The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years.
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Wheeler Cosette M, Kjaer Susanne K, Sigurdsson Kristján, Iversen Ole-Erik, Hernandez-Avila Mauricio, Perez Gonzalo, Brown Darron R, Koutsky Laura A, Tay Eng Hseon, García Patricia, Ault Kevin A, Garland Suzanne M, Leodolter Sepp, Olsson Sven-Eric, Tang Grace W K, Ferris Daron G, Paavonen Jorma, Steben Marc, Bosch F Xavier, Dillner Joakim, Joura Elmar A, Kurman Robert J, Majewski Slawomir, Muñoz Nubia, Myers Evan R, Villa Luisa L, Taddeo Frank J, Roberts Christine, Tadesse Amha, Bryan Janine, Lupinacci Lisa C, Giacoletti Katherine E D, James Margaret, Vuocolo Scott, Hesley Teresa M, Barr Eliav
Аннотация
METHODS: Phase 3 efficacy studies enrolled 17,622 women aged 16-26 years. Subjects underwent cervicovaginal sampling and Pap testing on day 1 and then at 6-12-month intervals for up to 4 years. HPV typing was performed on samples from enrollment and follow-up visits, including samples obtained for diagnosis or treatment of HPV-related disease. All subjects who received 1 dose and returned for follow-up were included.
RESULTS: Vaccination reduced the rate of HPV-31/33/45/52/58 infection by 17.7% (95% confidence interval [CI], 5.1% to 28.7%) and of cervical intraepithelial neoplasia (CIN) 1-3 or adenocarcinoma in situ (AIS) by 18.8% (95% CI, 7.4% to 28.9%). Vaccination also reduced the rate of HPV-31/58/59-related CIN1-3/AIS by 26.0% (95% CI, 6.7% to 41.4%), 28.1% (95% CI, 5.3% to 45.6%), and 37.6% (95% CI, 6.0% to 59.1%), respectively. Although a modest reduction in HPV-31/33/45/52/58-related CIN2 or worse was observed, the estimated reduction was not statistically significant.
CONCLUSIONS: These cross-protection results complement the vaccine's prophylactic efficacy against disease associated with HPV-6, -11, -16, and -18. Long-term monitoring of vaccinated populations are needed to fully ascertain the population-based impact and public health significance of these findings.
TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT00092521 , NCT00092534 , and NCT00092482.