{"id":"ad26-mos4-hiv","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions (pain, erythema, swelling)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Myalgia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine employs a recombinant adenovirus serotype 26 (Ad26) vector expressing mosaic HIV envelope and Gag proteins designed to match global HIV diversity. This approach aims to elicit both cellular and humoral immune responses that can recognize and control multiple HIV variants, potentially reducing viral load and delaying disease progression in HIV-infected individuals.","oneSentence":"Ad26.Mos4.HIV is a therapeutic HIV vaccine that uses an adenovirus vector to deliver mosaic HIV antigens, stimulating immune responses against diverse HIV strains.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:59:30.558Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HIV-1 infection (therapeutic vaccine in treatment-experienced adults)"}]},"trialDetails":[{"nctId":"NCT04983030","phase":"PHASE1, PHASE2","title":"Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults","status":"ACTIVE_NOT_RECRUITING","sponsor":"Boris Juelg, MD PhD","startDate":"2022-04-01","conditions":"HIV, Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndrome, Acquired","enrollment":36},{"nctId":"NCT06205056","phase":"PHASE1","title":"Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults","status":"RECRUITING","sponsor":"U.S. Army Medical Research and Development Command","startDate":"2024-01-30","conditions":"Human Immunodeficiency Virus","enrollment":78},{"nctId":"NCT02935686","phase":"PHASE1, PHASE2","title":"A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2017-03-31","conditions":"Healthy","enrollment":155},{"nctId":"NCT02788045","phase":"PHASE1, PHASE2","title":"Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2016-07-08","conditions":"Healthy","enrollment":201},{"nctId":"NCT03307915","phase":"PHASE1","title":"A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected Adults on Suppressive Antiretroviral Treatment","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2018-03-05","conditions":"Human Immunodeficiency Virus","enrollment":25},{"nctId":"NCT03964415","phase":"PHASE3","title":"A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2019-10-31","conditions":"Healthy","enrollment":3900},{"nctId":"NCT05769569","phase":"PHASE1","title":"Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission","status":"WITHDRAWN","sponsor":"Henry M. Jackson Foundation for the Advancement of Military Medicine","startDate":"2023-09-01","conditions":"HIV-1-infection","enrollment":""},{"nctId":"NCT03060629","phase":"PHASE2","title":"A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa","status":"TERMINATED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2017-11-03","conditions":"HIV-1","enrollment":2636}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"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.Mos4.HIV","genericName":"Ad26.Mos4.HIV","companyName":"Henry M. Jackson Foundation for the Advancement of Military Medicine","companyId":"henry-m-jackson-foundation-for-the-advancement-of-military-medicine","modality":"Biologic","firstApprovalDate":"","aiSummary":"Ad26.Mos4.HIV is a therapeutic HIV vaccine that uses an adenovirus vector to deliver mosaic HIV antigens, stimulating immune responses against diverse HIV strains. Used for HIV-1 infection (therapeutic vaccine in treatment-experienced adults).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":6,"withResults":4},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}