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

Cosette M. Wheeler, Susanne K. Kjaer, Kristján Sigurdsson, Ole Erik Iversen, Hernandez Avila Mauricio, Gonzalo Perez, Darron R. Brown, Laura A. Koutsky, Eng Hseon Tay, Patricia García, Kevin A. Ault, Suzanne M. Garland, Sepp Leodolter, Sven Eric Olsson, Grace W.K. Tang, Daron G. Ferris, Jorma Paavonen, Marc Steben, F. Xavier Bosch, Joakim DillnerElmar A. Joura, Robert J. Kurman, Slawomir Majewski, Nubia Muñoz, Evan R. Myers, Luisa L. Villa, Frank J. Taddeo, Christine Roberts, Amha Tadesse, Janine Bryan, Lisa C. Lupinacci, Katherine E.D. Giacoletti, Margaret James, Scott Vuocolo, Teresa M. Hesley, Eliav Barra

Research output: Contribution to journalArticle

207 Scopus citations

Abstract

Background. We 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. 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.

Original languageEnglish (US)
Pages (from-to)936-944
Number of pages9
JournalJournal of Infectious Diseases
Volume199
Issue number7
DOIs
StatePublished - Apr 1 2009

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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    Wheeler, C. M., Kjaer, S. K., Sigurdsson, K., Iversen, O. E., Mauricio, H. A., Perez, G., Brown, D. R., Koutsky, L. A., Tay, E. H., García, P., Ault, K. A., Garland, S. M., Leodolter, S., Olsson, S. E., Tang, G. W. K., Ferris, D. G., Paavonen, J., Steben, M., Bosch, F. X., ... Barra, E. (2009). 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. Journal of Infectious Diseases, 199(7), 936-944. https://doi.org/10.1086/597309