| TV003 / Medigen Biotech, National Institute of Allergy and Infectious Diseases
Journal: A pre-vaccination immune metabolic interplay determines the protective antibody response to a dengue virus vaccine. (Pubmed Central) - Jun 20, 2024
Systems vaccinology identifies a multi-OMICs pre-vaccination signature and mechanisms predictive of broad antibody responses after immunization with a tetravalent live attenuated DENV vaccine candidate (Butantan-DV/TV003)...The inhibition of viral sensing by PC/PE-induced TGF-? is confirmed in

|||||||||| Rituxan (rituximab) / Roche
MRNA VACCINES EXERT A BIPOLAR CLINICAL EFFECTIVENESS IN PATIENTS WITH RITUXIMAB-TREATED IMMUNE-MEDIATED INFLAMMATORY DISEASES OF VARYING DISEASE ACTIVITY STATUSES () - May 29, 2024 - Abstract #EULAR2024EULAR_3882;
is confirmed in Objectives: This study aims to explore the associations between the exposure mechanism of the SARS-CoV-2 vaccine and the outcomes of COVID-19 infection in IMID patients who have previously received RTX treatment...Using the National Immunization Information System (NIIS), the vaccination history of each patient was identified, and divided into three types: mRNA vaccines (BNT162b2/Pfizer

|||||||||| Journal: An Outline of the Immunogenic Potential of Progressing SARSCoV- 2 Vaccine Technologies among Children and Adolescents. (Pubmed Central) - Mar 30, 2024
Objectives: This study aims to explore the associations between the exposure mechanism of the SARS-CoV-2 vaccine and the outcomes of COVID-19 infection in IMID patients who have previously received RTX treatment...Using the National Immunization Information System (NIIS), the vaccination history of each patient was identified, and divided into three types: mRNA vaccines (BNT162b2/Pfizer Currently, the WHO is analyzing emerging evidence to issue an emergency use list of vaccines for vaccinating children and adolescents.

|||||||||| Biomarker, Journal: Temporal changes in biomarkers of neutrophil extracellular traps and NET-promoting autoantibodies following adenovirus-vectored, mRNA, and recombinant protein COVID-19 vaccination. (Pubmed Central) - Mar 25, 2024
The increased levels of citH3/MPO-DNA accompanied by NET-promoting autoantibodies suggest a potential connection between mRNA-1273/ChAdOx1-S vaccines and cardiovascular complications. These findings provide insights for risk assessments of future vaccines.

||||||||||  MVC-COV1901 / National Institutes of Health, Medigen Biotech, Spikevax (elasomeran) / Moderna
Trial completion:  A Heterologous Prime-boost Study to Evaluate Immunogenicity and Safety of mRNA-1273 With MVC-COV1901 in Adults (clinicaltrials.gov) -  Mar 22, 2024
P4, N=220, Completed,  Sponsor: National Taiwan University Hospital
These findings provide insights for risk assessments of future vaccines. Active, not recruiting --> Completed

|||||||||| ARB011 / Arbele
Pre-clinical development of ARB011: A CDH17 targeting allogeneic nonviral RNA-based "Flash" CAR-NK therapy for gastrointestinal cancer (Section 2) - Mar 5, 2024 - Abstract #AACR2024AACR_4200;
To generate the ARB011 CAR-NK cells, ex vivo expanded human peripheral blood NK (Magicell-NK, Medigen, Taiwan) cells were electroporated with mRNA encoding a humanized anti-CDH17 scFv fused with transactivation domains. Overall, the findings suggest that ARB011 could be a novel off-the-shelf, CAR-NK therapy that warrants further studies in animal models and in clinical trials.

|||||||||| Journal: Population-Based Evaluation of Vaccine Effectiveness against SARS-CoV-2 Infection, Severe Illness, and Death, Taiwan. (Pubmed Central) - Feb 26, 2024
We also found 95.8% VE against hospitalization for 3 doses of BNT162b2, 91.0% for MVC-COV1901, 81.8% for mRNA-1273, and 65.7% for AZD1222, which had the lowest overall VE. Our findings indicated that protein subunit vaccines provide similar protection against SARS-CoV-2---associated hospitalization as mRNA vaccines and can inform mix-and-match vaccine selection in other countries.

|||||||||| TV003 / Medigen Biotech, National Institute of Allergy and Infectious Diseases
EFFICACY AND SAFETY OF BUTANTAN-DV LIVE, ATTENUATED TETRAVALENT DENGUE VACCINE AND EPIDEMIOLOGICAL ANALYSES IN BRAZIL OVER AN AVERAGE OF 3.7 YEARS OF FOLLOW-UP (Hall C1M1) - Feb 9, 2024 - Abstract #ESPID2024ESPID_101;
P3
Background Butantan-DV is a live, attenuated tetravalent dengue vaccine analogous to TV003...Overall, different geographical regions experienced waves of VCD from DENV-1 and DENV-2 and no cases of DENV-3 or DENV-4 were observed through the follow-up. Conclusions/Learning Points A single dose of Butantan-DV was generally well tolerated and efficacious against DENV-1 and DENV-2 symptomatic VCD through an average 3.7 years of follow-up.

|||||||||| MVC-COV1901 / National Institutes of Health, Medigen Biotech
Journal, MRI: The application of cardiac MRI in Myocarditis after COVID-19 vaccines: Case series from single medical center in Taiwan. (Pubmed Central) - Feb 5, 2024
Cardiac MRI characterizes myocardial features such as edema, inflammation, and fibrosis, and has been proven to diagnose myocarditis accurately with a sensitivity of 87.5% and a specificity of 96.2% according to the 2018 Lake Louise criteria. This diagnosis was achieved without invasive procedures such as endomyocardial biopsy or coronary angiography.

|||||||||| TV003 / Medigen Biotech, National Institute of Allergy and Infectious Diseases, Dengvaxia (Dengue vaccine) / Sanofi
Journal, IO biomarker: Whole genome sequencing of outbreak strains from 2017-18 reveals an endemic clade of Dengue 1 virus in Cameroon. (Pubmed Central) - Nov 23, 2023
This diagnosis was achieved without invasive procedures such as endomyocardial biopsy or coronary angiography. Comparing our sequences to the vaccine strains, 19 and 15 amino acid (aa) substitutions were observed in the immuno-protective prM-E protein segments of the Dengvaxia

|||||||||| TV003 / Medigen Biotech, National Institute of Allergy and Infectious Diseases
Journal: Molecular Evolution of Dengue Virus 3 in Senegal between 2009 and 2022: Dispersal Patterns and Implications for Prevention and Therapeutic Countermeasures. (Pubmed Central) - Oct 28, 2023
Comparison of the amino acids in the CprM-E regions of genomes from the Senegalese strains against the vaccine strains revealed the presence of 22 substitutions (7 within the PrM and 15 within the E gene) when compared to CYD-3, while 23 changes were observed when compared to TV003 (6 within the PrM and 17 within the E gene)...Altogether, these data give up-to-date insight into DENV-3 genomic evolution in Senegal which needs to be taken into account in future vaccination strategies. Additionally, they highlight the importance of the genomic epidemiology of emerging pathogens in Africa and call for the implementation of a pan-African network for genomic surveillance of dengue virus.

||||||||||  MVC-COV1901 / National Institutes of Health, Medigen Biotech
Trial completion:  A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 in Adults Aged 18 Years and Above (clinicaltrials.gov) -  Oct 23, 2023
P3, N=250, Completed,  Sponsor: Medigen Vaccine Biologics Corp.
Additionally, they highlight the importance of the genomic epidemiology of emerging pathogens in Africa and call for the implementation of a pan-African network for genomic surveillance of dengue virus. Active, not recruiting --> Completed

||||||||||  MVC-COV1901 / National Institutes of Health, Medigen Biotech
Trial completion:  A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Vaccine Compared With AZD1222 (clinicaltrials.gov) -  Oct 23, 2023
P3, N=200, Completed,  Sponsor: Medigen Vaccine Biologics Corp.
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Telomelysin (suratadenoturev) / Oncolys BioPharma, Medigen Biotech
Trial completion date, Trial primary completion date, Surgery, Metastases:  NRG-GI007: Testing the Addition of the Anti-cancer Viral Therapy Telomelysin (clinicaltrials.gov) -  Oct 12, 2023
P1, N=16, Recruiting,  Sponsor: NRG Oncology
Active, not recruiting --> Completed Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2023 --> Oct 2024

|||||||||| TV003 / Medigen Biotech, National Institute of Allergy and Infectious Diseases, TDENV-PIV / GSK, U.S. Army Medical Research and Development Command, Dengvaxia (Dengue vaccine) / Sanofi
Review, Journal: Tracing down the Updates on Dengue Virus-Molecular Biology, Antivirals, and Vaccine Strategies. (Pubmed Central) - Aug 26, 2023
There is a need to put more effort into developing effective vaccines and therapeutics for dengue, as already approved vaccines and therapeutics have limitations. DENGVAXIA is approved for use in children and teenagers who are 6-16 years of age and have confirmed dengue infection, while Takeda is approved for use in certain countries, and it has withdrawn its application for FDA approval.

||||||||||  Telomelysin (suratadenoturev) / Oncolys BioPharma, Medigen Biotech
Enrollment open, Surgery, Metastases:  NRG-GI007: Testing the Addition of the Anti-cancer Viral Therapy Telomelysin (clinicaltrials.gov) -  Aug 9, 2023
P1, N=21, Recruiting,  Sponsor: NRG Oncology
DENGVAXIA is approved for use in children and teenagers who are 6-16 years of age and have confirmed dengue infection, while Takeda is approved for use in certain countries, and it has withdrawn its application for FDA approval. Active, not recruiting --> Recruiting

|||||||||| Journal: Risk reduction analysis of mix-and-match vaccination strategy in healthcare workers during SARS-CoV-2 Omicron variant predominant period: A multi-center cohort study in Taiwan. (Pubmed Central) - Aug 7, 2023
This study investigated the relative effectiveness of a mix-and-match vaccination strategy, primarily comprising ChAdOx1 nCOV-19, mRNA-1273, BNT162b2, and a protein-based vaccine, MVC-COV1901, against COVID-19 in a healthcare worker (HCW) cohort in Taiwan during a period when the Omicron variant was predominant...Secondly, for HCWs receiving an mRNA-1273 booster, compared to those receiving ChAdOx1 nCOV-19 as the primary series, mixed primary series and homologous mRNA-1273 primary series were associated with a higher (Adj HR 1.144; 95% CI 1.021?1.282, P?=?.021) and lower risk (Adj HR 0.735; 95% CI 0.671?0.805, P?<?.001) of acquiring infection, respectively. Our study demonstrated that mix-and-match vaccination strategy may be associated with different level of risk reduction in acquiring infection, and sizable, prospective studies are encouraged to further elucidate our observation.

|||||||||| MVC-COV1901 / National Institutes of Health, Medigen Biotech, Spikevax (elasomeran) / Moderna
Clinical, Journal: Immunogenicity and safety of heterologous mRNA-1273/MVC-COV1901 vaccination versus homologous mRNA1273 vaccination: A randomized, double-blind controlled study. (Pubmed Central) - Jun 16, 2023
P4
Our results show that heterologous boost with MVC-COV1901 yielded an inferior immunogenicity but significantly fewer adverse events, compared with homologous boost with mRNA-1273. In people experienced severe adverse events after prime dose of mRNA-1273, as well as in periods when the supply of mRNA-1273 is limited, MVC-COV1901 could serve as an acceptable alternative heterologous boost.

|||||||||| MVC-COV1901 / National Institutes of Health, Medigen Biotech, Vaxzevria (ChAdOx1-S recombinant) / University of Oxford, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, Spikevax (elasomeran) / Moderna
P2 data, Journal: Safety and immunogenicity of homologous versus heterologous booster dose with AZD1222, mRNA-1273, or MVC-COV1901 SARS-CoV-2 vaccines in adults: An observer-blinded, multi-center, phase 2 randomized trial. (Pubmed Central) - May 22, 2023
P2
Overall, MVC-COV1901 as a booster showed the best safety profiles. MVC-COV1901 as a primary series, with either homologous or heterologous booster, elicited the highest immunogenic response.

||||||||||  Telomelysin (suratadenoturev) / Oncolys BioPharma, Medigen Biotech
Enrollment closed, Enrollment change, Surgery, Metastases:  NRG-GI007: Testing the Addition of the Anti-cancer Viral Therapy Telomelysin (clinicaltrials.gov) -  May 15, 2023
P1, N=7, Active, not recruiting,  Sponsor: NRG Oncology
MVC-COV1901 as a primary series, with either homologous or heterologous booster, elicited the highest immunogenic response. Suspended --> Active, not recruiting | N=21 --> 7

|||||||||| Review, Journal: A dengue vaccine whirlwind update. (Pubmed Central) - Apr 28, 2023
While no specific treatments outside of supportive management exist, vaccines are an area of major research with two vaccines, Dengvaxia (CYD-TDV) and Denvax (TAK003), recently licensed for clinical use...Other vaccines including TV003 and TV005 continue to be developed across the world, with the hopes of entering clinical trials in the near future. We discuss the current state of vaccine development against dengue, with a focus on CYD-TDV and TAK003 as promising novel vaccines to target this neglected tropical disease (NTD).

||||||||||  Telomelysin (suratadenoturev) / Oncolys BioPharma, Medigen Biotech
Trial suspension, Surgery, Metastases:  NRG-GI007: Testing the Addition of the Anti-cancer Viral Therapy Telomelysin (clinicaltrials.gov) -  Apr 28, 2023
P1, N=21, Suspended,  Sponsor: NRG Oncology
We discuss the current state of vaccine development against dengue, with a focus on CYD-TDV and TAK003 as promising novel vaccines to target this neglected tropical disease (NTD). Recruiting --> Suspended

|||||||||| CDH17 CAR-NK cell therapy / Medigen Biotech, Magicell-NK / Medigen Biotech, CHM 2301 / Chimeric Therap
Development of allogenic nonviral RNA-based CAR-NK therapy targeting CDH17 in relapsed/refractory gastrointestinal cancer. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4595;
Ex vivo expanded human peripheral blood NK (Magicell-NK, Medigen, Taiwan) cells were used in this study. Our findings suggest that a non-viral based CDH17 CAR-NK cell therapy could be a potential allogeneic, off-the-shelf CAR-NK therapy candidate in GI cancer and support the rationale of further investigating it in vivo and clinical trials.

|||||||||| Observational data, Journal: Acute reactions after a homologous primary COVID-19 vaccination series: Analysis of Taiwan V-Watch data. (Pubmed Central) - Apr 19, 2023
Our findings suggest that a non-viral based CDH17 CAR-NK cell therapy could be a potential allogeneic, off-the-shelf CAR-NK therapy candidate in GI cancer and support the rationale of further investigating it in vivo and clinical trials. Acute reactogenicity and impact of work absenteeism for the four COVID vaccines in the V-Watch survey were mild and of short duration.

|||||||||| MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax, Vaxzevria (ChAdOx1-S recombinant) / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford, Spikevax (elasomeran) / Moderna
Journal, Real-world evidence, Real-world: Humoral and cellular immunity in three different types of COVID-19 vaccines against SARS-CoV-2 variants in a real-world data analysis. (Pubmed Central) - Apr 14, 2023
Acute reactogenicity and impact of work absenteeism for the four COVID vaccines in the V-Watch survey were mild and of short duration. This study compared memory T cells, total spike-binding antibody levels, and neutralizing capacity against WT, Delta, and Omicron variants between the MVC vaccine and the widely used Moderna and AZ vaccines, which provides valuable information for future vaccine development strategies.

|||||||||| adjuvant CpG 1018 / Dynavax, MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax, Vaxzevria (ChAdOx1-S recombinant) / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford
Journal, Benefit-risk assessment: A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Medigen COVID-19 protein vaccine. (Pubmed Central) - Apr 4, 2023
This article uses the BRAVATO template to review the features of the MVC-COV1901 vaccine, a recombinant protein subunit vaccine based on the stabilized pre-fusion SARS-CoV-2 spike protein S-2P, adjuvanted with CpG 1018 and aluminum hydroxide, manufactured by Medigen Vaccine Biologics Corporation in Taiwan...The main clinical trials include placebo-controlled phase 2 studies in healthy adults (CT-COV-21), adolescents (CT-COV-22), and elderly population (CT-COV-23) as well as 3 immunobridging phase 3 trials (CT-COV-31, CT-COV-32, and CT-COV-34) in which MVC-COV1901 was compared to AZD1222...Antigen-specific T-cell responses, particularly a Th1-biased immune response characterized by high levels of interferon gamma and IL-2 cytokines, have also been observed. Coupled with this, MVC-COV1901 has favorable thermostability and better safety profiles when compared to other authorized vaccines from different platforms, which make it potentially a good candidate for vaccine supply chains in global markets.

|||||||||| MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax, Vaxzevria (ChAdOx1-S recombinant) / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford, Spikevax (elasomeran) / Moderna
Journal: Neutralization of SARS-CoV-2 Omicron BA.1, BA.4, and BA.5 by primary ChAdOx1 nCoV-19, mRNA-1273, MVC-COV1901 and booster mRNA-1273 vaccination. (Pubmed Central) - Mar 29, 2023
Coupled with this, MVC-COV1901 has favorable thermostability and better safety profiles when compared to other authorized vaccines from different platforms, which make it potentially a good candidate for vaccine supply chains in global markets. No abstract available

||||||||||  MVC-COV1901 / National Institutes of Health, Medigen Biotech
Enrollment closed:  A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Vaccine Compared With AZD1222 (clinicaltrials.gov) -  Mar 15, 2023
P3, N=250, Active, not recruiting,  Sponsor: Medigen Vaccine Biologics Corp.
No abstract available Recruiting --> Active, not recruiting

||||||||||  MVC-COV1901 / National Institutes of Health, Medigen Biotech
Trial completion:  A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against COVID-19 (clinicaltrials.gov) -  Mar 15, 2023
P1, N=107, Completed,  Sponsor: Medigen Vaccine Biologics Corp.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax
Trial completion:  A Study to Evaluate the Safety and Immunogenicity of Booster With AZD1222, mRNA-1273, or MVC-COV1901 Against COVID-19 (clinicaltrials.gov) -  Mar 15, 2023
P2, N=804, Completed,  Sponsor: Medigen Vaccine Biologics Corp.
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| TV003 / Medigen Biotech, National Institute of Allergy and Infectious Diseases
EFFICACY AND SAFETY OF BUTANTAN-DV LIVE-ATTENUATED TETRAVALENT DENGUE VACCINE OVER TWO YEARS IN A PHASE 3 CLINICAL TRIAL (Auditorium VIII) - Feb 24, 2023 - Abstract #ESPID2023ESPID_274;
P3
Non-serious, solicited systemic vaccine-related AEs were observed in a slightly higher proportion of participants receiving Butantan-DV (58.3%) compared to placebo (45.6%) within 21 days postvaccination. The overall 2-year VE was 79.6% (95% CI:70.0%-86.3%).

|||||||||| TV003 / Medigen Biotech, National Institute of Allergy and Infectious Diseases
Journal, IO biomarker: The dengue virus 4 component of NIAID's tetravalent TV003 vaccine drives its innate immune signature. (Pubmed Central) - Feb 4, 2023
Finally, we found that the DEN-4Δ30 backbone in the DENV-2 component of the vaccine enhanced its antigenic properties, as evidenced by enhanced ability to induce IP-10 and IFNα2 in monocyte-derived dendritic cells. In sum, our study shows that the Δ30 and Δ30/Δ31 mutations attenuate the DENV vaccine strains in terms of replication and infectivity while still allowing the induction of a robust innate immune response.

|||||||||| muparfostat (PI-88) / Cellxpert Biotechnology Corp
Preclinical, Journal: The heparan sulfate mimetic Muparfostat aggravates steatohepatitis in obese mice due to its binding affinity to lipoprotein lipase. (Pubmed Central) - Feb 4, 2023
The binding activity to lipoprotein lipase of HS mimetics should be noted as an additional pharmacological effect during heparanase inhibitor drug discovery. This study also provides novel evidence for an increased risk of drug-induced liver injury in obese individuals.

|||||||||| MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax
Retrospective data, Journal: A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV. (Pubmed Central) - Jan 22, 2023
P2
Further investigations may be needed to determine whether PWH require distinct immunization strategies with improved immunogenicity. The main study is registered at ClinicalTrials.gov (NCT04695652).

||||||||||  TV003 / Medigen Biotech, National Institute of Allergy and Infectious Diseases
Enrollment closed:  Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine (clinicaltrials.gov) -  Jan 18, 2023
P3, N=16935, Active, not recruiting,  Sponsor: Butantan Institute
The main study is registered at ClinicalTrials.gov (NCT04695652). Recruiting --> Active, not recruiting

|||||||||| MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax
P2 data, Journal: Safety and immunogenicity of SARS-CoV-2 vaccine MVC-COV1901 in Taiwanese adolescents: a randomized phase 2 trial. (Pubmed Central) - Dec 18, 2022
P2
MVC-COV1901 is a subunit SARS-CoV-2 vaccine based on stabilized spike protein adjuvanted with CpG 1018 and aluminum hydroxide that has received emergency use approval (EUA) for adults in Taiwan...All immunogenicity endpoints in the adolescent group were non-inferior to the endpoints seen in the young adult and placebo groups. The results here advocate the use of MVC-COV1901 in adolescents in the ongoing efforts to control the pandemic.ClinicalTrials.gov registration: NCT04951388.

|||||||||| Journal: Serological responses triggered by different SARS-CoV-2 vaccines against SARS-CoV-2 variants in Taiwan. (Pubmed Central) - Dec 3, 2022
We collected sera samples between December 2021-January 2022 from 113 Taiwan naïve participants after their second dose of homologous vaccine (AZD1222, mRNA-1273, BNT162-b2, and MVC-COV1901) and compared the differences in serological responses of various SARS-CoV-2 vaccines...These results suggested that constantly administering the vaccine with ancestral Wuhan spike is insufficient for the Omicron outbreak. In addition, we found that anti-ACE2 autoantibodies were significantly increased in all four vaccinated groups compared to the unvaccinated pre-pandemic group, which needed to be investigated in the future.

||||||||||  TV003 / Medigen Biotech, National Institute of Allergy and Infectious Diseases
Enrollment open, Trial completion date, Trial primary completion date:  Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine (clinicaltrials.gov) -  Nov 30, 2022
P3, N=16944, Recruiting,  Sponsor: Butantan Institute
In addition, we found that anti-ACE2 autoantibodies were significantly increased in all four vaccinated groups compared to the unvaccinated pre-pandemic group, which needed to be investigated in the future. Active, not recruiting --> Recruiting | Trial completion date: Aug 2024 --> Nov 2024 | Trial primary completion date: Aug 2021 --> Dec 2022

|||||||||| MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax
Clinical, P3 data, P3 data: top line, Journal: An evaluation of the safety and immunogenicity of MVC-COV1901: Results of an interim analysis of a phase III, parallel group, randomized, double-blind, active-controlled immunobridging study in Paraguay. (Pubmed Central) - Nov 22, 2022
Safety and immunogenicity data of MVC-COV1901 from the study in Paraguay confirm previous results. The previous infection coupled with vaccination of this vaccine may offer protection against the Omicron strain though its durability is still unknown.

|||||||||| Vaxzevria (ChAdOx1-S recombinant) / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford
Clinical, Journal: Titers and breadth of neutralizing antibodies against SARS-CoV-2 variants after heterologous booster vaccination in health care workers primed with two doses of ChAdOx1 nCov-19: A single-blinded, randomized clinical trial. (Pubmed Central) - Nov 19, 2022
Third dose booster not only increases neutralizing antibody titer but also enhances antibody breadth against SARS-CoV-2 variants. mRNA vaccines are preferred booster vaccines for those who received primary series of ChAdOx1 nCov-19.

||||||||||  Telomelysin (suratadenoturev) / Oncolys BioPharma, Medigen Biotech
Trial primary completion date, Surgery, Metastases:  NRG-GI007: Testing the Addition of the Anti-cancer Viral Therapy Telomelysin (clinicaltrials.gov) -  Nov 14, 2022
P1, N=21, Recruiting,  Sponsor: NRG Oncology
mRNA vaccines are preferred booster vaccines for those who received primary series of ChAdOx1 nCov-19. Trial primary completion date: Oct 2022 --> Oct 2023

|||||||||| MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax
Journal: Protection of Hamsters Challenged with SARS-CoV-2 Delta Variant after Two Doses of Adjuvanted SARS-CoV-2 Stabilized Prefusion Spike Protein (S-2P) and a Single Dose of Beta Variant S-2P. (Pubmed Central) - Nov 4, 2022
Compared to three doses of W S-2P, two doses of W S-2P followed by a third dose of B S-2P induced the highest neutralizing antibody titer against live SARS-CoV-2 virus and enhanced neutralization of Omicron variant pseudovirus. Reduced lung live virus titer and pathology suggested that all vaccination regimens protect hamsters from SARS-CoV-2 Delta variant challenge.

|||||||||| MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax
P2 data, Journal: Safety and Immunogenicity of MVC-COV1901 Vaccine in Older Adults: Phase 2 Randomized Dose-Comparison Trial. (Pubmed Central) - Nov 2, 2022
P2
Given the general population-associated safety and immunogenicity of MVC-COV1901, we recommend high dose for immunization of elder adults with MVC-COV1901. The clinical trial was registered at https://clinicaltrials.gov/ (NCT04822025).

|||||||||| MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax
Journal: Boosting with Multiple Doses of mRNA Vaccine after Priming with Two Doses of Protein Subunit Vaccine MVC-COV1901 Elicited Robust Humoral and Cellular Immune Responses against Emerging SARS-CoV-2 Variants. (Pubmed Central) - Oct 29, 2022
However, the Omicron variant showed strong immune evasion ability for all vaccination schedules. Our findings provided evidence supporting that heterologous vaccination by boosting with mRNA vaccine after priming with two doses of protein subunit vaccine could strongly promote humoral and cellular immune responses against the emerging SARS-CoV-2 variants.

|||||||||| MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax, Vaxzevria (ChAdOx1-S recombinant) / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford
Journal: Safety and Immunogenicity of a Heterologous Booster of Protein Subunit Vaccine MVC-COV1901 after Two Doses of Adenoviral Vector Vaccine AZD1222. (Pubmed Central) - Oct 28, 2022
These results support the use of MVC-COV1901 as a heterologous booster for individuals vaccinated with AZD1222. Furthermore, regardless of the dosing schedule, the combination of AZD1222 primary series and MVC-COV1901 booster can be cost-effective and suitably applied to low- and middle-income countries (LMIC).

|||||||||| Evolution of anti-SARS-CoV-2 spike protein titers after two-dose COVID-19 vaccination among people living with HIV (Virtual) - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_367;
Two doses of homologous mRNA vaccination had significantly higher immunogenicity than vaccination with AZD1222 or MVC-COV1901 among PLWHIV. PLWHIV with CD4 count <200 cells/mm3 had consistently lower antibody responses with either mRNA or non-mRNA vaccination.

|||||||||| Journal: Immunogenicity and safety of two-dose SARS-CoV-2 vaccination via different platforms in kidney transplantation recipients. (Pubmed Central) - Oct 4, 2022
Four vaccines, including one viral vector (ChAdOx1 nCov-19, n = 30), two mRNA (mRNA1273, n = 81 and BNT162b2, n = 38), and one protein subunit (MVC-COV1901, n = 22) vaccines were administered...In conclusion, mRNA1273 had better immunogenicity than the other vaccines. Further, renal function needs to be carefully monitored after vaccination, and vaccination strategies should be tailored according to the transplant status and vaccine characteristics.

||||||||||  MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax
Trial completion:  A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 Against COVID-19 in Adults (clinicaltrials.gov) -  Sep 30, 2022
P3, N=1030, Completed,  Sponsor: Medigen Vaccine Biologics Corp.
Further, renal function needs to be carefully monitored after vaccination, and vaccination strategies should be tailored according to the transplant status and vaccine characteristics. Active, not recruiting --> Completed



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