Efficacy of 9-Valent HPV Vaccine in Young Women

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This was the first phase 3 efficacy clinical trial of a 9-valent HPV vaccine.
This was the first phase 3 efficacy clinical trial of a 9-valent HPV vaccine.

The 9-valent HPV (9vHPV; HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58) vaccine (Gardasil 9; Merck & Co, Inc.) was effective at preventing infection, cytological abnormalities, high-grade lesions, and cervical procedures related to HPV 31, 33, 45, 52, and 58 in a randomized, double-blind efficacy, immunogenicity, and safety study (ClinicalTrials.gov identifier: NCT00543543) published in the Lancet.

Between September 26, 2007, and December 18, 2009, 14,215 healthy women aged 16 to 26 years, from 105 study sites in 18 countries with no prior history of abnormal cervical cytology or biopsy results and no more than 4 lifetime sexual partners, were randomly assigned to receive doses of either the 9vHPV vaccine (n=7106) or the control, quadrivalent HPV (qHPV; HPV 6, 11, 16, and 18) vaccine (n=7109), on day 1 and at 2 and 6 months. Participants were followed for a maximum of 6 years after dose 1 (median, 4.0 years; range, 0-6.0 years) or 5.6 years after dose 3 (median, 3.5 years; range, 0-5.6 years).

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 noninferiority (excluding a decrease of 1.5 times) of anti-HPV 6, 11, 16, and 18 geometric mean titers.

Results showed 97.4% efficacy (95% CI, 85.0%-99.9%) of the 9vHPV vaccine against high-grade cervical, vulvar, and vaginal disease associated with HPV 31, 33, 45, 52, and 58. The 9vHPV vaccine also had a noninferior HPV 6, 11, 16, and 18 antibody response compared with the qHPV vaccine from month 1 to 3 years postvaccination.

"This study shows that many important individual clinical and global public health outcomes are prevented by 9vHPV vaccination" and "could potentially provide broader coverage and prevent 90% of cervical cancer cases worldwide," concluded the investigators.

Disclosure

This study was sponsored and funded by Merck & Co, Inc.

Reference

Huh WK, Joura EA, Giuliano AR, et al. Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16-26 years: a randomised, double-blind trial. Lancet. 2017;390(10108):2143-2159.

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