An efficacy and immunogenicity study of an investigational 9-valent HPV (6/11/16/18/31/33/45/52/58) (9vHPV) vaccine was conducted in women 16-26 years of age to demonstrate immunological non-inferiority of HPV 6/11/16/18 response and efficacy against HPV 31/33/4/52/58-related disease. The report presents efficacy against vulva-vaginal disease through end-of-study (i.e. up to month 54 visit).
14,204 healthy 16-26 year-old women were enrolled into an international, double-blind efficacy and immunogenicity study of the 9vHPV vaccine. Subjects received 9vHPV vaccine or quadrivalent HPV (qHPV) vaccine as a series of injections at day 1/month 2/month 6. Primary analyses included subjects who were seronegative at day 1 and PCR negative from day 1 through month 7 for the HPV type being analyzed. Gynecological examinations were performed every 6 months, and abnormal areas were biopsied.
12,021 women were eligible for this analysis. Efficacy against vulvovaginal disease caused by HPV 6/11/16/18 was equal to qHPV vaccine. Efficacy against HPV 31/33/45/52/58-related VIN/VaIN (any grade) in the primary analysis was 94.4% (95% CI: 67.7, 99.7). No case of high-grade vulvovaginal disease related to the 5 new types was observed in the 9vHPV vaccine group and 3 cases were observed in the qHPV vaccine group. The number of external genital biopsies related to HPV 31/33/45/52/58 was reduced by 92.3% (95% CI: 72.4-98.7).
The 9vHPV vaccine was highly efficacious in preventing HPV 31/33/45/52/58-related vulvovaginal disease up to month 54 visit. Efficacy against disease caused by HPV 6/11/16/18 was the same as with the qHPV vaccine.