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HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine

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Joura, Elmar A.
Kjaer, Susanne K.
Wheeler, Cosette M.
Sigurdsson, Kristján
Iversen, Ole-Erik
Hernandez-Avila, Mauricio
Perez, Gonzalo
Brown, Darron R.
Koutsky, Laura A.
Tay, Eng Hseon



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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. © 2008 Elsevier Ltd. All rights reserved.
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Placebo , Silgard , Unclassified drug , Virus antibody , Wart virus vaccine , Adolescent , Adult , Antibody production , Antibody response , Article , Cancer immunization , Cancer prevention , Clinical trial , Controlled clinical trial , Controlled study , Double blind procedure , Drug efficacy , Female , Human , Infection prevention , Major clinical study , Phase 3 clinical trial , Priority journal , Randomized controlled trial , Uterine cervix carcinoma in situ , Wart virus , Adolescent , Antibodies , Condylomata acuminata , Female , Follow-up studies , Human papillomavirus 11 , Human papillomavirus 16 , Human papillomavirus 18 , Human papillomavirus 6 , Humans , Immunization schedule , Papillomavirus infections , Papillomavirus vaccines , Reverse transcriptase polymerase chain reaction , Vagina , Vaginal smears , Vulva , Young adult , Human papillomavirus , Humoral immunity , Immune memory