Clinical trial experience with prophylactic HPV 6/11/16/18 VLP vaccine in young women from the Asia-Pacific region

Abstract

Objective: To evaluate results of three phase 3 clinical trials of quadrivalent HPV 6/11/16/18 vaccination of young Asia-Pacific women. Methods: A total of 814 women from the Asia-Pacific region (aged 16 to 26 years) received vaccine or placebo in 1 of 3 protocols. Descriptive analyses focused on the efficacy, safety, and immunogenicity of the vaccine and the natural history of HPV disease. Results: Vaccine efficacy against disease caused by HPV types 6, 11, 16, or 18 was 100% for cervical intraepithelial neoplasia (0 vs 12 cases; 95% confidence interval [CI], 63.1%–100%) and 100% for vulvar and vaginal intraepithelial neoplasia or condylomata accuminata (0 vs 5 cases; 95% CI, − 11.8% to 100%). The vaccination was highly immunogenic. Vaccine recipients experienced a significantly higher injection site adverse event rate ( P = 0.002). Compared with other world regions, lower rates of smoking and baseline positivity to 14 HPV types (including the vaccine types) were observed among Asia-Pacific participants. Conclusion: Prophylactic quadrivalent HPV 6/11/16/18 vaccination of young Asia-Pacific women demonstrated high efficacy, safety, and tolerability. Together with an observed low baseline HPV positivity rate, the Asia-pacific population is potentially an important cohort to benefit from vaccination.