Cervarix™ is a bivalent virus-like particle (VLP) vaccine adjuvanted with monophosphoryl lipid A and alum, designed to provide protection against infection with genital tract human papillomaviruses (HPVs) types 16 and 18, which account for over 70% of cervical cancers. A phase II study and an interim analysis of a phase III study showed that Cervarix™ is safe and well tolerated in young women aged 15-25 years. In both studies, the vaccine was highly immunogenic (100% seroconversion rates) and after 4.5 years of follow-up, vaccine-induced antibody titers were over 14-17-fold higher than those noted for natural infection. The efficacy of Cervarix™ for preventing persistent HPV-16 and/or -18 infection at the cervix was 80-94%. Cervarix™ also provided significant cross-protection against infection with genetically closely related HPV types 31 and 45. Interim analysis of the phase III study indicated that the efficacy of Cervarix™ in preventing HPV-16/18-related cervical intraepithelial neoplasia (CIN) grade 2/3 may be as high as 100%.
ASJC Scopus subject areas
- Pharmacology (medical)