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

• Published in: The Journal of infectious diseases Vol. 199; no. 7; pp. 936 - 944
• Main Authors: 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
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Oxford The University of Chicago Press 01.04.2009; University of Chicago Press; Oxford University Press
• Subjects: Adenocarcinoma; Adenocarcinoma - prevention & control; Adenocarcinoma - virology; Adolescent; Adult; Alphapapillomavirus - classification; Alphapapillomavirus - genetics; Alphapapillomavirus - immunology; Applied microbiology; Biological and medical sciences; Cervical cancer; Cervical intraepithelial neoplasia; Cervical Intraepithelial Neoplasia - prevention & control; Cervical Intraepithelial Neoplasia - virology; Clinical Medicine; Epidemiology; Fees; Female; Fundamental and applied biological sciences. Psychology; Human papillomavirus; Humans; Infections; Infectious diseases; Infectious Medicine; Infektionsmedicin; Klinisk medicin; Lesions; Medical and Health Sciences; Medical sciences; Medicin och hälsovetenskap; Microbiology; Miscellaneous; Papillomavirus Infections - prevention & control; Papillomavirus Infections - virology; Papillomavirus Vaccines; Placebos; Uterine Cervical Neoplasms - prevention & control; Uterine Cervical Neoplasms - virology; Vaccination; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Virology; Viruses; Young Adult; Papillomavirus; Virus; Human; Infection; Human papillomavirus; Microbiology; Virus like particle; Female; Vaccine; Papovaviridae
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/597309

BackgroundWe evaluated the impact of a quadrivalent human papillomavirus (HPV) vaccine on infection and cervical disease related to 10 nonvaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) associated with >20% of cervical cancers. The population evaluated included HPV-naive women and women with preexisting HPV infection and/or HPV-related disease at enrollment MethodsPhase 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 ResultsVaccination 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 ConclusionsThese 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 registrationClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482