Gonzalo Perez, Luisa L. Villa, Patricia J. Garcia, and Mauricio Hernandez-Avila led clinical sites that participated in the studies analyzed herein. These investigators were compensated for all activities related to execution of the study. Mauricio Hernandez-Avila, Nubia Muñoz, Gonzolo Perez, and Luisa L. Villa have received consultant or other fees from Merck Research Laboratories. Mauricio Hernandez-Avila received grant funding from Merck Research Laboratories. Janine Bryan, Frank J. Taddeo, Shuang Lu, Mark T. Esser, Scott Vuocolo, Carlos Sattler, and Eliav Barr are employees of Merck and potentially own stock and/or stock options in the company.
Infectious Causes of Cancer
Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women†
Article first published online: 13 NOV 2007
Copyright © 2007 Wiley-Liss, Inc.
International Journal of Cancer
Volume 122, Issue 6, pages 1311–1318, 15 March 2008
How to Cite
Perez, G., Lazcano-Ponce, E., Hernandez-Avila, M., García, P. J., Muñoz, N., Villa, L. L., Bryan, J., Taddeo, F. J., Lu, S., Esser, M. T., Vuocolo, S., Sattler, C. and Barr, E. (2008), Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int. J. Cancer, 122: 1311–1318. doi: 10.1002/ijc.23260
- Issue published online: 21 JAN 2008
- Article first published online: 13 NOV 2007
- Manuscript Accepted: 7 SEP 2007
- Manuscript Received: 28 JUN 2007
- Merck Research Laboratories, a division of Merck
- cervical cancer;
The prevalence of HPV infection in Latin America is among the highest in the world. A quadrivalent (types 6/11/16/18) human papillomavirus L1 virus-like-particle vaccine has been shown to be 95–100% effective in preventing HPV 6/11/16/18-related cervical and genital disease in women naïve to vaccine HPV types. A total of 6,004 female subjects aged 9–24 were recruited from Brazil, Mexico, Colombia, Costa Rica, Guatemala and Peru. Subjects were randomized to immunization with intramuscular (deltoid) injections of HPV vaccine or placebo at enrollment (day 1), month 2 and month 6. Among vaccinated subjects in the per-protocol population from Latin America, quadrivalent HPV vaccine was 92.8 and 100% effective in preventing cervical intraepithelial neoplasia and external genital lesions related to vaccine HPV types, respectively. These data support vaccination of adolescents and young adults in the region, which is expected to greatly reduce the burden of cervical and genital cancers, precancers and genital warts. © 2007 Wiley-Liss, Inc.