Safety and Immunogenicity of the HPV-16/18 AS04-Adjuvanted Vaccine: A Randomized,Controlled Trial in Adolescent Girls |
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| Authors: | Doris M. Rivera Medina Alejandra Valencia Alet de Velasquez Li-Min Huang Roman Prymula Jose García-Sicilia Lars Rombo Marie Pierre P. David Dominique Descamps Karin Hardt Gary Dubin |
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| Affiliation: | 1. Organización para el Desarrollo y la Investigación Salud en Honduras, Tegucigalpa, Honduras;2. Fundación Santa Fe de Bogotá, Bogotá, Colombia;3. Policlínica Santiago Barraza, Panamá City, Panamá;4. National Taiwan University Hospital, Taipei, Taiwan;5. Faculty of Military Health Sciences, Hradec Kralove, Czech Republic;6. Hospital la Paz, Madrid, Spain;7. Department of Infectious Diseases, Eskilstuna and Karolinska Institute, Stockholm, Sweden;8. Center for Clinical Research, Sörmland County Council, Sweden;9. GlaxoSmithKline Biologicals, Rixensart, Belgium;10. GlaxoSmithKline Biologicals, King of Prussia, Pennsylvania;1. Unit of Infections and Cancer, Cancer Epidemiology Research Program, Catalan Institute of Oncology (ICO), IDIBELL, CIBERESP, L’Hospitalet de Llobregat, Catalonia, Spain;2. Center for Infection Research in Cancer (CIRC) at Moffitt Cancer Center, Tampa, FL, USA;3. Icahn School of Medicine at Mount Sinai, New York, NY, USA;4. Research Unit, Pablo Tobon Uribe Hospital Medellin, Medellín, Colombia;5. Department of Gynaecology and Obstetrics, Odense University Hospital, Odense, Denmark;6. Department of Medicine, University of California San Francisco, San Francisco, CA, USA;7. Merck & Co., Inc., Kenilworth, NJ, USA;1. Public Health Ontario, Toronto, ON, Canada;2. Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada;3. Immunization Policy and Programs, Ontario Ministry of Health and Long-Term Care, Toronto, ON, Canada;1. The National HPV Vaccination Program Register, Victorian Cytology Service, PO Box 310, East Melbourne, VIC 8002, Australia;1. Department of Medical and Surgical Sciences–Pharmacology Unit, University of Bologna, Bologna, Italy;2. Immunology Unit, Policlinico G.B. Rossi University Hospital, Verona, Italy;1. Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), P.O Box 1, 3720 BA, Bilthoven, The Netherlands;2. Department of Pathology, VU University Medical Centre (VUmc), P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;1. Research Unit, Pablo Tobon Uribe Hospital, Medellin, Antioquia, Colombia;2. Vía Libre CRS, Jr. Paraguay 490, Lima 01, Peru;3. University Medical Center Hamburg-Eppendorf, Hamburg, Germany;4. Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil;5. Medical University of Vienna, Comprehensive Cancer Center, Vienna, Austria;6. Department of Obstetrics & Gynecology, Medical University of Graz, Austria;7. Merck & Co., Inc., Kenilworth, NJ, USA |
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| Abstract: | PurposeImmunization of girls against oncogenic human papillomavirus (HPV) types before sexual debut is important for cervical cancer prevention. This phase III blinded, randomized, controlled trial in adolescent girls assessed safety of the HPV-16/18 AS04-adjuvanted vaccine.MethodsGirls (mean age 12 years) in 12 countries received the HPV-16/18 L1 virus-like particle AS04-adjuvanted vaccine (N = 1,035) or hepatitis A virus vaccine as control (N = 1,032) at 0, 1, and 6 months. The primary objective was to compare the occurrence of serious adverse events (SAEs) between groups. HPV-16 and HPV-18 antibody titers were assessed by enzyme-linked immunosorbent assay post-vaccination.ResultsUp to study month 7, 11 girls in the HPV-16/18 vaccine group reported 14 SAEs and 13 girls in the control group reported 15 SAEs. The difference in SAE incidence between groups was .20% (95% CI, ?.78, 1.20). No SAE in the HPV-16/18 vaccine group was considered related to vaccination or led to withdrawal. The incidence of solicited local and general symptoms up to 7 days post-vaccination was moderately higher with the HPV-16/18 vaccine than with control. The incidence of unsolicited symptoms, new onset of chronic diseases, and medically significant conditions was similar between groups. All girls seroconverted for both antigens after three doses of the HPV-16/18 vaccine; geometric mean titers were 19,882.0 and 8,262.0 EU/mL for anti-HPV-16 and -18 antibodies, respectively, in initially seronegative girls.ConclusionsThe HPV-16/18 AS04-adjuvanted vaccine was generally well tolerated and immunogenic when administered to young adolescent females, the primary target of organized vaccination programs. |
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