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HPV-16/18 L1/AS04
HPV-16/18 L1/AS04 is a Recombinant protein vaccine with adjuvant Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Prevention of cervical cancer caused by HPV-16 and HPV-18, Prevention of cervical intraepithelial neoplasia (CIN) grades 2 and 3.
This vaccine stimulates the immune system to produce antibodies and cellular immunity against HPV-16 and HPV-18 L1 capsid proteins, preventing infection and cervical cancer development.
This vaccine stimulates the immune system to produce antibodies and cellular immunity against HPV-16 and HPV-18 L1 capsid proteins, 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) grades 2 and 3.
At a glance
| Generic name | HPV-16/18 L1/AS04 |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Recombinant protein vaccine with adjuvant |
| Target | HPV-16 L1 and HPV-18 L1 capsid proteins |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology |
| Phase | Phase 3 |
Mechanism of action
HPV-16/18 L1/AS04 is a recombinant protein vaccine containing virus-like particles (VLPs) of HPV types 16 and 18 combined with the AS04 adjuvant system (aluminum hydroxide and MPL). The vaccine triggers both humoral and cell-mediated immune responses against the major capsid protein (L1), enabling the body to neutralize and clear HPV infection before malignant transformation occurs.
Approved indications
- Prevention of cervical cancer caused by HPV-16 and HPV-18
- Prevention of cervical intraepithelial neoplasia (CIN) grades 2 and 3
Common side effects
- Injection site pain/soreness
- Injection site erythema
- 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
- Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (GSK580299) in Healthy Female Subjects 10-25 Years of Age. (PHASE3)
- FASTER-Tlalpan Study in Mexico: HPV Vaccination Impact on Cervical Cancer Screening Program (PHASE4)
- Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls (PHASE3)
- Effectiveness of Single Dose or Two Doses of Bivalent HPV Vaccine in Thailand (NA)
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/AS04 CI brief — competitive landscape report
- HPV-16/18 L1/AS04 updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about HPV-16/18 L1/AS04
What is HPV-16/18 L1/AS04?
How does HPV-16/18 L1/AS04 work?
What is HPV-16/18 L1/AS04 used for?
Who makes HPV-16/18 L1/AS04?
What drug class is HPV-16/18 L1/AS04 in?
What development phase is HPV-16/18 L1/AS04 in?
What are the side effects of HPV-16/18 L1/AS04?
What does HPV-16/18 L1/AS04 target?
Related
- Drug class: All Recombinant protein vaccine with adjuvant drugs
- Target: All drugs targeting HPV-16 L1 and HPV-18 L1 capsid proteins
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Oncology / Immunology
- Indication: Drugs for Prevention of cervical cancer caused by HPV-16 and HPV-18
- Indication: Drugs for Prevention of cervical intraepithelial neoplasia (CIN) grades 2 and 3