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Gardasil9
Gardasil9 is a recombinant vaccine that stimulates the immune system to produce antibodies against nine types of human papillomavirus (HPV) to prevent infection and associated cancers.
Gardasil9 is a recombinant vaccine that stimulates the immune system to produce antibodies against nine types of human papillomavirus (HPV) to prevent infection and associated cancers. 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 16 and 18, Prevention of genital warts caused by HPV types 6 and 11.
At a glance
| Generic name | Gardasil9 |
|---|---|
| Also known as | GARDASIL®, G9, SILGARD®9, V503, Recombinant 9 valent human papillomavirus vaccine |
| Sponsor | Boston Medical Center |
| Drug class | Recombinant HPV vaccine |
| Target | HPV L1 capsid protein (types 6, 11, 16, 18, 31, 33, 45, 52, 58) |
| Modality | Small molecule |
| Therapeutic area | Oncology / Immunology |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains virus-like particles (VLPs) derived from the L1 major capsid protein of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. When administered, these VLPs trigger a humoral immune response that generates neutralizing antibodies against these HPV types, preventing viral infection of epithelial cells and reducing the risk of HPV-related malignancies and benign lesions.
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 16 and 18
- Prevention of genital warts caused by HPV types 6 and 11
- Prevention of oropharyngeal and other head and neck cancers caused by HPV types 16 and 18
Common side effects
- Injection site pain
- Injection site swelling
- Injection site erythema
- Headache
- Fever
- Nausea
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)
- GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose (PHASE4)
- Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients (PHASE2)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Gardasil9 CI brief — competitive landscape report
- Gardasil9 updates RSS · CI watch RSS
- Boston Medical Center portfolio CI