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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
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
Journal of Infectious Diseases, Volume 207, No. 11, Year 2013
Notification
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Description
Background. Cervical 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.Methods. In 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.Results. In 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.Conclusions. The 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. © 2013 The Author.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC3636781/bin/supp_207_11_1753__index.html
https://efashare.b-cdn.net/share/pmc/articles/PMC3636781/bin/supp_jis619_jis619supp_new.doc
Authors & Co-Authors
Sow, Papa Salif
Unknown Affiliation
Watson – Jones, Deborah
Unknown Affiliation
Kiviat, Nancy B.
Unknown Affiliation
Changalucha, John M.
Unknown Affiliation
Diallo-Mbaye, Khardiata
Unknown Affiliation
Brown, Joelle Morgan
Unknown Affiliation
Bousso, Kouro
Unknown Affiliation
Kavishe, Bazil Baltazar
Unknown Affiliation
Andreasen, Aura
Unknown Affiliation
Touré, Macoumba R.
Unknown Affiliation
Kapiga, Saidi Hussein
Unknown Affiliation
Mayaud, Philippe C.
Unknown Affiliation
Hayes, Richard John
Unknown Affiliation
Lebacq, Marie
Unknown Affiliation
Herazeh, Marjan
Unknown Affiliation
Thomas, Florence
Unknown Affiliation
Descamps, Dominique
Unknown Affiliation
Statistics
Citations: 52
Authors: 17
Affiliations: 8
Identifiers
Doi:
10.1093/infdis/jis619
ISSN:
00221899
Research Areas
Cancer
Disability
Infectious Diseases
Participants Gender
Female