Please use this identifier to cite or link to this item: http://www.arca.fiocruz.br/handle/icict/11680
Title: 17DD yellow fever vaccine A double blind, randomized clinical trial of immunogenicity and safety on a dose-response study
Authors: Martins, Reinaldo M.
Maia, Maria de Lourdes S.
Farias, Roberto Henrique G.
Camacho, Luiz Antonio B.
Freire, Marcos F.
Galler, Ricardo
Yamamura, Anna Maya Yoshida
Almeida, Luiz Fernando C.
Lima, Sheila Maria B.
Nogueira, Rita Maria R.
Sá, Glória Regina S.
Hokama, Darcy A.
Carvalho, Ricardo de
Freire, Ricardo Aguiar V.
Pereira Filho, Edson
Leal, Maria da Luz Fernandes
Homma, Akira
Affilliation: Fundação Oswaldo Cruz. Bio-Maguinhos. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Bio-Maguinhos. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Bio-Maguinhos. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sérgio Arouca. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Bio-Maguinhos. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Bio-Maguinhos. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Bio-Maguinhos. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Bio-Maguinhos. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Bio-Maguinhos. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Bio-Maguinhos. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Bio-Maguinhos. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Bio-Maguinhos. Rio de Janeiro, RJ, Brasil.
Instituto de Biologia do Exército. Rio de Janeiro, RJ, Brasil.
nstituto de Biologia do Exército. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Bio-Maguinhos. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Bio-Maguinhos. Rio de Janeiro, RJ, Brasil.
Abstract: Objective: To verify if the Bio-Manguinhos 17DD yellow fever vaccine (17DD-YFV) used in lower doses is as immunogenic and safe as the current formulation. Results: Doses from 27,476 IU to 587 IU induced similar seroconversion rates and neutralizing antibodies geometric mean titers (GMTs). Immunity of those who seroconverted to YF was maintained for 10 mo. Reactogenicity was low for all groups. Methods: Young and healthy adult males (n = 900) were recruited and randomized into 6 groups, to receive deescalating doses of 17DD-YFV, from 27,476 IU to 31 IU. Blood samples were collected before vaccination (for neutralization tests to yellow fever, serology for dengue and clinical chemistry), 3 to 7 d after vaccination (for viremia and clinical chemistry) and 30 d after vaccination (for new yellow fever serology and clinical chemistry). Adverse events diaries were filled out by volunteers during 10 d after vaccination. Volunteers were retested for yellow fever and dengue antibodies 10 mo later. Seropositivity for dengue was found in 87.6% of volunteers before vaccination, but this had no significant influence on conclusions. Conclusion: In young healthy adults Bio-Manguinhos/Fiocruz yellow fever vaccine can be used in much lower doses than usual.
Keywords: Yellow fever vaccine
Immunogenicity
Safety
Reactogenicity
Dose-response study
Viremia
DeCS: Vacina contra Febre Amarela
Segurança
Viremia
Dengue
Issue Date: 2013
Publisher: Taylor & Francis
Citation: MARTINS, Reinaldo M.; et al. 17DD yellow fever vaccine A double blind, randomized clinical trial of immunogenicity and safety on a dose-response study. Human Vaccines & Immunotherapeutics, v. 9, n.4, p.879–888, April 2013 © 2013
DOI: 10.4161/hv.22982
ISSN: 2164-554X
Copyright: restricted access
Appears in Collections:IOC - Artigos de Periódicos

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