Huh WK et al. -The nine-valent human papillomavirus (9vHPV; HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58) vaccine has been shown to be effective in women 16-26 years of age.The 9vHPV vaccine was shown to prevent infections, cytological abnormalities, high-grade lesions, and cervical procedures related to HPV 31, 33, 45, 52, and 58, and efficacy was sustained for up to 6 years.

Methods

• A randomised, double-blind, efficacy, immunogenicity, and safety study of the 9vHPV vaccine was conducted at 105 study sites in 18 countries.
• Women 16–26 years of age who were healthy, with no history of abnormal cervical cytology, no previous abnormal cervical biopsy results, and no more than four lifetime sexual partners were randomly assigned to receive 3 intramuscular injections over 6 months of 9vHPV or qHPV (control) vaccine.
• The primary outcomes were incidence of high-grade cervical disease (cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, invasive cervical carcinoma), vulvar disease (vulvar intraepithelial neoplasia grade 2/3, vulvar cancer), and vaginal disease (vaginal intraepithelial neoplasia grade 2/3, vaginal cancer) related to HPV 31, 33, 45, 52, and 58 and non-inferiority (excluding a decrease of 1·5 times) of anti-HPV 6, 11, 16, and 18.

Results

• 14,215 women received 9vHPV (n=7106) or qHPV (n=7109) vaccine.
• The incidence of high-grade cervical, vulvar, and vaginal disease related to HPV 31, 33, 45, 52, and 58 was 0.5 cases per 10,000 person-years in the 9vHPV and 19.0 cases per 10,000 person-years in the qHPV groups, representing 97.4% efficacy.
• HPV 6, 11, 16, and 18 geometric mean titers were non-inferior in the 9vHPV versus qHPV group from month 1 to 3 years after vaccination.
• No signficiant differences in serious adverse events were noted between the study groups.