HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine.
(Clinical Trial, Phase III;Journal Article)
The 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.
Joura, EA; Kjaer, SK; Wheeler, CM; Sigurdsson, K; Iversen, O-E; Hernandez-Avila, M; Perez, G; Brown, DR; Koutsky, LA; Tay, EH; García, P; Ault, KA; Garland, SM; Leodolter, S; Olsson, S-E; Tang, GWK; Ferris, DG; Paavonen, J; Lehtinen, M; Steben, M; Bosch, X; Dillner, J; Kurman, RJ; Majewski, S; Muñoz, N; Myers, ER; Villa, LL; Taddeo, FJ; Roberts, C; Tadesse, A; Bryan, J; Lupinacci, LC; Giacoletti, KED; Lu, S; Vuocolo, S; Hesley, TM; Haupt, RM; Barr, E
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