A recombinant, non-infectious, virus-like particle (VLP) vaccine containing purified L1 capsid proteins of Human Papillomavirus (HPV) types 16 and 18. It is adjuvanted with AS04 (aluminum hydroxide and 3-O-desacyl-4'-monophosphoryl lipid A) to enhance and prolong the immune response. It is indicated for the prevention of cervical cancer and other HPV 16/18-related precancerous lesions and diseases.
Adult Dosage: Females aged 18-25 years: 0.5 ml intramuscularly, preferably in the deltoid region. Three-dose schedule: Month 0, 1, and 6.
Instructions: For intramuscular use only. Shake the vial/pre-filled syringe well before use. Inspect for particulate matter and discoloration. Administer in the deltoid muscle. Do not administer intravenously, intradermally, or subcutaneously. Do not mix with any other vaccine or product in the same syringe.
The vaccine contains recombinant HPV L1 major capsid proteins that self-assemble into non-infectious, non-oncogenic Virus-Like Particles (VLPs) that are morphologically and immunologically identical to the natural virus. Upon intramuscular administration, these VLPs are taken up by antigen-presenting cells (APCs), leading to a robust humoral (B-cell) immune response. The AS04 adjuvant system (Aluminum salt + MPL) enhances the immune response by activating the innate immune system via Toll-like receptor 4 (TLR4), leading to a stronger and more persistent adaptive immune response compared to aluminum salt alone.