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.


Sow, PS; Watson-Jones, D; Kiviat, N; Changalucha, J; Mbaye, KD; Brown, J; Bousso, K; Kavishe, B; Andreasen, A; Toure, M; Kapiga, S; Mayaud, P; Hayes, R; Lebacq, M; Herazeh, M; Thomas, F; Descamps, D; (2013) 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. The Journal of infectious diseases, 207 (11). pp. 1753-63. ISSN 0022-1899 DOI: 10.1093/infdis/jis619

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Abstract

: 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.<br/>

Item Type: Article
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
Research Centre: Centre for Global Non-Communicable Diseases (NCDs)
Tropical Epidemiology Group
Vaccine Centre
Centre for Maternal, Reproductive and Child Health (MARCH)
STRIVE
PubMed ID: 23242542
Web of Science ID: 318563200016
URI: http://researchonline.lshtm.ac.uk/id/eprint/613549

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