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- || VAC18193 / J&J
Clinical, P2a data, Journal: Immunogenicity and safety of different dose levels of Ad26.RSV.preF/RSV preF protein vaccine in adults aged 60 (Pubmed Central) - Sep 15, 2024
P2
Results of this dose-ranging study may be used to inform the refinement of Ad26.RSV.preF drug product release and stability specifications.
- || VAC18193 / J&J
P1/2 data, Journal: A Phase 1/2a Study Evaluating Safety and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers Aged 12-24 Months. (Pubmed Central) - Sep 2, 2024
P1/2
Results of this dose-ranging study may be used to inform the refinement of Ad26.RSV.preF drug product release and stability specifications. In this randomized, observer-blinded, placebo-controlled, phase 1/2a study (NCT03606512; https://www.clinicaltrials.gov/ct2/show/NCT03606512), RSV-seronegative toddlers aged 12-24 months received Ad26.RSV.preF (2.5
- || VAC18193 / J&J
P2b data, Journal: Long-term efficacy and immunogenicity of Ad26.RSV.preF-RSV preF protein vaccine (CYPRESS): a randomised, double-blind, placebo-controlled, phase 2b study. (Pubmed Central) - Aug 24, 2024
P2
In this randomized, observer-blinded, placebo-controlled, phase 1/2a study (NCT03606512; https://www.clinicaltrials.gov/ct2/show/NCT03606512), RSV-seronegative toddlers aged 12-24 months received Ad26.RSV.preF (2.5 Ad26.RSV.preF-RSV preF protein maintained high efficacy against RSV LRTD in older adults across three RSV seasons.
- | VAC18193 / J&J
Journal, Head-to-Head: Concomitant Administration of Ad26.RSV.preF/RSV preF Protein Vaccine and High-dose Influenza Vaccine in Adults 65 Years and Older: a Noninferiority Trial. (Pubmed Central) - Aug 15, 2024
Ad26.RSV.preF-RSV preF protein maintained high efficacy against RSV LRTD in older adults across three RSV seasons. Coadministration of Ad26.RSV.preF/RSV preF protein and Fluzone-HD showed an acceptable safety profile and did not hamper the immunogenicity of either vaccine, thus supporting that both vaccines can be concomitantly administered in adults ?65 years old.
- || VAC18193 / J&J
Clinical, Clinical Trial,Phase I, Journal: Immunogenicity and safety of Ad26.RSV.preF/RSV preF protein vaccine at predicted intermediate- and end-of-shelf-life as an evaluation of potency throughout shelf life. (Pubmed Central) - May 24, 2024
The study provided evidence of sustained immunogenicity and safety over the intended shelf-life of the Ad26.RSV.pref/RSV preF protein vaccine. The three vaccine lots had acceptable safety profiles.
- |||||| VAC18193 / J&J
Phase classification, Trial termination: CYPRESS: A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older (clinicaltrials.gov) - May 16, 2024
P2, N=5815, Terminated, Sponsor: Janssen Vaccines & Prevention B.V.
The three vaccine lots had acceptable safety profiles. Phase classification: P2b --> P2 | Completed --> Terminated; The study was terminated early by the sponsor due to strategic reprioritization reasons.
- || VAC18193 / J&J
Clinical, P1/2 data, Journal: Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. (Pubmed Central) - Jan 15, 2024
P1/2
Clinical Trials Registration. NCT03502707.
- | VAC18193 / J&J
Phase classification: A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults (clinicaltrials.gov) - Jan 9, 2024
P2, N=459, Completed, Sponsor: Janssen Vaccines & Prevention B.V.
NCT03502707. Phase classification: P2a --> P2
- ||||||| VAC18193 / J&J
Trial completion: EVERGREEN: A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older (clinicaltrials.gov) - Nov 9, 2023
P3, N=25236, Completed, Sponsor: Janssen Vaccines & Prevention B.V.
Phase classification: P2a --> P2 Active, not recruiting --> Completed
- | VAC18193 / J&J
Journal: Vaccine-induced antibody Fc-effector functions in humans immunized with a combination Ad26.RSV.preF/RSV preF protein vaccine. (Pubmed Central) - Oct 30, 2023
In this work, we show that the investigational Ad26.RSV.preF/RSV preF protein vaccine induced Fc-effector functional immune responses in adults aged ?60 years who were enrolled in a phase 1/2a regimen selection study of Ad26.RSV.preF/RSV preF protein. These results demonstrate the breadth of the immune responses induced by the Ad26.RSV.preF/RSV preF protein vaccine.
- |||| VAC18193 / J&J
Trial completion date, Trial primary completion date: EVERGREEN: A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older (clinicaltrials.gov) - Oct 11, 2023
P3, N=25236, Active, not recruiting, Sponsor: Janssen Vaccines & Prevention B.V.
These results demonstrate the breadth of the immune responses induced by the Ad26.RSV.preF/RSV preF protein vaccine. Trial completion date: Nov 2024 --> Oct 2023 | Trial primary completion date: Oct 2024 --> Jul 2023
- |||| VAC18193 / J&J
Trial completion, Trial completion date: CYPRESS: A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older (clinicaltrials.gov) - Jul 27, 2023
P2b, N=5815, Completed, Sponsor: Janssen Vaccines & Prevention B.V.
Trial completion date: Nov 2024 --> Oct 2023 | Trial primary completion date: Oct 2024 --> Jul 2023 Active, not recruiting --> Completed | Trial completion date: May 2024 --> May 2023
- ||||| VAC18193 / J&J
Enrollment closed: EVERGREEN: A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older (clinicaltrials.gov) - Jun 29, 2023
P3, N=25253, Active, not recruiting, Sponsor: Janssen Vaccines & Prevention B.V.
Active, not recruiting --> Completed | Trial completion date: May 2024 --> May 2023 Recruiting --> Active, not recruiting
- | VAC18193 / J&J
Journal: In older adults, an Ad26.RSV.preF-RSV preF protein vaccine reduced RSV-related lower respiratory tract disease. (Pubmed Central) - Jun 5, 2023
2023;388:609-620. 36791161.
- ||||||||| VAC18193 / J&J
Trial termination: A Study of Adenovirus Serotype 26.Respiratory Syncytial Virus.Pre-Fusion F (Ad26.RSV.preF)-Based Vaccine for Prevention of Respiratory Syncytial Virus (RSV) Mediated- Lower Respiratory Tract Disease (LRTD) in Japanese Participants (clinicaltrials.gov) - May 19, 2023
P3, N=2192, Terminated, Sponsor: Janssen Pharmaceutical K.K.
Recruiting --> Terminated; Terminated (Janssen made the strategic decision to discontinue the RSV3007 study. This decision is not based on any safety concerns.)
- | VAC18193 / J&J
Preclinical, Journal: Combination Ad26.RSV.preF/preF protein vaccine induces superior protective immunity compared with individual vaccine components in preclinical models. (Pubmed Central) - Mar 25, 2023
Immunization with the combination elicited superior protection against RSV A2 challenge in cotton rats. These results demonstrate the advantage of a combination vaccine and support further clinical development.
- VAC18193 / J&J
Immunogenicity and safety of Ad26.RSV.preF/RSV preF protein vaccine co-administered with a seasonal influenza vaccine in older adults (Poster Area) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_4518;
- mRNA-1345 / Moderna
Safety and efficacy of a respiratory syncytial virus vaccine (mRNA-1345), against a spectrum of symptomatic disease in adults aged ?60 years (C / 07) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_1014;
- ||| respiratory syncytial virus (RSV) vaccine (GSK3389245A) / GSK, VAC18193 / J&J
13/ #MedTwitter Carrier viral vectors used for #RSV antigen transport include: ✔️Modified vaccinia Ankara (MVA) virus ✔️Parainfluenza virus type 3 (PIV3) 🚩Sendai virus vectored RSV (seVRSV) ✔️Simian Adenovirus (Pan AD3) ✔️Adenovirus (serotype 5) 🚩Ad26.RSV.Pre-F, ChAD155-RSV (Twitter) - Nov 22, 2022
- |||| VAC18193 / J&J
Trial primary completion date: EVERGREEN: A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older (clinicaltrials.gov) - Nov 18, 2022
P3, N=27200, Recruiting, Sponsor: Janssen Vaccines & Prevention B.V.
These results demonstrate the advantage of a combination vaccine and support further clinical development. Trial primary completion date: Jun 2023 --> Oct 2024
- || VAC18193 / J&J
7/ 🔴 Post-Poll 4️⃣ #BonumCE #MedTwitter 🟠#CME💡 https://t.co/XQLFtR1ij6 🔴 In the Ad26.RSV.preF CYPRESS trial (which utilized single dosing over multiple seasons); durability of response across 3⃣ #RSV seasons prevented what percentage of RSV-related LRTD? (Twitter) - Nov 14, 2022
- || VAC18193 / J&J
2/🟢Pre-Poll2️⃣ #BonumCE #MedTwitter 🟠#CME👉 https://t.co/SX5T0JvAiz 🟢In the Ad26.RSV.preF CYPRESS trial (which utilized single dosing over multiple seasons); durability of response across 3⃣ #RSV seasons prevented what percentage of RSV-related LRTD? (Twitter) - Nov 11, 2022
- |||| VAC18193 / J&J
Clinical: 30/ #BonumCE #IDMedEd #IDTwitter #RSV #CME 👉🔗https://t.co/vUW1qocnKc 🔴Post Poll # 3⃣ 🔴The overall efficacy of the Ad26.RSV.preF #vaccine for ≥3 sx in the CYPRESS Study was: (Twitter) - Nov 10, 2022
- ||| MVA-BN RSV / Bavarian Nordic, VAC18193 / J&J
Clinical: 27/SUMMARY 🔑Ad26.RSV.preF-base💉well-tolerated & highly effective against RSV-mediated LRTD (even w/o an adjuvant) 🔑Stimulated strong, durable humoral & cellular immune RSV-specific response in adults ≥65y after 1️⃣dose 🔑MVA-BN RSV💉efficacy of 79.3% in HCT; adv to ph3 trials (Twitter) - Nov 10, 2022
- |||| VAC18193 / J&J
Clinical, P2b data: 21/ CYPRESS: RCT, DB, PBO-controlled Phase 2b trial Ad26.RSV.preF-based vaccine 🧩5782 Adults ≥65y of age were randomized 1:1 prior to the #RSV season 🧩Sx of ARI collected 🧩LRTI occurrence by 3 case defn 🧩Immunogenicity assessments #MedTwitter #IDTwitter #IDMedEd (Twitter) - Nov 10, 2022
- ||| VAC18193 / J&J
20/Pre-F specific sites🎯by neutralizing antibodies 📍Ad26.RSV.preF💉led to an⬆️ in pre-F & post-F IgG serum antibody response & RSV A2 neutralizing antibody titers vs PBO 📍Pre-existing Ad26 neutralizing antibodies📏@ BL did not impact💉induced immune responses #RSV #BonumCE (Twitter) - Nov 10, 2022
- ||||| VAC18193 / J&J
Clinical, P2a data: 19/ Phase 2a DB RCT intranasal challenge in healthy adults aged 18-50y randomized 1:1 to receive 1x1011 vp Ad26.RSV.preF💉or PBO, IM 💪Post challenge results💪 VL, RSV infections & dx severity🔽in Ad26.RSV.preF (n=27) vs PBO (n=26) ⭐primary endpoint met⭐️ #RSV #MedTwitter (Twitter) - Nov 10, 2022
- |||| VAC18193 / J&J
Clinical: 18/ #RSV #MedTwitter #IDTwitter #IDMedEd #pulmtwitter #BonumCE 🟢 The overall efficacy of the Ad26.RSV.preF #vaccine for ≥3 sx in the CYPRESS study was: (Twitter) - Nov 10, 2022
- |||| VAC18193 / J&J
Clinical: 17/ Ad26.RSV.preF is a recombinant adeno🦠serotype 26 vector (Ad26) vaccine ⛓️Encodes for a full-length, stabilized pre-RSV-F protein expressed on the cell surface 🔬In clinical trials to assess🤺protection against #RSV infection & disease #MedTwitter #IDTwitter #IDMedEd (Twitter) - Nov 10, 2022
- ||||||| VAC18193 / J&J
Trial completion: A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years (clinicaltrials.gov) - Oct 26, 2022
P3, N=755, Completed, Sponsor: Janssen Vaccines & Prevention B.V.
Trial primary completion date: Jun 2023 --> Oct 2024 Active, not recruiting --> Completed
- |||| VAC18193 / J&J
Trial completion: A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old (clinicaltrials.gov) - Oct 26, 2022
P2b, N=250, Completed, Sponsor: Janssen Vaccines & Prevention B.V.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||||| VAC18193 / J&J
Trial completion: A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older (clinicaltrials.gov) - Oct 26, 2022
P3, N=777, Completed, Sponsor: Janssen Vaccines & Prevention B.V.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || VAC18193 / J&J
Clinical, P1/2 data, Journal: Phase 1/2a Safety and Immunogenicity of an Adenovirus 26 Vector RSV Vaccine Encoding Prefusion F in Adults 18-50 Years and RSV Seropositive Children 12-24 Months. (Pubmed Central) - Oct 20, 2022
Ad26.RSV.preF demonstrated immunogenicity in healthy adults and toddlers, with no safety concerns raised. Evaluations in RSV-seronegative children are underway.
- VAC18193 / J&J
Ad26.RSV.preF completely protects calves from severe respiratory disease induced by bovine RSV challenge (POSTER BOARD NO. 152) - Oct 4, 2022 - Abstract #ISIRVRSV2022ISIRV_RSV_244;
- VAC18193 / J&J
Vaccine-induced antibody Fc-effector functions in humans immunized with a combination Ad26.RSV.preF/RSV preF protein vaccine (POSTER BOARD NO. 9) - Oct 4, 2022 - Abstract #ISIRVRSV2022ISIRV_RSV_124;
- VAC18193 / J&J
Efficacy of Ad26.RSV.preF/RSV preF protein vaccine against RSV in a phase 2b study of adults aged ≥65 years over 3 seasons (Hall 1A) - Sep 30, 2022 - Abstract #ISIRVRSV2022ISIRV_RSV_107;
P2b
Evaluations in RSV-seronegative children are underway. Data from CYPRESS support that a single dose of the Ad26.RSV.preF/RSV preF protein vaccine is efficacious against RSV LRTD and any RSV ARI through at least 3 RSV seasons in adults aged ≥65 years.
- ||| VAC18193 / J&J
Trial completion date: EVERGREEN: A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older (clinicaltrials.gov) - Sep 28, 2022
P3, N=27500, Recruiting, Sponsor: Janssen Vaccines & Prevention B.V.
Data from CYPRESS support that a single dose of the Ad26.RSV.preF/RSV preF protein vaccine is efficacious against RSV LRTD and any RSV ARI through at least 3 RSV seasons in adults aged ≥65 years. Trial completion date: Oct 2023 --> Nov 2024
- ||||||| VAC18193 / J&J
Trial completion: A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection (clinicaltrials.gov) - Sep 28, 2022
P3, N=1124, Completed, Sponsor: Janssen Vaccines & Prevention B.V.
Trial completion date: Oct 2023 --> Nov 2024 Recruiting --> Completed
- VAC18193 / J&J
Long-term immunogenicity of Ad26.RSV.preF/RSV preF protein vaccine against RSV in a phase 2b study by age and risk level (144 ABC) - Sep 8, 2022 - Abstract #IDWeek2022IDWEEK_2660;
- VAC18193 / J&J
Exploring the Potential Public Health Benefits of a Respiratory Syncytial Virus (RSV) Vaccine Candidate (Ad26.RSV.preF/RSV) Among Individuals Aged 65 Years and Older in the UK: A Preliminary Mathematical Modelling Approach (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_913;
If confirmed, the programme could be an important public health intervention in alleviating undue pressures on the NHS during RSV seasons. Timely policy for the use of RSV adult vaccines as they become licensed for use and available could be critical.
- || Ad26.RSV.preF / J&J
Clinical, Journal: Prevention of Respiratory Syncytial Virus Infection in Healthy Adults by a Single Immunization of Ad26.RSV.preF in a Human Challenge Study. (Pubmed Central) - Aug 31, 2022
P2, P2a
Timely policy for the use of RSV adult vaccines as they become licensed for use and available could be critical. Ad26.RSV.preF demonstrated protection from RSV infection through immunization in a human challenge model, and therefore could potentially protect against natural RSV infection and disease.
- |||| VAC18193 / J&J
Trial completion: A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older (clinicaltrials.gov) - Aug 3, 2022
P1/2, N=669, Completed, Sponsor: Janssen Vaccines & Prevention B.V.
Ad26.RSV.preF demonstrated protection from RSV infection through immunization in a human challenge model, and therefore could potentially protect against natural RSV infection and disease. Active, not recruiting --> Completed
- VAC18193 / J&J
Long term (2-year) immunogenicity of a combination Ad26.RSV.preF/RSV preF protein vaccine evaluated in a phase 1/2a study (Hall 1A) - Aug 1, 2022 - Abstract #ISIRVRSV2022ISIRV_RSV_54;
- ||||| VAC18193 / J&J
Trial initiation date: EVERGREEN: A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older (clinicaltrials.gov) - May 11, 2022
P3, N=27500, Recruiting, Sponsor: Janssen Vaccines & Prevention B.V.
Active, not recruiting --> Completed Initiation date: Jul 2021 --> Feb 2021
- ||||| VAC18193 / J&J
Enrollment closed: A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older (clinicaltrials.gov) - May 11, 2022
P3, N=777, Active, not recruiting, Sponsor: Janssen Vaccines & Prevention B.V.
Initiation date: Jul 2021 --> Feb 2021 Recruiting --> Active, not recruiting
- |||||| VAC18193 / J&J
Enrollment open: A Study of Adenovirus Serotype 26.Respiratory Syncytial Virus.Pre-Fusion F (Ad26.RSV.preF)-Based Vaccine for Prevention of Respiratory Syncytial Virus (RSV) Mediated- Lower Respiratory Tract Disease (LRTD) in Japanese Participants (clinicaltrials.gov) - Apr 25, 2022
P3, N=2180, Recruiting, Sponsor: Janssen Pharmaceutical K.K.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||||| VAC18193 / J&J
Enrollment closed: A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years (clinicaltrials.gov) - Apr 12, 2022
P3, N=755, Active, not recruiting, Sponsor: Janssen Vaccines & Prevention B.V.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- ||| VAC18193 / J&J
Enrollment closed: A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old (clinicaltrials.gov) - Mar 16, 2022
P2b, N=250, Active, not recruiting, Sponsor: Janssen Vaccines & Prevention B.V.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- | Ad26.RSV.preF / J&J
Preclinical, Journal: Immunogenicity and protective efficacy of adenoviral and subunit RSV vaccines based on stabilized prefusion F protein in pre-clinical models. (Pubmed Central) - Mar 11, 2022
Factors that may contribute to the protective capacity of Ad26.RSV.preF elicited immunity are the induced IgG2a antibodies that are able to engage Fcγ receptors mediating Antibody Dependent Cellular Cytotoxicity (ADCC), and the induction of systemic and lung resident RSV specific CD8 + T cells. These data demonstrate qualitative improvement of immune responses elicited by an adenoviral vector based vaccine encoding the RSV preF antigen compared to the subunit vaccine in small animal models which may inform RSV vaccine development.
- |||| VAC18193 / J&J
Trial primary completion date: A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older (clinicaltrials.gov) - Feb 23, 2022
P3, N=750, Recruiting, Sponsor: Janssen Vaccines & Prevention B.V.
These data demonstrate qualitative improvement of immune responses elicited by an adenoviral vector based vaccine encoding the RSV preF antigen compared to the subunit vaccine in small animal models which may inform RSV vaccine development. Trial primary completion date: Dec 2021 --> Sep 2022