-
Randomized Controlled Trial
HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine.
- Elmar A Joura, Susanne K Kjaer, Cosette M Wheeler, Kristján Sigurdsson, Ole-Erik Iversen, Mauricio Hernandez-Avila, 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, Matti Lehtinen, Marc Steben, Xavier Bosch, Joakim Dillner, 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, Shuang Lu, Scott Vuocolo, Teresa M Hesley, Richard M Haupt, and Eliav Barr.
- Department of Gynecology and Obstetrics, Medical University of Vienna, Vienna, Austria. elmar.joura@meduniwien.ac.at
- Vaccine. 2008 Dec 9; 26 (52): 6844-51.
AbstractThe efficacy of the quadrivalent Human Papillomavirus (HPV) vaccine is thought to be mediated by humoral immunity. We evaluated the correlation between quadrivalent HPV vaccine-induced serum anti-HPV responses and efficacy. 17,622 women were vaccinated at day 1, and months 2 and 6. At day 1 and at 6-12 months intervals for up to 48 months, subjects underwent Papanicolaou and genital HPV testing. No immune correlate of protection could be found due to low number of cases. Although 40% of vaccine subjects were anti-HPV 18 seronegative at end-of-study, efficacy against HPV 18-related disease remained high (98.4%; 95% CI: 90.5-100.0) despite high attack rates in the placebo group. These results suggest vaccine-induced protection via immune memory, or lower than detectable HPV 18 antibody titers.
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