Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/9130
Title: Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.
Authors: Moreira Júnior, Edson Duarte
Palefsky, Joel M
Giuliano, Anna R
Goldstone, Stephen
Aranda, Carlos
Jessen, Heiko
Hillman, Richard J
Ferris, Daron G
Coutlee, Francois
Vardas, Eftyhia
Marshall, J. Brooke
Vuocolo, Scott
Haupt, Richard M
Guris, Dalya
Garner, Elizabeth I. O
Affilliation: Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
University of California San Francisco. Department of Medicine. San Francisco, CA, USA
Risk Assessment, Detection. Tampa, FL, USA / Intervention Program. H. Lee Moffitt Cancer Center and Research Institute. Tampa, FL, USA
Mount Sinai School of Medicine. New York, NY, USA
University Medical Center. National Public Health Institute. Morelos, Mexico
J2: Private Clinic for Infectious Diseases. Berlin, Germany
University of Sydney. STI Research Centre. Sydney, Australia
Medical College of Georgia. Augusta, GA, USA
Université de Montréal. Centre de recherche du CHUM. Montréal, QC, Canada
University of Stellenbosch. South Africa. Division of Medical Virology. Johannesburg, South Africa / Lancet Laboratories. Johannesburg, South Africa
Merck & Co., Inc. North Wales, PA, USA
Merck & Co., Inc. North Wales, PA, USA
Merck & Co., Inc. North Wales, PA, USA
Merck & Co., Inc. North Wales, PA, USA
Merck & Co., Inc. North Wales, PA, USA
Abstract: 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.
Keywords: Human papillomavirus (HPV)
Vaccine
Safety
Male
Adult
Adolescent
DeCS: Vacinas contra Papillomavirus
Vacinação/efeitos adversos
Adolescente
Adulto
Método Duplo-Cego
Feminino
Papillomavirus Humano 11/imunologia
Papillomavirus Humano 16/imunologia
Humanos
Masculino
Infecções por Papillomavirus/imunologia
Infecções por Papillomavirus/prevenção & controle
Vacinas contra Papillomavirus/administração & dosagem
Vacinas contra Papillomavirus/efeitos adversos
Segurança
Adulto Jovem
Issue Date: 2011
Publisher: Taylor & Francis
Citation: MOREIRA JUNIOR, E. D. et al. 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, v. 7, n. 7, p. 768-775, 2011.
DOI: dx.doi.org/10.4161/hv.7.7.15579
ISSN: 1554-8619
Copyright: open access
Appears in Collections:BA - IGM - Artigos de Periódicos

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