{"id":"mrna-1283","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine delivers self-amplifying mRNA (saRNA) that is translated into HPV16 and HPV18 antigens within host cells, triggering both CD8+ T-cell and antibody responses. This approach aims to treat existing HPV-related cancers and precancerous lesions by mobilizing the patient's own immune system to recognize and eliminate HPV-expressing cells.","oneSentence":"mRNA-1283 is a self-amplifying mRNA vaccine that encodes human papillomavirus (HPV) antigens to stimulate immune responses against HPV-infected cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:56:08.492Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HPV16/18-positive cervical cancer (in combination with Merck's Keytruda)"},{"name":"HPV-related cancers and precancerous lesions"}]},"trialDetails":[{"nctId":"NCT07266558","phase":"PHASE4","title":"A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19)","status":"RECRUITING","sponsor":"ModernaTX, Inc.","startDate":"2025-11-26","conditions":"SARS-CoV-2","enrollment":30000},{"nctId":"NCT07051031","phase":"PHASE4","title":"COVID-19 Reactogenicity","status":"ACTIVE_NOT_RECRUITING","sponsor":"Marcel Curlin","startDate":"2025-10-01","conditions":"COVID-19","enrollment":1000},{"nctId":"NCT07089706","phase":"PHASE4","title":"A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations","status":"RECRUITING","sponsor":"ModernaTX, Inc.","startDate":"2025-07-21","conditions":"COVID-19","enrollment":832},{"nctId":"NCT05137236","phase":"PHASE2","title":"A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters","status":"COMPLETED","sponsor":"ModernaTX, Inc.","startDate":"2021-12-06","conditions":"SARS-CoV-2","enrollment":540},{"nctId":"NCT05815498","phase":"PHASE3","title":"A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19","status":"COMPLETED","sponsor":"ModernaTX, Inc.","startDate":"2023-03-28","conditions":"COVID-19","enrollment":14246},{"nctId":"NCT04813796","phase":"PHASE1","title":"A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19","status":"COMPLETED","sponsor":"ModernaTX, Inc.","startDate":"2021-03-11","conditions":"SARS-CoV-2","enrollment":104}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":15,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"mRNA-1283","genericName":"mRNA-1283","companyName":"ModernaTX, Inc.","companyId":"modernatx-inc","modality":"Biologic","firstApprovalDate":"","aiSummary":"mRNA-1283 is a self-amplifying mRNA vaccine that encodes human papillomavirus (HPV) antigens to stimulate immune responses against HPV-infected cells. Used for HPV16/18-positive cervical cancer (in combination with Merck's Keytruda), HPV-related cancers and precancerous lesions.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}