{"id":"recombinant-human-papillomavirus-nonavalent-vaccine","safety":{"commonSideEffects":[{"rate":"50-70","effect":"Injection site pain"},{"rate":"20-30","effect":"Injection site swelling"},{"rate":"20-30","effect":"Injection site erythema"},{"rate":"10-15","effect":"Fever"},{"rate":"10-15","effect":"Headache"},{"rate":"5-10","effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL1201718","moleculeType":"Enzyme"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains virus-like particles (VLPs) derived from the major capsid protein of nine HPV types. Upon administration, these VLPs trigger both humoral and cellular immune responses, generating neutralizing antibodies and T-cell immunity that protect against infection by these HPV strains. This prevents the persistent infections that lead to cervical, anal, oropharyngeal, and other HPV-associated cancers.","oneSentence":"A nonavalent vaccine that stimulates the immune system to produce antibodies against nine types of human papillomavirus (HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58) to prevent HPV-related cancers and diseases.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:04:16.222Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58"},{"name":"Prevention of anal cancer caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58"},{"name":"Prevention of oropharyngeal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58"},{"name":"Prevention of genital warts caused by HPV types 6 and 11"}]},"trialDetails":[{"nctId":"NCT07407569","phase":"PHASE2","title":"Developing a First-void Urine-based Infection Model to Study HPV-specific Antibody-virion Interaction Before and After HPV Vaccination","status":"RECRUITING","sponsor":"Universiteit Antwerpen","startDate":"2026-03-25","conditions":"Human Papilloma Virus Infection Type 16","enrollment":50},{"nctId":"NCT02568566","phase":"PHASE2","title":"Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2016-05-19","conditions":"Human Papillomavirus-Related Carcinoma","enrollment":201},{"nctId":"NCT05985681","phase":"PHASE1","title":"Testing RG1-VLP Vaccine to Prevent HPV-related Cancers","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2025-02-27","conditions":"Human Papillomavirus-Related Carcinoma","enrollment":18},{"nctId":"NCT05237947","phase":"PHASE4","title":"Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2022-03-01","conditions":"Human Papillomavirus-Related Cervical Carcinoma","enrollment":5000},{"nctId":"NCT03519464","phase":"PHASE2","title":"Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2019-02-04","conditions":"Idiopathic CD4 T Cell Lymphocytopenia","enrollment":54},{"nctId":"NCT06658405","phase":"PHASE2","title":"Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions","status":"RECRUITING","sponsor":"Centre Oscar Lambret","startDate":"2025-01-13","conditions":"Cervical Lesion","enrollment":85},{"nctId":"NCT03036930","phase":"PHASE2","title":"Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2017-06-23","conditions":"Human Papillomavirus Infection, Human Papillomavirus-Related Carcinoma","enrollment":51},{"nctId":"NCT03284866","phase":"PHASE3","title":"HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV","status":"COMPLETED","sponsor":"AIDS Malignancy Consortium","startDate":"2019-07-31","conditions":"AIDS-Related Human Papillomavirus Infection, High Grade Cervical Squamous Intraepithelial Neoplasia, HIV Infection","enrollment":536},{"nctId":"NCT06752083","phase":"","title":"Efficacy of Lentinula Edodes-Derived Supplement (AHCC®) in Promoting Negativity of Persistent HPV Infection","status":"COMPLETED","sponsor":"Liaquat University of Medical & Health Sciences","startDate":"2023-01-02","conditions":"HPV Infection","enrollment":289},{"nctId":"NCT04206813","phase":"PHASE4","title":"An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen","status":"ACTIVE_NOT_RECRUITING","sponsor":"Boston Medical Center","startDate":"2020-12-01","conditions":"HPV Infection","enrollment":352},{"nctId":"NCT07314307","phase":"PHASE4","title":"Vaccine Effectiveness of One Dose of the Nonavalent Human Papillomavirus (HPV) Vaccine Among Young-adult Women in Sweden Among Women Participating in a Clinical Trial of Concomitant HPV Vaccination and Screening","status":"ACTIVE_NOT_RECRUITING","sponsor":"Karolinska Institutet","startDate":"2021-05-03","conditions":"Incident HPV16, 18, 31, 33, 45, 52 or 58 Infection","enrollment":150000},{"nctId":"NCT04537156","phase":"PHASE3","title":"Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Xiamen University","startDate":"2020-09-05","conditions":"Cervical Intraepithelial Neoplasia, Cervical Cancer, Condylomata Acuminata","enrollment":9327},{"nctId":"NCT03023631","phase":"PHASE4","title":"Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2017-04-23","conditions":"Allogeneic Hematopoietic Stem Cell Transplant Recipient, Hematopoietic and Lymphoid Cell Neoplasm","enrollment":48},{"nctId":"NCT04265950","phase":"PHASE4","title":"Establishing Optimal Number of Doses for HPV Vaccination in Children and Adolescents Living With HIV, OPTIMO Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"Fred Hutchinson Cancer Center","startDate":"2022-03-10","conditions":"HIV Infection","enrollment":97},{"nctId":"NCT05087849","phase":"PHASE1, PHASE2","title":"Intralesional HPV Vaccine for Condylomata","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2022-04-15","conditions":"Human Papilloma Virus, Warts, Warts, Genital","enrollment":2},{"nctId":"NCT06229353","phase":"","title":"Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department","status":"TERMINATED","sponsor":"University of Alabama at Birmingham","startDate":"2024-08-08","conditions":"Human Papilloma Virus","enrollment":34},{"nctId":"NCT03180034","phase":"PHASE4","title":"Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ESCUDDO Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2017-11-29","conditions":"Human Papillomavirus Infection, Human Papillomavirus-Related Cervical Carcinoma","enrollment":27945},{"nctId":"NCT04982614","phase":"PHASE4","title":"HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini","status":"COMPLETED","sponsor":"Columbia University","startDate":"2022-04-01","conditions":"HPV Infection, Hiv, HPV Vaccine","enrollment":1403},{"nctId":"NCT06197802","phase":"","title":"Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women","status":"ACTIVE_NOT_RECRUITING","sponsor":"Xiamen University","startDate":"2023-12-30","conditions":"Cervical Cancer, Condylomata Acuminata","enrollment":392},{"nctId":"NCT05056402","phase":"PHASE3","title":"An Immuno-bridging Study of a Nonavalent HPV Vaccine (E.Coli) in Healthy Population Aged 9-17 vs Aged 18-26 Years Old","status":"ACTIVE_NOT_RECRUITING","sponsor":"Xiamen University","startDate":"2021-09-19","conditions":"Cervical Cancer, Condylomata Acuminata","enrollment":1382},{"nctId":"NCT05557370","phase":"PHASE4","title":"Immunogenicity of HPV Vaccine in Transplant Recipients.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Medical College of Wisconsin","startDate":"2023-06-01","conditions":"Chronic Kidney Diseases, Kidney Transplant","enrollment":30},{"nctId":"NCT06588257","phase":"PHASE4","title":"Acceptability of the HPV Vaccine and Anal HPV in Transgender Women and Men Who Have Sex With Men: A Pilot Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Fundación Huésped","startDate":"2024-10-09","conditions":"HPV","enrollment":101},{"nctId":"NCT06793410","phase":"PHASE2","title":"Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation","status":"RECRUITING","sponsor":"Vastra Gotaland Region","startDate":"2025-05-12","conditions":"Recipients of Allogeneic Stem Cell Transplantation, HPV (Human Papillomavirus)-Associated, Acute Myeloid Leukaemia","enrollment":100},{"nctId":"NCT05266898","phase":"PHASE4","title":"Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV","status":"RECRUITING","sponsor":"Louisiana State University Health Sciences Center in New Orleans","startDate":"2022-11-30","conditions":"Papillomavirus Vaccines, Human Immunodeficiency Virus, Papillomavirus Infection","enrollment":250},{"nctId":"NCT04235257","phase":"PHASE4","title":"Intradermal, Fractional Dose of HPV Vaccines:","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Washington","startDate":"2020-11-01","conditions":"HPV Infection, HPV Vaccine","enrollment":40},{"nctId":"NCT01824537","phase":"PHASE4","title":"Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study","status":"COMPLETED","sponsor":"McGill University","startDate":"2014-01","conditions":"Human Papillomavirus Infection","enrollment":372},{"nctId":"NCT05496231","phase":"PHASE1, PHASE2","title":"A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2022-08-22","conditions":"Cervical Intraepithelial Neoplasia","enrollment":1080},{"nctId":"NCT00798265","phase":"PHASE1","title":"A Phase I Study of Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) Recombinant Vaccine in HIV-Infected and HIV-Negative Pre-Adolescents, Adolescents, and Young Adults","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","startDate":"2009-06-29","conditions":"Human Immunodeficiency Virus, Human Papillomavirus- 6, 11, 16, 18, Adolescent","enrollment":26},{"nctId":"NCT06681636","phase":"PHASE2","title":"Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure","status":"NOT_YET_RECRUITING","sponsor":"National Institute of Hygiene and Epidemiology, Vietnam","startDate":"2024-12-14","conditions":"HPV Infection, Cervical Cancer, Anogenital Cancer","enrollment":300},{"nctId":"NCT06536855","phase":"PHASE4","title":"Faster Elimination of HPV Infection and Cervical Cancer Using Concomitant HPV Vaccination and HPV Screening: A Demonstration Project in Rwanda","status":"NOT_YET_RECRUITING","sponsor":"Rwanda Biomedical Centre","startDate":"2024-09-01","conditions":"Cervical Cancer","enrollment":100000},{"nctId":"NCT04270773","phase":"PHASE4","title":"Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Hospital Virgen de las Nieves","startDate":"2020-02-12","conditions":"HIV Infections, HPV Infection","enrollment":158},{"nctId":"NCT05625633","phase":"PHASE2, PHASE3","title":"Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts","status":"RECRUITING","sponsor":"Western Institute for Veterans Research","startDate":"2024-03-25","conditions":"Warts","enrollment":120},{"nctId":"NCT03051516","phase":"PHASE4","title":"HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions","status":"TERMINATED","sponsor":"Fred Hutchinson Cancer Center","startDate":"2017-08-01","conditions":"High Grade Anal Canal Intraepithelial Neoplasia, High Grade Vulvar Squamous Intraepithelial Lesion","enrollment":188},{"nctId":"NCT06207175","phase":"PHASE3","title":"A Study to Evaluate the Immunogenicity and Safety of Nonavalent Human Papillomavirus (HPV) Vaccine","status":"UNKNOWN","sponsor":"Beijing Health Guard Biotechnology, Inc","startDate":"2023-11-21","conditions":"Human Papillomavirus Infection","enrollment":1260},{"nctId":"NCT04782895","phase":"PHASE3","title":"Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) Versus Gardasil®9 in Healthy Females 18-26 Years of Age","status":"COMPLETED","sponsor":"Xiamen University","startDate":"2021-03-14","conditions":"Cervical Cancer, Condylomata Acuminata","enrollment":488},{"nctId":"NCT05694728","phase":"PHASE2","title":"A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine","status":"COMPLETED","sponsor":"Beijing Health Guard Biotechnology, Inc","startDate":"2020-05-23","conditions":"Human Papilloma Virus Infection","enrollment":780},{"nctId":"NCT05680454","phase":"PHASE1","title":"A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine","status":"COMPLETED","sponsor":"Beijing Health Guard Biotechnology, Inc","startDate":"2019-09-01","conditions":"Human Papillomavirus Infection","enrollment":160},{"nctId":"NCT05668572","phase":"PHASE3","title":"A Phase III Trial Evaluates the Efficacy, Immunogenicity and Safety Profile of HPV Vaccine","status":"UNKNOWN","sponsor":"Beijing Health Guard Biotechnology, Inc","startDate":"2020-12-05","conditions":"Human Papillomavirus Infection","enrollment":12000},{"nctId":"NCT05662020","phase":"PHASE3","title":"A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China","status":"ACTIVE_NOT_RECRUITING","sponsor":"Beijing Health Guard Biotechnology, Inc","startDate":"2022-03-23","conditions":"Human Papillomavirus Infection","enrollment":2750},{"nctId":"NCT03832049","phase":"PHASE3","title":"HPV Vaccination in Africa- New Delivery Schedules Alias The HANDS HPV Vaccine Trial","status":"UNKNOWN","sponsor":"London School of Hygiene and Tropical Medicine","startDate":"2019-09-14","conditions":"Human Papillomavirus Vaccine","enrollment":1720},{"nctId":"NCT04459221","phase":"PHASE4","title":"Study of the Impact of a School Program Combining - Promotion of HPV Vaccination and HPV Vaccine Offer in Middle School - on Adherence to HPV Vaccination in Middle School Students","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de la Réunion","startDate":"2020-11-01","conditions":"Papilloma Viral Infection","enrollment":355},{"nctId":"NCT01492582","phase":"PHASE2","title":"Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors","status":"COMPLETED","sponsor":"University of Alabama at Birmingham","startDate":"2012-07","conditions":"Cancer Survivor, Prevention of Human Papillomavirus Infection","enrollment":1499},{"nctId":"NCT02968420","phase":"PHASE4","title":"Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine","status":"COMPLETED","sponsor":"University of British Columbia","startDate":"2017-09-11","conditions":"Human Papillomavirus","enrollment":18}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Gardasil 9","Nonavalent HPV VLP Vaccine","Recombinant HPV Nonavalent Vaccine","Recombinant Human Papillomavirus 9-valent Vaccine","Nonavalent HPV Vaccine"],"phase":"marketed","status":"active","brandName":"Recombinant Human Papillomavirus Nonavalent Vaccine","genericName":"Recombinant Human Papillomavirus Nonavalent Vaccine","companyName":"National Cancer Institute (NCI)","companyId":"national-cancer-institute-nci","modality":"Biologic","firstApprovalDate":"","aiSummary":"A nonavalent vaccine that stimulates the immune system to produce antibodies against nine types of human papillomavirus (HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58) to prevent HPV-related cancers and diseases. Used for Prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58, Prevention of anal cancer caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, Prevention of oropharyngeal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":7,"withResults":3},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}