@article{d52a79dc2f6542cd80abe0e9e9c56cd6,
title = "Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: End-of-study analysis of a Phase III randomized trial",
abstract = "The observer-blind, randomized, age-stratified, head-to-head study (NCT00423046) comparing immunogenicity and safety of HPV-16/18 and HPV-6/11/16/18 vaccines in healthy women aged 18-45 y was completed. Five y after vaccination, in subjects from the Month 60 according-to-protocol cohort (seronegative and DNA negative for HPV type analyzed at baseline), serum neutralizing antibody (nAb) responses induced by HPV-16/18 vaccine remained 7.8-fold (18-26-y stratum), 5.6-fold (27-35-y stratum) and 2.3-fold (36-45-y stratum) higher than those induced by HPV-6/11/16/18 vaccine for HPV-16. For HPV-18, the fold differences were 12.1, 13.0 and 7.8, respectively. At Month 60, all (100%) subjects in HPV-16/18 vaccine group and the majority (95.7%-97.5%) in HPV-6/11/16/18 vaccine group were seropositive for HPV-16. For HPV-18, the majority (98.1%-100%) of subjects in HPV-16/18 vaccine group were seropositive; however, seropositivity rates in HPV-6/11/16/18 vaccine group decreased considerably (61.1%-76.9%) across the 3 age strata. In the total vaccinated cohort (received ≥ 1 dose regardless of baseline HPV serostatus and DNA status), geometric mean titers for anti-HPV-16 and anti-HPV-18 nAb were higher in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. Based on the 5-y data, piece-wise and modified power-law models predicted a longer durability of nAb response for HPV-16/18 vaccine compared to HPV-6/11/16/18 vaccine. Beyond the differences apparent between the vaccines in terms of immunogenicity and modeled persistence of antibody responses, comparative studies including clinical endpoints would be needed to determine whether differences exist in duration of vaccine-induced protection.",
keywords = "Antibodies, Cervarix{\textregistered}, Gardasil{\textregistered}, Human papillomavirus, Immunogenicity, Models, Neutralizing, Safety, Statistical",
author = "{HPV-010 Study Group} and Einstein, {Mark H.} and Peter Takacs and Archana Chatterjee and Sperling, {Rhoda S.} and Nahida Chakhtoura and Blatter, {Mark M.} and Jacob Lalezari and David, {Marie Pierre} and Lan Lin and Frank Struyf and Gary Dubin",
note = "Funding Information: Institutions of A.C., M.B., R.S., N.C. and P.T. received grant from the GlaxoSmithKline group of companies to conduct this study. A.C.{\textquoteright}s previous institution received funding for other clinical trials sponsored by Merck. M.B. also received research grants for conducting other clinical trials sponsored by Sanofi, Novartis and the GlaxoSmithKline group of companies. M.E. did not receive an honorarium from any companies. Montefiore Medical Center has received payment from Merck, Roche, Bristol-Myers Squibb, Hologic, Advaxis, Aura Biosciences, Inovio, Photocure, PDS Biotechnologies and the GlaxoSmithKline group of companies for M.E. time spent on educational speaking activities. If travel is required for meetings with any industry, the company paid for M.E.{\textquoteright}s travel expenses. Also, Montefiore Medical Center has received grant funding from Merck, Roche, Advaxis, Photo-cure, Inovio, Endocyte, Fujiboro, Eli Lilly, PDS Biotechnologies, Becton-Dickinson, Cepheid, Hologic and the GlaxoSmithKline group of companies for research related costs of clinical trials where M.E. has been the overall Principal Investigator or Monte-fiore Principal Investigator. M.B. has received honoraria and served on advisory boards for Sanofi, Novartis and the GlaxoS-mithKline group of companies. A.C. received fees from Merck and the GlaxoSmithKline group of companies for participating in advisory boards and for lectures including services on speaker bureaus. L.L. is a consultant outsourced from XPE Pharma & Science to the GlaxoSmithKline group of companies. J.L. has no conflict of interest to declare. G.D., M-P.D. and F.S. are employees of the GlaxoSmithKline group of companies and receive stock options/restricted shares from the GlaxoSmithKline group of companies. G.D. holds patents in the Human Papillomavirus and Herpes Simplex virus vaccine fields. Publisher Copyright: {\textcopyright} 2015 Taylor & Francis.",
year = "2014",
month = dec,
day = "1",
doi = "10.4161/hv.36121",
language = "English (US)",
volume = "10",
pages = "3435--3445",
journal = "Human Vaccines and Immunotherapeutics",
issn = "2164-5515",
publisher = "Landes Bioscience",
number = "12",
}
