Human Papillomavirus Types 16 and 18 Vaccine (Recombinant, AS04 Adjuvanted Adsorbed) [Cervarix™]

Abstract▴ Cervarix™ is a prophylactic vaccine comprised of a mixture of virus-like particles derived from the L1 capsid proteins of human papillomavirus (HPV) types 16 and 18 formulated with the AS04 adjuvant system. It is administered by intramuscular injection as a three-dose vaccine regimen at 0, 1 and 6 months. The vaccine is indicated for the prevention of high-grade cervical intraepithelial neoplasia (CIN 2 and CIN 3) and cervical cancer causally related to HPV types 16 and 18.▴ In randomized, double-blind, phase II or III trials in >19 000 women aged 15–25 years, the HPV 16/18 vaccine showed high efficacy in preventing CIN 2+ associated with HPV 16/18. Cross-protection against new incident or 6-month persistent HPV 45 or HPV 31 infection was also evident. Phase II follow-up was for at least 5.5 years, and the phase III interim analysis was at ≈15 months after the first vaccine dose.▴ In a bridging study, in adolescent girls aged 10–14 years, the HPV 16/18 vaccine induced twice the already high antibody titres as it did in young women (aged 15–25 years). The immune response in older women (aged 26–55 years) at 24 months in another study was ≥8-fold higher than antibody levels reported in younger age groups. Anti-HPV 16/18 antibody responses were greater with an AS04-adjuvanted HPV 16/18 vaccine than with an aluminium salt-adjuvanted formulation.▴ The HPV 16/18 vaccine was generally well tolerated and injection-site reactions were the most common vaccine-related adverse events reported.

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