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Recombinant Human Papillomavirus Nonavalent Vaccine
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.
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.
At a glance
| Generic name | Recombinant Human Papillomavirus Nonavalent Vaccine |
|---|---|
| Also known as | Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine, Nonavalent HPV Vaccine |
| Sponsor | National Cancer Institute (NCI) |
| Drug class | Recombinant vaccine |
| Target | Human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, 58 |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology |
| Phase | FDA-approved |
Mechanism of action
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.
Approved indications
- 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
- Prevention of genital warts caused by HPV types 6 and 11
Common side effects
- Injection site pain
- Injection site swelling
- Injection site erythema
- Fever
- Headache
- Fatigue
Key clinical trials
- Developing a First-void Urine-based Infection Model to Study HPV-specific Antibody-virion Interaction Before and After HPV Vaccination (PHASE2)
- Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants (PHASE2)
- Testing RG1-VLP Vaccine to Prevent HPV-related Cancers (PHASE1)
- Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial (PHASE4)
- Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia (PHASE2)
- Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions (PHASE2)
- Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients (PHASE2)
- HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV (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 |
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