@article{dcd03fd78090462cb22f1e8efc871da8,
title = "Comparative humoral and cellular 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: Follow-up through Month 48 in a Phase III randomized study",
abstract = "We previously reported higher anti-HPV-16 and -18 immune responses induced by HPV-16/18 vaccine compared with HPV-6/11/16/18 vaccine at Month 7 (one month after completion of full vaccination series) in women aged 18-45 y in an observer-blind study NCT00423046; the differences of immune response magnitudes were maintained up to Month 24. Here we report follow-up data through Month 48. At Month 48, in according-to-protocol cohort for immunogenicity (seronegative and DNA-negative for HPV type analyzed at baseline), geometric mean titers of serum neutralizing antibodies were 2.0- to 5.2-fold higher (HPV-16) and 8.6- to 12.8-fold higher (HPV-18) in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. The majority of women in both vaccine groups remained seropositive for HPV-16. The same trend was observed for HPV-18 in HPV-16/18 vaccine group; however, seropositivity rates in HPV-6/11/16/18 vaccine group decreased considerably, particularly in the older age groups. In the total vaccinated cohort (regardless of baseline serological and HPV-DNA status), anti-HPV-16 and -18 neutralizing antibody levels induced by HPV-16/18 vaccine were higher than those induced by HPV-6/11/16/18 vaccine. CD4+ T-cell response for HPV-16 and HPV-18 was higher in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. Memory B-cell responses appeared similar between vaccine groups. Both vaccines were generally well tolerated. Overall, the higher immune response observed with the HPV-16/18 vaccine was maintained up to Month 48. A head-to-head study incorporating clinical endpoints would be required to confirm whether the observed differences in immune response between the vaccines influence the duration of protection they provided.",
keywords = "Cervarix{\textregistered}, Gardasil{\textregistered}, Human papillomavirus, Immunogenicity, Safety",
author = "Einstein, {Mark H.} and Levin, {Myron J.} and Archana Chatterjee and Nahida Chakhtoura and Peter Takacs and Gr{\'e}gory Catteau and Dessy, {Francis J.} and Philippe Moris and Lan Lin and Frank Struyf and Gary Dubin and Mark Blatter and Chambers, {Christopher V.} and Marina Fernandez and Bradley Fox and Fried, {David L.} and Funk, {Sidney A.} and Hansen, {Cheryl A.} and Hedrick, {James A.} and Bethany Hoffman and Klein, {Terry D.} and Jacob Lalezari and Noss, {Michael J.} and Silverblatt, {James H.} and Sperling, {Rhoda S.} and Swenson, {Karen G.} and Troy Thompson and Mark Turner and Warren, {Michael W.} and Robert Yoachim",
note = "Funding Information: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf. Institutions of A.C., M.L. and P.T. received grants from the GlaxoSmithKline group of companies to conduct this study. A.C.{\textquoteright}s previous institution received funding for other clinical trials sponsored by the GlaxoS-mithKline group of companies. M.E. has not received payments from any companies. Montefiore Medical Center received payment for M.E. time spent for the development of educational presentations (GlaxoSmithKline group of companies) and consulting activities (Merck, Bristol-Myers Squibb, Advaxis, Inovio, Photocure, Roche, Aura, and the GlaxoSmithKline group of companies), and for M.E. travel to meetings for the study (Glax-oSmithKline group of companies). A.C. received consulting fees for advisory board membership from the GlaxoSmithKline group of companies and payment for lectures including services on speaker bureaus from Merck and the GlaxoSmithKline group of companies. L.L. is a consultant outsourced from XPE Pharma & Science to the GlaxoSmithKline group of companies. M.L. received consultancy fees from the GlaxoSmithKline group of companies and Merck. M.L. chairs an adjudication committee for another GlaxoSmithKline vaccine and received grants from Merck. M.L. holds the patent and receives royalties from a Merck product. N.C. received payment from the GlaxoSmithKline group of companies for lectures including services on speaker bureaus. F.D., F.S., G.C., G.D. and P.M. are employees of the GlaxoSmithKline group of companies. F.D., F.S. and P.M. own stock in the GlaxoSmithKline group of companies. G.D. receives restricted shares from the GlaxoSmithKline group of companies, and previously received royalties from Wyeth Vaccines. Publisher Copyright: {\textcopyright} 2015 Taylor & Francis.",
year = "2014",
month = dec,
day = "1",
doi = "10.4161/hv.36117",
language = "English (US)",
volume = "10",
pages = "3455--3465",
journal = "Human Vaccines and Immunotherapeutics",
issn = "2164-5515",
publisher = "Landes Bioscience",
number = "12",
}