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HPV-16/18 L1 VLP AS04
This vaccine stimulates the immune system to produce antibodies against HPV-16 and HPV-18 virus-like particles, preventing infection and cervical cancer development.
This vaccine stimulates the immune system to produce antibodies against HPV-16 and HPV-18 virus-like particles, preventing infection and cervical cancer development. Used for Prevention of cervical cancer caused by HPV-16 and HPV-18, Prevention of cervical intraepithelial neoplasia (CIN) caused by HPV-16 and HPV-18.
At a glance
| Generic name | HPV-16/18 L1 VLP AS04 |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Prophylactic vaccine |
| Target | HPV-16 and HPV-18 L1 capsid protein |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology |
| Phase | Phase 3 |
Mechanism of action
HPV-16/18 L1 VLP AS04 is a prophylactic vaccine containing virus-like particles (VLPs) derived from the major capsid protein (L1) of human papillomavirus types 16 and 18, formulated with the AS04 adjuvant system to enhance immunogenicity. The vaccine triggers both humoral and cellular immune responses that generate neutralizing antibodies against HPV-16 and HPV-18, the two high-risk HPV types responsible for approximately 70% of cervical cancers. By preventing initial infection with these oncogenic HPV types, the vaccine reduces the risk of cervical intraepithelial neoplasia and cervical cancer development.
Approved indications
- Prevention of cervical cancer caused by HPV-16 and HPV-18
- Prevention of cervical intraepithelial neoplasia (CIN) caused by HPV-16 and HPV-18
Common side effects
- Injection site pain
- Injection site redness
- Injection site swelling
- Fatigue
- Myalgia
- Headache
- Fever
Key clinical trials
- Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial (PHASE4)
- Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ESCUDDO Study (PHASE4)
- Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial (PHASE3)
- A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects
- FASTER-Tlalpan Study in Mexico: HPV Vaccination Impact on Cervical Cancer Screening Program (PHASE4)
- Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old (PHASE3)
- Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age (PHASE3)
- A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards. (PHASE4)
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:
- HPV-16/18 L1 VLP AS04 CI brief — competitive landscape report
- HPV-16/18 L1 VLP AS04 updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI