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 generally HPV-naive women aged 16-26 years

Darron R. Brown, Susanne K. Kjaer, Kristján Sigurdsson, Ole Erik Iversen, Hernandez Avila Mauricio, Cosette M. Wheeler, Gonzalo Perez, Laura A. Koutsky, Eng Hseon Tay, Patricía Garcia, 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, Heather L. Sings, Margaret James, Teresa M. Hesley, Eliav Barra

Research output: Contribution to journalArticle

Abstract

Background. Human papillomavirus (HPV)-6/11/16/18 vaccine reduces the risk of HPV-6/11/16/18-related cervical intraepithelial neoplasia (CIN) 1-3 or adenocarcinoma in situ (AIS). Here, its impact on CIN1-3/AIS associated with nonvaccine oncogenic HPV types was evaluated. Methods. We enrolled 17,622 women aged 16-26 years. All underwent cervicovaginal sampling and Pap testing at regular intervals for up to 4 years. HPV genotying was performed for biopsy samples, and histological diagnoses were determined by a pathology panel. Analyses were conducted among subjects who were negative for 14 HPV types on day 1. Prespecified analyses included infection of-6 months' duration and CIN1-3/AIS due to the 2 and 5 most common HPV types in cervical cancer after HPV types 16 and 18, as well as all tested nonvaccine types. Results. Vaccination reduced the incidence of HPV-31/45 infection by 40.3% (95% confidence interval [CI], 13.9% to 59.0%) and of CIN1-3/AIS by 43.6% (95% CI, 12.9% to 64.1%), respectively. The reduction in HPV-31/ 33/45/52/58 infection and CIN1-3/AIS was 25.0% (95% CI, 5.0% to 40.9%) and 29.2% (95% CI, 8.3% to 45.5%), respectively. Efficacy for CIN2-3/AIS associated with the 10 nonvaccine HPV types was 32.5% (95% CI, 6.0% to 51.9%). Reductions were most notable for HPV-31. Conclusions. HPV-6/11/16/18 vaccine reduced the risk of CIN2-3/AIS associated with nonvaccine types responsible for 20% of cervical cancers. The clinical benefit of cross-protection is not expected to be fully additive to the efficacy already observed against HPV-6/11/16/18-related disease, because women may have >1 CIN lesion, each associated with a different HPV type. Trial registration. ClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482.

Original languageEnglish (US)
Pages (from-to)926-935
Number of pages10
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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    Brown, D. R., Kjaer, S. K., Sigurdsson, K., Iversen, O. E., Mauricio, H. A., Wheeler, C. M., Perez, G., Koutsky, L. A., Tay, E. H., Garcia, 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 generally HPV-naive women aged 16-26 years. Journal of Infectious Diseases, 199(7), 926-935. https://doi.org/10.1086/597307