• J. Infect. Dis. · Jun 2013

    Randomized Controlled Trial Multicenter Study

    Safety and immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine: a randomized trial in 10-25-year-old HIV-Seronegative African girls and young women.

    • Papa Salif Sow, Deborah Watson-Jones, Nancy Kiviat, John Changalucha, Khardiata Diallo Mbaye, Joelle Brown, Kouro Bousso, Bazil Kavishe, Aura Andreasen, Macoumba Toure, Saidi Kapiga, Philippe Mayaud, Richard Hayes, Marie Lebacq, Marjan Herazeh, Florence Thomas, and Dominique Descamps.
    • CHU Fann, Service des Maladies Infectieuses, Dakar (Fann), Senegal.
    • J. Infect. Dis. 2013 Jun 1; 207 (11): 1753-63.

    BackgroundCervical cancer is a major public health problem for women in sub-Saharan Africa. Availability of a human papillomavirus (HPV) vaccine could have an important public health impact.MethodsIn this phase IIIb, double-blind, randomized, placebo-controlled, multicenter trial (NCT00481767), healthy African girls and young women seronegative for human immunodeficiency virus (HIV) were stratified by age (10-14 or 15-25 years) and randomized (2:1) to receive either HPV-16/18 AS04-adjuvanted vaccine (n = 450) or placebo (n = 226) at 0, 1, and 6 months. The primary objective was to evaluate HPV-16/18 antibody responses at month 7. Seropositivity rates and corresponding geometric mean titers (GMTs) were measured by enzyme-linked immunosorbent assay.ResultsIn the according-to-protocol analysis at month 7, 100% of initially seronegative participants in the vaccine group were seropositive for both anti-HPV-16 and anti-HPV-18 antibodies (n = 130 and n = 128 for 10-14-year-olds, respectively; n = 190 and n = 212 for 15-25-year-olds). GMTs for HPV-16 and HPV-18 were higher in 10-14-year-olds (18 423 [95% confidence interval, 16 185-20 970] and 6487 [5590-7529] enzyme-linked immunosorbent assay units (EU)/mL, respectively) than in 15-25-year-olds (10 683 [9567-11 930] and 3743 [3400-4120] EU/mL, respectively). Seropositivity was maintained at month 12. No participant withdrew owing to adverse events. No vaccine-related serious adverse events were reported.ConclusionsThe HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic and had a clinically acceptable safety profile when administered to healthy HIV-seronegative African girls and young women.

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