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Title: A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women
Authors: E. A. Joura
A. R. Giuliano
O. E. Iversen
C. Bouchard
C. Mao
J. Mehlsen
E. D. Moreira
Y. Ngan
L. K. Petersen
E. Lazcano-Ponce
P. Pitisuttithum
J. A. Restrepo
G. Stuart
L. Woelber
Y. C. Yang
J. Cuzick
S. M. Garland
W. Huh
S. K. Kjaer
O. M. Bautista
I. S.F. Chan
J. Chen
R. Gesser
E. Moeller
M. Ritter
S. Vuocolo
A. Luxembourg
Medizinische Universitat Wien
Moffitt Cancer Center
Helse Bergen Haukeland University Hospital
Universite Laval
The University of British Columbia
University of Washington, Seattle
Kobenhavns Universitet
Fundacao Oswaldo Cruz
The University of Hong Kong
Arhus Universitetshospital
Instituto Nacional de Salud Publica
Mahidol University
Investigación Clínica
Universitatsklinikum Hamburg-Eppendorf und Medizinische Fakultat
Mackay Memorial Hospital Taiwan
Barts and The London School of Medicine and Dentistry
University of Melbourne
University of Alabama
Merck & Co., Inc.
Keywords: Medicine
Issue Date: 19-Feb-2014
Citation: New England Journal of Medicine. Vol.372, No.8 (2014), 711-723
Abstract: © 2015 Massachusetts Medical Society. BACKGROUND: The investigational 9-valent viruslike particle vaccine against human papillomavirus (HPV) includes the HPV types in the quadrivalent HPV (qHPV) vaccine (6, 11, 16, and 18) and five additional oncogenic types (31, 33, 45, 52, and 58). Here we present the results of a study of the efficacy and immunogenicity of the 9vHPV vaccine in women 16 to 26 years of age. METHODS: We performed a randomized, international, double-blind, phase 2b-3 study of the 9vHPV vaccine in 14,215 women. Participants received the 9vHPV vaccine or the qHPV vaccine in a series of three intramuscular injections on day 1 and at months 2 and 6. Serum was collected for analysis of antibody responses. Swabs of labial, vulvar, perineal, perianal, endocervical, and ectocervical tissue were obtained and used for HPV DNA testing, and liquid-based cytologic testing (Papanicolaou testing) was performed regularly. Tissue obtained by means of biopsy or as part of definitive therapy (including a loop electrosurgical excision procedure and conization) was tested for HPV. RESULTS: The rate of high-grade cervical, vulvar, or vaginal disease irrespective of HPV type (i.e., disease caused by HPV types included in the 9vHPV vaccine and those not included) in the modified intention-to-treat population (which included participants with and those without prevalent infection or disease) was 14.0 per 1000 person-years in both vaccine groups. The rate of high-grade cervical, vulvar, or vaginal disease related to HPV-31, 33, 45, 52, and 58 in a prespecified per-protocol efficacy population (susceptible population) was 0.1 per 1000 person-years in the 9vHPV group and 1.6 per 1000 person-years in the qHPV group (efficacy of the 9vHPV vaccine, 96.7%; 95% confidence interval, 80.9 to 99.8). Antibody responses to HPV-6, 11, 16, and 18 were noninferior to those generated by the qHPV vaccine. Adverse events related to injection site were more common in the 9vHPV group than in the qHPV group. CONCLUSIONS: The 9vHPV vaccine prevented infection and disease related to HPV-31, 33, 45, 52, and 58 in a susceptible population and generated an antibody response to HPV-6, 11, 16, and 18 that was noninferior to that generated by the qHPV vaccine. The 9vHPV vaccine did not prevent infection and disease related to HPV types beyond the nine types covered by the vaccine. (Funded by Merck; number, NCT00543543).
ISSN: 15334406
Appears in Collections:Scopus 2011-2015

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