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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults
Human Vaccines, Volume 7, No. 7, Year 2011
Notification
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Description
Background: Prophylactic vaccination with a quadrivalent HPV (types 6, 11, 16, 18) vaccine (qHPV) has been shown to prevent infection with HPV 6/11/16/18 and associated disease in women and more recently, in men. Here we report on the safety and reactogenicity of the qHPV vaccine in males. A total of 4,065 healthy males aged 16-26 years were enrolled into a randomized, placebo-controlled, double-blind trial. Subjects were randomized 1:1 to receive qHPV vaccine or placebo at day 1, month 2 and month 6. Safety and tolerability were assessed via the collection of reported adverse experiences (AEs). All serious AEs (vaccine- or procedure-related or not) and all deaths occurring during the study were recorded. Safety analyses were conducted in all subjects who received at least one dose of vaccine or placebo. The proportion of subjects who reported at least one injection-site AE was higher in the qHPV vaccine group versus the placebo group (60.1% vs. 53.7%, respectively), however most of these AEs were mild/moderate in intensity. The incidence of at least one systemic AE was comparable between the vaccine and placebo groups (31.7% vs. 31.4%, respectively). There were no vaccine-related serious AEs or deaths. The occurrence of AEs did not increase with each successive injection, and among trial participants who were seropositive for at least one vaccine HPV type at enrollment, the profile of adverse events was similar to that of the entire study cohort. The qHPV vaccine was generally well tolerated in males aged 16-26 years and had a favorable safety profile. © 2011 Landes Bioscience.
Authors & Co-Authors
Duarte Moreira, Edson Duarte
Unknown Affiliation
Palefsky, Joel Michael
Unknown Affiliation
Giuliano, Anna Regina
Unknown Affiliation
Goldstone, Stephen E.
Unknown Affiliation
Aranda, Carlos
Unknown Affiliation
Jessen, Heiko K.
Unknown Affiliation
Hillman, Richard John
Unknown Affiliation
Ferris, Daron G.
Unknown Affiliation
Coutlée, François
Unknown Affiliation
Vardas, Eftyhia
Unknown Affiliation
Brooke Marshall, J.
Unknown Affiliation
Vuocolo, Scott
Unknown Affiliation
Haupt, Richard M.
Unknown Affiliation
Güriş, Dalya
Unknown Affiliation
Garner, Elizabeth I.O.
Unknown Affiliation
Statistics
Citations: 40
Authors: 15
Affiliations: 12
Identifiers
Doi:
10.4161/hv.7.7.15579
e-ISSN:
15548619
Research Areas
Cancer
Disability
Study Design
Cohort Study
Participants Gender
Male
Female