@article{527eb3c566c24d56b6f6719ea77bbb76,
title = "HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine",
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.",
keywords = "Human Papillomavirus, Humoral immunity, Immune memory",
author = "Joura, {Elmar A.} and Kjaer, {Susanne K.} and Wheeler, {Cosette M.} and Kristj{\'a}n Sigurdsson and Iversen, {Ole Erik} and Mauricio Hernandez-Avila and Gonzalo Perez and Brown, {Darron R.} and Koutsky, {Laura A.} and Tay, {Eng Hseon} and Patricia Garc{\'i}a and Ault, {Kevin A.} and Garland, {Suzanne M.} and Sepp Leodolter and Olsson, {Sven Eric} and Tang, {Grace W.K.} and Ferris, {Daron Gale} and Jorma Paavonen and Matti Lehtinen and Marc Steben and Xavier Bosch and Joakim Dillner and Kurman, {Robert J.} and Slawomir Majewski and Nubia Mu{\~n}oz and Myers, {Evan R.} and Villa, {Luisa L.} and Taddeo, {Frank J.} and Christine Roberts and Amha Tadesse and Janine Bryan and Lupinacci, {Lisa C.} and Giacoletti, {Katherine E.D.} and Shuang Lu and Scott Vuocolo and Hesley, {Teresa M.} and Haupt, {Richard M.} and Eliav Barr",
note = "Funding Information: Conflict of interest information : NM has received lecture fees, advisory board fees, and consultancy fees from Merck and Sanofi Pasteur MSD. SEO has received lecture fees from Merck. MHA has received lecture fees and grant support from Merck. OEI has received lecture fees from Merck and GlaxoSmithKline. CMW has received funding through her institution to conduct HPV vaccine studies for GlaxoSmithKline. KA has received consultancy and advisory board fees. XB has received lecture fees from Merck and GlaxoSmithKline, and has received funding through his institution to conduct HPV vaccine studies GlaxoSmithKline. JP has received consultancy fees, advisory board fees, and lecture fees from Merck. JD has received consultancy fees, lecture fees, and research grants from Merck and Sanofi Pasteur MSD. SL has received lecture fees from Merck and Sanofi Pasteur MSD. EJ has received lecture fees from Merck, Sanofi Pasteur MSD and GlaxoSmithKline. SKK 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 GlaxoSmithKline, lecture fees from Merck, and funding through 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 consultancy fees from 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, OEI, 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, AT, JB, LCL, KEDG, SV, SL, TMH, RH, and EB are employees of Merck and potentially own stock and/or stock options in the company. Role of the funding source : The studies were 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 of the 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 of the data, the revising of the manuscript for intellectual content, and approved the final manuscript. ",
year = "2008",
month = dec,
day = "9",
doi = "10.1016/j.vaccine.2008.09.073",
language = "English (US)",
volume = "26",
pages = "6844--6851",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "52",
}