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Ad26.RSV.preF-based vaccine
An adenovirus serotype 26 (Ad26)-based vaccine expressing the respiratory syncytial virus (RSV) prefusion F protein to elicit immune responses against RSV infection.
An adenovirus serotype 26 (Ad26)-based vaccine expressing the respiratory syncytial virus (RSV) prefusion F protein to elicit immune responses against RSV infection. Used for Prevention of respiratory syncytial virus (RSV) infection in adults, Prevention of RSV disease in older adults (≥60 years).
At a glance
| Generic name | Ad26.RSV.preF-based vaccine |
|---|---|
| Sponsor | Janssen Vaccines & Prevention B.V. |
| Drug class | Viral vector vaccine |
| Target | RSV prefusion F protein |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine uses a replication-incompetent Ad26 vector to deliver the RSV prefusion F (preF) protein, a key surface antigen of RSV. This stimulates both cellular and humoral immune responses, priming the immune system to recognize and neutralize RSV upon natural infection. The prefusion conformation of the F protein is thought to be more immunogenic and elicit more potent neutralizing antibodies compared to the postfusion form.
Approved indications
- Prevention of respiratory syncytial virus (RSV) infection in adults
- Prevention of RSV disease in older adults (≥60 years)
Common side effects
- Injection site pain or erythema
- Myalgia
- Fatigue
- Headache
- Fever
Key clinical trials
- 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 (PHASE3)
- 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 (PHASE3)
- A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years (PHASE3)
- 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 (PHASE3)
- A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults (PHASE2)
- 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 (PHASE2)
- A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old (PHASE3)
- 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 (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ad26.RSV.preF-based vaccine CI brief — competitive landscape report
- Ad26.RSV.preF-based vaccine updates RSS · CI watch RSS
- Janssen Vaccines & Prevention B.V. portfolio CI