Abstract
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.
Publication types
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Clinical Trial, Phase III
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adolescent
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Antibodies, Viral / analysis
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Antibodies, Viral / biosynthesis*
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Antibodies, Viral / immunology*
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Condylomata Acuminata / epidemiology
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Condylomata Acuminata / immunology
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Condylomata Acuminata / prevention & control
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Female
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Follow-Up Studies
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Human papillomavirus 11 / immunology
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Human papillomavirus 16 / immunology
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Human papillomavirus 18 / immunology
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Human papillomavirus 6 / immunology
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Humans
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Immunization Schedule
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Papanicolaou Test
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Papillomavirus Infections / immunology*
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Papillomavirus Infections / pathology
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Papillomavirus Infections / prevention & control*
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Papillomavirus Vaccines / immunology*
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Reverse Transcriptase Polymerase Chain Reaction
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Vagina / pathology
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Vaginal Smears
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Vulva / pathology
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Young Adult
Substances
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Antibodies, Viral
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Papillomavirus Vaccines