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A Pooled Analysis of Continued Prophylactic Efficacy of Quadrivalent Human Papillomavirus (Types 6/11/16/18) Vaccine against High-grade Cervical and External Genital Lesions

Authors' Affiliations: ¹ Department of Virus, Hormones and Cancer, Institute of Cancer Epidemiology, Danish Cancer Society/Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; ² National Cancer Detection Clinic, Reykjavik, Iceland; ³ Department of Clinical Medicine, University of Bergen and Department of Obstetrics and Gynecology, Haukeland University Hospital, Bergen, Norway; ⁴ Institute of Public Health, Cuernavaca, Morelos, Mexico; ⁵ Departments of Molecular Genetics and Microbiology and Obstetrics and Gynecology, University of New Mexico, Albuquerque, New Mexico; ⁶ Universidad del Rosario, Bogotá, Colombia; ⁷ Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana; ⁸ Department of Epidemiology, University of Washington, Seattle, Washington; ⁹ KK Women's & Children's Hospital, Singapore, Singapore; ¹⁰ Epidemiology HIV and STD Unit, Universidad Peruana Cayetano Heredia, Lima, Peru; ¹¹ Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, Georgia; ¹² Microbiology and Infectious Diseases Department, Royal Women's Hospital and Department of Obstetrics and Gynecology, University of Melbourne, Melbourne, Victoria, Australia; ¹³ Department of Gynecology and Obstetrics, Medical University of Vienna, Vienna, Austria; ¹⁴ Karolinska Institute at Danderyd Hospital, Stockholm, Sweden; ¹⁵ Department of Obstetrics and Gynecology, University of Hong Kong, Hong Kong Special Administrative Region, China; ¹⁶ Department of Family Medicine and Obstetrics and Gynecology, Medical College of Georgia, Augusta, Georgia; ¹⁷ Department of Obstetrics and Gynecology, University Central Hospital, Helsinki, Finland; ¹⁸ School of Public Health, University of Tampere, Tampere, Finland; ¹⁹ Direction Risques Biologiques, Environnementaux et Occupationnels, Institut National de Santé Publique du Québec, Montreal, Quebec, Canada; ²⁰ Institut Catala d'Oncologia, IDIBELL, Barcelona, Spain; ²¹ Department of Medical Microbiology, Lund University, Lund, Sweden; ²² Department of Dermatology and Venereology, Center of Diagnostics and Treatment of Sexually Transmitted Diseases, Warsaw Medical University, Warsaw, Poland; ²³ National Institute of Cancer, Bogotá, Colombia; ²⁴ Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina; ²⁵ Department of Virology, Ludwig Institute for Cancer Research, Sao Paulo, Brazil; and ²⁶ Merck Research Laboratories, West Point, Pennsylvania

Requests for reprints: Susanne K. Kjaer, Department of Virus, Hormones and Cancer, Institute of Cancer Epidemiology, Danish Cancer Society/Rigshospitalet, Copenhagen, Denmark. Phone: 45-3525-7663; Fax: 45-3525-7663; E-mail: susanne{at}cancer.dk.

Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18–related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or VaIN 2/3). Mean follow-up time was 42 months post dose 1. Vaccine efficacy against HPV 6/11/16/18–related high-grade cervical lesions in the per-protocol and intention-to-treat populations was 98.2% [95% confidence interval (95% CI), 93.3-99.8] and 51.5% (95% CI, 40.6-60.6), respectively. Vaccine efficacy against HPV 6/11/16/18–related high-grade vulvar and vaginal lesions in the per-protocol and intention-to-treat populations was 100.0% (95% CI, 82.6-100.0) and 79.0% (95% CI, 56.4-91.0), respectively. Efficacy in the intention-to-treat population tended to be lower in older women, women with more partners, and women with abnormal Pap test results. The efficacy of quadrivalent HPV vaccine against high-grade cervical and external anogenital neoplasia remains high through 42 months post vaccination.

Key Words: HPV • cervical cancer • vaccine

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