@article{feafca30363540c29c7fe8e3b80e0492,
title = "Comparison of the immunogenicity of the human papillomavirus (HPV)-16/18 vaccine and the HPV-6/11/16/18 vaccine for oncogenic non-vaccine types HPV-31 and HPV-45 in healthy women aged 18-45 years",
abstract = "Protection against oncogenic non-vaccine types (cross-protection) offered by human papillomavirus (HPV) vaccines may provide a significant medical benefit. Available clinical efficacy data suggest the two licensed vaccines [HPV-16/18 vaccine, GlaxoSmithKline Biologicals (GSK), and HPV-6/11/16/18 vaccine, Merck and Co., Inc.,] differ in terms of protection against oncogenic non-vaccine HPV types -31/45. The immune responses induced by the two vaccines against these two non-vaccine HPV types (cross-reactivity) was compared in an observer-blind study up to Month 24 (18 mo postvaccination), in women HPV DNA-negative and seronegative prior to vaccination for the HPV type analyzed [HPV- 010 (NCT00423046)]. Geometric mean antibody titers (GMTs) measured by pseudovirion-based neutralization assay (PBNA) and enzyme-linked immunosorbent assay (ELISA ) were similar between vaccines for HPV-31/45. Seropositivity rates for HPV-31 were also similar between vaccines; however, there was a trend for higher seropositivity with the HPV-16/18 vaccine (13.0-16.7%) vs. the HPV-6/11/16/18 vaccine (0.0-5.0%) for HPV-45 with PBNA, but not ELISA . HPV-31/45 cross-reactive memory B-cell responses were comparable between vaccines. Circulating antigen-specific CD4+ T-cell frequencies were higher for the HPV-16/18 vaccine than the HPV-6/11/16/18 vaccine {HPV-31 [geometric mean ratio (GMR) = 2.0; p = 0.0002] and HPV-45 [GMR = 2.6; p = 0.0092]}, as were the proportion of T-cell responders (HPV-31, p = 0.0009; HPV-45, p = 0.0793). In conclusion, immune response to oncogenic non-vaccine HPV types -31/45 was generally similar for both vaccines with the exception of T-cell response which was higher with the HPV-16/18 vaccine. Considering the differences in cross-protective efficacy between the two vaccines, the results might provide insights into the underlying mechanism(s) of protection.",
keywords = "Cervarix{\textregistered}, Cervical cancer, Cross-protection, Gardasil{\textregistered}, HPV-31, HPV-45, Human papillomavirus, Immunogenicity",
author = "Einstein, {Mark H.} and Mira Baron and Levin, {Myron J.} and Archana Chatterjee and Bradley Fox and Sofia Scholar and Jeffrey Rosen and Nahida Chakhtoura and Marie Lebacq and {Van Der Most}, Robbert and Philippe Moris and Giannini, {Sandra L.} and Anne Schuind and Datta, {Sanjoy K.} and Dominique Descamps",
note = "Funding Information: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf and declare: The submitted work got financial support from GlaxoSmithKline Biologicals. Funding Information: M.E. has advised or participated in educational speaking activities, but does not receive payments from any companies. In specific cases, Montefiore Medical Center has received payment for M.E. time spent for these activities from GSK and Merck. Also, Montefiore has received grant funding for research related costs of clinical trials that M.E. has been the Montefiore PI from GSK and Merck. A.C., N.C., J.R. received support for travel to meetings for the study. A.C., M.J.L., N.C., J.R. received grants for their institutions. A.C. received financial support for board membership. M.J.L. received financial support for consultancy. A.C., B.F., N.C., received payment for lectures including service on speaker bureaus. A.S., D.D., M.L., S.D., P.M., S.G., RvdM are GSK employees. A.S., D.D., S.D., P.M., RvdM have stock options from GSK. S.S., B.F., M.B. declare no conflict of interest. Funding Information: We thank all study participants. This study was sponsored by GlaxoSmithKline Biologicals, Belgium. The team from GlaxoSmithKline Biologicals, US, included Kevin Carrick (Study Manager), J. Ann Jones (Field Monitors), and Joan Adler (Local Medical Monitor). Jesse Lepage (Cincinnati Children{\textquoteright}s Hospital) provided technical expertise in the preparation of samples for the evaluation of B-cell responses. B-cell assays were performed by the Human Cellular Immunity Team at GlaxoSmithKline Biologicals, Belgium (Olivier Jauniaux, Alexandre Smirnoff, Sarah Charpentier, Valerie Mohy, Dinis Fernandez-Ferreira, Samira Hadiy, Michael P. Mestre, Murielle Carton, Pierre Libert, Zineb Soussi and Luc Franssen). Pseudovirion-based neutralization assays and enzyme-linked immunosorbent assays were performed by the Global Vaccine Clinical Readout Development Unit (GVCR DU) team at GlaxoSmithKline Biologicals, Belgium (Rudy Crudenaire, Patrice Pierson, Stephanie Abderhamane, Rita Dereymaeker, France Dufranne, Benjamin Mathieu, Marie Gangarossa, Lieve Lauwers, Jeremy Leurquin, Mailys Pringels, Laurence Torset, Jessica Vanderhaegen for PBNA and Vinciane Lelivre, Michel Malev{\'e}, Mikael Lega for ELISA). Francis Dessy and Sylviane Poncelet (GlaxoSmithKline Biologicals, Belgium) led the PBNA and ELISA analysis, respectively. Jean-Louis Maroye (Modern Solutions for Business SPRI, Belgium) received the randomization list and performed the statistical analyses. Marie Lebacq (GlaxoSmithKline Biologicals, Belgium) supervised the data analyses (without access to the randomization list), and contributed to the statistical QC and writing of the statistical analysis report. The study report was prepared by Kim Nijs (Emtex, C/O GlaxoSmithKline Biologicals, Belgium) and St{\'e}phanie Genevrois (GlaxoSmithKline Biologicals, Belgium). Medical writing assistance was provided by Meridian HealthComms Ltd., (Middlewich, UK) on behalf of GlaxoSmithKline Biologicals. Denis Sohy and Dirk Saerens (GlaxoSmithKline Biologicals, Belgium) provided manuscript coordination on behalf of GlaxoSmithKline. Copyright: Copyright 2012 Elsevier B.V., All rights reserved.",
year = "2011",
month = dec,
doi = "10.4161/hv.7.12.18282",
language = "English (US)",
volume = "7",
pages = "1359--1373",
journal = "Human Vaccines",
issn = "1554-8600",
publisher = "Landes Bioscience",
number = "12",
}