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Randomized Controlled Trial Multicenter Study
Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18.
- Luisa L Villa, Kevin A Ault, Anna R Giuliano, Ronaldo L R Costa, Carlos A Petta, Rosires P Andrade, Darron R Brown, Alex Ferenczy, Diane M Harper, Laura A Koutsky, Robert J Kurman, Matti Lehtinen, Christian Malm, Sven-Eric Olsson, Brigitte M Ronnett, Finn Egil Skjeldestad, Margareta Steinwall, Mark H Stoler, Cosette M Wheeler, Frank J Taddeo, Jimmy Yu, Lisa Lupinacci, Radha Railkar, Rocio Marchese, Mark T Esser, Janine Bryan, Kathrin U Jansen, Heather L Sings, Gretchen M Tamms, Alfred J Saah, and Eliav Barr.
- Department of Virology, Ludwig Institute for Cancer Research, R. Prof. Antonio Prudente 109, 4th floor, 01509-010 Sao Paulo, SP, Brazil. llvilla@ludwig.org.br
- Vaccine. 2006 Jul 7; 24 (27-28): 5571-83.
AbstractHuman papillomavirus (HPV) infection causes cervical cancer and genital warts. Young women (1106) were randomized to receive one of three formulations of a quadrivalent HPV (Types 6/11/16/18) L1 virus-like particle (VLP) vaccine or one of two placebo formulations. The goal was to assess vaccine safety and immunogenicity in baseline HPV 6/11/16 or 18-naïve and previously infected subjects. All three formulations were highly immunogenic. At Month 2 (postdose 1), among women with vaccine-type antibodies at baseline, vaccine-induced anti-HPV responses were approximately 12- to 26-fold higher than those observed in baseline-naïve women, suggesting an anamnestic response. Following an initial, similar sized decline, anti-HPV responses plateaued and remained stable through end-of-study (3.0 years). No vaccine-related serious adverse experiences were reported.
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