Immunogenicity of 2 Doses of HPV Vaccine in Younger Adolescents vs 3 Doses in Young Women: A Randomized Clinical Trial

• Autores: Simon R. M. Dobson, Shelly McNeil, Marc Dionne, Meena Dawar, Gina Ogilvie
• Localización: JAMA: the journal of the American Medical Association, ISSN 0098-7484, Vol. 309, Nº. 17, 2013 (Ejemplar dedicado a: Child Health), págs. 1793-1802
• Idioma: inglés
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• Resumen

  • Importance Global use of human papillomavirus (HPV) vaccines to prevent cervical cancer is impeded by cost. A 2-dose schedule for girls may be possible.

    Objective To determine whether mean antibody levels to HPV-16 and HPV-18 among girls receiving 2 doses was noninferior to women receiving 3 doses.

    Design, Setting, and Patients Randomized, phase 3, postlicensure, multicenter, age-stratified, noninferiority immunogenicity study of 830 Canadian females from August 2007 through February 2011. Follow-up blood samples were provided by 675 participants (81%).

    Intervention Girls (9-13 years) were randomized 1:1 to receive 3 doses of quadrivalent HPV vaccine at 0, 2, and 6 months (n = 261) or 2 doses at 0 and 6 months (n = 259). Young women (16-26 years) received 3 doses at 0, 2, and 6 months (n = 310). Antibody levels were measured at 0, 7, 18, 24, and 36 months.