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Title: Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial
Authors: Nubia Muñoz
Ricardo Manalastas
Punee Pitisuttithum
Damrong Tresukosol
Joseph Monsonego
Kevin Ault
Christine Clavel
Joaquin Luna
Evan Myers
Sara Hood
Oliver Bautista
Janine Bryan
Frank J. Taddeo
Mark T. Esser
Scott Vuocolo
Richard M. Haupt
Eliav Barr
Alfred Saah
National Cancer Institute
Philippine General Hospital
Mahidol University
King Chulalongkorn Memorial Hospital, Faculty of Medicine Chulalongkorn University
Federation Mutualiste Parisienne
Emory University School of Medicine
CHU de Reims
Duke University School of Medicine
Merck & Co., Inc.
Keywords: Medicine
Issue Date: 5-Jun-2009
Citation: The Lancet. Vol.373, No.9679 (2009), 1949-1957
Abstract: Background: Although the peak incidence of human papillomavirus (HPV) infection occurs in most populations within 5-10 years of first sexual experience, all women remain at risk for acquisition of HPV infections. We tested the safety, immunogenicity, and efficacy of the quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like-particle vaccine in women aged 24-45 years. Methods: Women aged 24-45 years with no history of genital warts or cervical disease were enrolled from community health centres, academic health centres, and primary health-care providers into an ongoing multicentre, parallel, randomised, placebo-controlled, double-blind study. Participants were allocated by computer-generated schedule to receive quadrivalent HPV vaccine (n=1911) or placebo (n=1908) at day 1, and months 2 and 6. All study site investigators and personnel, study participants, monitors, and central laboratory personnel were blinded to treatment allocation. Coprimary efficacy endpoints were 6 months' or more duration of infection and cervical and external genital disease due to HPV 6, 11, 16, 18; and due to HPV 16 and 18 alone. Primary efficacy analyses were done in a per-protocol population, but intention-to-treat analyses were also undertaken. This study is registered with, number NCT00090220. Findings: 1910 women received at least one dose of vaccine and 1907 at least one dose of placebo. In the per-protocol population, efficacy against the first coprimary endpoint (disease or infection related to HPV 6, 11, 16, and 18) was 90·5% (95% CI 73·7-97·5, four of 1615 cases in the vaccine group vs 41/1607 in the placebo group) and 83·1% (50·6-95·8, four of 1601 cases vs 23/1579 cases) against the second coprimary endpoint (disease or infection related to HPV 16 and 18 alone). In the intention-to-treat population, efficacy against the first coprimary endpoint was 30·9% (95% CI 11·1-46·5, 108/1886 cases vs 154/1883 cases) and against the second coprimary endpoint was 22·6% (-2·9 to 41·9, 90/1886 cases vs 115/1883 cases), since infection and disease were present at baseline. We recorded no vaccine-related serious adverse events. Interpretation: The quadrivalent HPV vaccine is efficacious in women aged 24-45 years not infected with the relevant HPV types at enrolment. Funding: Merck (USA). © 2009 Elsevier Ltd. All rights reserved.
ISSN: 01406736
Appears in Collections:Scopus 2006-2010

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