Type: Human Papillomavirus vaccine Types 16 and 18 (Recombinant, AS04 adjuvanted)
Form: Suspension for injection
Manufacturer: GlaxoSmithKline Inc.
Indications and Clinical Use
Indication: Prevention of cervical cancer (squamous cell cancer and adenocarcinoma) in females from 9 to 45 years of age by protecting against HPV types 16 and 18.
Target: Cervical intraepithelial neoplasia (CIN) grade 1, grade 2, grade 3, and cervical adenocarcinoma in situ (AIS).
Contraindications
Hypersensitivity: Should not be administered to individuals with known hypersensitivity to any component of the vaccine.
Warnings and Precautions
General: Prophylactic vaccine, not a treatment for existing HPV infections or related diseases.
Screening: Regular cervical screening is still necessary.
Administration: Care to avoid intravascular administration; caution in individuals with bleeding disorders.
Immune Response: May not elicit protective response in all recipients; special consideration needed for immunosuppressed individuals.
Severe: Rare occurrences of anaphylactic reactions and syncope.
Drug Interactions
Concomitant Vaccines: Can be administered with certain vaccines like BOOSTRIX, MENACTRA, TWINRIX Junior, and ENGERIX-B without clinically relevant interference.
Hormonal Contraceptives: No evidence of impact on vaccine efficacy.
Dosage and Administration
Schedule:
2-dose: For females 9-14 years at 0 and 6 months.
3-dose: For females 15-45 years at 0, 1, and 6 months.
Route: Intramuscular injection in the deltoid region.
Storage and Stability
Store at 2°C to 8°C, do not freeze, protect from light. Stable for up to 3 days at temperatures between 8°C and 25°C or 1 day at temperatures between 25°C and 37°C.
Clinical Trials and Efficacy
Efficacy: Demonstrated high efficacy in preventing CIN2+, CIN3+, and AIS associated with HPV types 16 and 18 in clinical trials.
Immunogenicity: High and sustained antibody levels against HPV-16 and HPV-18.
Long-Term Protection: Demonstrated immune memory response and protection against persistent infection with HPV-16 and HPV-18.
