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Recombinant Human Papillomavirus Bivalent Vaccine
Recombinant Human Papillomavirus Bivalent Vaccine is a Prophylactic vaccine Biologic drug developed by National Cancer Institute (NCI). It is currently FDA-approved for Prevention of cervical cancer caused by HPV-16 and HPV-18, Prevention of cervical intraepithelial neoplasia (CIN) grades 2 and 3. Also known as: Cervarix, GSK-580299, HPV 16/18 L1 VLP/AS04 VAC, HPV-16/18 VLP/AS04 Vaccine.
This vaccine stimulates the immune system to produce antibodies against two types of human papillomavirus (HPV-16 and HPV-18) to prevent infection and cervical cancer development.
This vaccine stimulates the immune system to produce antibodies against two types of human papillomavirus (HPV-16 and HPV-18) to prevent 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 | Recombinant Human Papillomavirus Bivalent Vaccine |
|---|---|
| Also known as | Cervarix, GSK-580299, HPV 16/18 L1 VLP/AS04 VAC, HPV-16/18 VLP/AS04 Vaccine, Human Papillomavirus 16/18 L1 Virus-Like Particle/AS04 Vaccine |
| Sponsor | National Cancer Institute (NCI) |
| Drug class | Prophylactic vaccine |
| Target | Human papillomavirus types 16 and 18 (HPV-16, HPV-18) |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology |
| Phase | FDA-approved |
Mechanism of action
The bivalent HPV vaccine contains recombinant viral-like particles (VLPs) derived from the major capsid protein of HPV types 16 and 18, the two most oncogenic HPV strains. Upon administration, these VLPs trigger both humoral and cellular immune responses, generating neutralizing antibodies and T-cell immunity that prevent initial HPV infection and subsequent malignant transformation of cervical epithelial cells.
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 or soreness
- Injection site swelling or erythema
- Fever
- Myalgia
- Headache
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)
- Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) (PHASE3)
- A Dose Reduction Immunobridging and Safety Study of Two HPV Vaccines in Tanzanian Girls (PHASE3)
- Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ESCUDDO Study (PHASE4)
- Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens With or Without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth (PHASE1)
- 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)
- Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls
- Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study (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:
- Recombinant Human Papillomavirus Bivalent Vaccine CI brief — competitive landscape report
- Recombinant Human Papillomavirus Bivalent Vaccine updates RSS · CI watch RSS
- National Cancer Institute (NCI) portfolio CI
Frequently asked questions about Recombinant Human Papillomavirus Bivalent Vaccine
What is Recombinant Human Papillomavirus Bivalent Vaccine?
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Who makes Recombinant Human Papillomavirus Bivalent Vaccine?
Is Recombinant Human Papillomavirus Bivalent Vaccine also known as anything else?
What drug class is Recombinant Human Papillomavirus Bivalent Vaccine in?
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Related
- Drug class: All Prophylactic vaccine drugs
- Target: All drugs targeting Human papillomavirus types 16 and 18 (HPV-16, HPV-18)
- Manufacturer: National Cancer Institute (NCI) — 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
- Also known as: Cervarix, GSK-580299, HPV 16/18 L1 VLP/AS04 VAC, HPV-16/18 VLP/AS04 Vaccine, Human Papillomavirus 16/18 L1 Virus-Like Particle/AS04 Vaccine
- Compare: Recombinant Human Papillomavirus Bivalent Vaccine vs similar drugs
- Pricing: Recombinant Human Papillomavirus Bivalent Vaccine cost, discount & access