{"id":"ad26-rsv-pref-based-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain or erythema"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"}]},"_chembl":{"chemblId":"CHEMBL5314975","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"An adenovirus serotype 26 (Ad26)-based vaccine expressing the respiratory syncytial virus (RSV) prefusion F protein to elicit immune responses against RSV infection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:59:28.284Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of respiratory syncytial virus (RSV) infection in adults"},{"name":"Prevention of RSV disease in older adults (≥60 years)"}]},"trialDetails":[{"nctId":"NCT04908683","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2021-07-21","conditions":"Respiratory Syncytial Viruses, Lower Respiratory Tract Disease","enrollment":25236},{"nctId":"NCT05070546","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2021-09-29","conditions":"Respiratory Syncytial Virus Infection Prevention","enrollment":1124},{"nctId":"NCT05101486","phase":"PHASE3","title":"A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2021-11-01","conditions":"Respiratory Syncytial Virus Prevention","enrollment":755},{"nctId":"NCT05071313","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2021-10-04","conditions":"Influenza, Human Prevention, Respiratory Syncytial Viruses Prevention","enrollment":777},{"nctId":"NCT04453202","phase":"PHASE2","title":"A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2020-07-16","conditions":"Healthy","enrollment":459},{"nctId":"NCT03982199","phase":"PHASE2","title":"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","status":"TERMINATED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2019-08-01","conditions":"Respiratory Syncytial Viruses, Respiratory Tract Diseases","enrollment":5815},{"nctId":"NCT05083585","phase":"PHASE3","title":"A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2021-10-08","conditions":"Respiratory Syncytial Virus Prevention","enrollment":250},{"nctId":"NCT05242432","phase":"PHASE3","title":"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","status":"TERMINATED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2022-04-01","conditions":"Respiratory Syncytial Virus Prevention","enrollment":2192},{"nctId":"NCT03606512","phase":"PHASE1, PHASE2","title":"A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2019-01-21","conditions":"Respiratory Syncytial Virus","enrollment":38},{"nctId":"NCT03339713","phase":"PHASE2","title":"A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2017-12-07","conditions":"Healthy","enrollment":180},{"nctId":"NCT04354480","phase":"PHASE1","title":"A Study to Evaluate the Single Vaccination of an Adenovirus Serotype 26 Pre-Fusion F (Ad26.preF) Based Respiratory Syncytial Virus (RSV) Vaccine in Japanese Adults Aged 60 Years and Older","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2020-05-15","conditions":"Healthy","enrollment":36},{"nctId":"NCT03795441","phase":"PHASE1","title":"A Shedding Study of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) Vaccine in Adults","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2019-01-07","conditions":"Healthy","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":306030,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Ad26.RSV.preF-based vaccine","genericName":"Ad26.RSV.preF-based vaccine","companyName":"Janssen Vaccines & Prevention B.V.","companyId":"janssen-vaccines-prevention-b-v","modality":"Biologic","firstApprovalDate":"","aiSummary":"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).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}