Journal article
HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine
EA Joura, SK Kjaer, CM Wheeler, K Sigurdsson, OE Iversen, M Hernandez-Avila, G Perez, DR Brown, LA Koutsky, EH Tay, P García, KA Ault, SM Garland, S Leodolter, SE Olsson, GWK Tang, DG Ferris, J Paavonen, M Lehtinen, M Steben Show all
Vaccine | ELSEVIER SCI LTD | Published : 2008
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 ..
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Funding Acknowledgements
Conflict of interest information: NM has received lecture fees, advisory board fees, and consultancy fees from Merck and Sanofi Pasteur MSD. SEC, has received lecture fees froiri Merck. MHA has received lecture fees and grant support from Merck. CEI has received lecture fees from Merck and GIaxoSrnithKIine. CMW has received funding through her institution to conduct HPV vaccine studies for GlaxoSrnithKline. KA has received consultancy and advisory board fees. XB has received lecture fees fron-I Merck and G laxoSrnith Kline, and has received funding through his institution to conduct HPV vaccine Studies GlaxoSmithKiine. JP has received consultancy fees, advisory board fees, and lecture fees from Merck. JD has received consultancy fees, lecture fees, and research grants from Merckand Sanofi Pasteui-MSD.SLhas received lecture fees frorn Merck and Sanofi Pasteur MSD. EJ has received lecture fees from Merck, Sanofi Pasteur MSD and GlixoSmithKline. SKI has received consultancy fees, and has received funding through her institution to conduct HPV vaccine studies for Sanofi Pasteur MSD and Digene. SMG has received advisory board fees and grant support from Commonwealth Serum Laboratories (CSL) and GlaxoSmithl(line, lecture fees from Merck,and fundingthrough her institution to conduct HPV vaccine studies for GSK. DGF has received consultancy fees and funding through his institution to conduct HPV vaccine Studies for GlaxoSmithKline, and lecture fees and consultancy fees from Merck. KS has received consultancy fees from Merck. SM has received lecture fees and advisory board fees from Merck. GP has received lecture fees and constiltancy fees fron-I Merck and Sanofi Pasteur MSD. DRB has received lecture fees, advisory board fees, and intellectual property fees. MS has received lecture fees and grant support from Merck. Additionally, SEO, CMW, MHA, OEL GWKT, XB, JP, JD, EHT, SL, EJ, SKK, GP, SMG, DGF, KS, MS, LK, and DRB have received funding through their institutions to conduct HPV vaccine studies for Merck. FJT, CR, ATIJB, LCL, KEDG, SV, SL, TMH, RH, and EB are employees of Merck and potentially own stock and/or stock options in the cornpiny. Role oftliefundingsource: The studieswere designed by the sponsor (Merck and Co., Inc.) in collaboration with external investigators and an external data and safety monitoring board. The sponsor collated the data, monitored the conduct ofthe study, performed the statistical analysis and coordinated the writing of the manuscript With all authors. The authors were actively involved in the collection, analysis or interpretation ofthe data, the revising of the manuscript for intellectual content, and approved the final manuscript.