Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial

Detalhes bibliográficos
Autor(a) principal: Camacho, Luiz Antonio Bastos
Data de Publicação: 2004
Outros Autores: Freire, Marcos da Silva, Leal, Maria da Luz Fernandes, Aguiar, Savitri Gomes de, Nascimento, Jussara Pereira do, Iguchi, Takumi, Lozana, José de Azevedo, Farias, Roberto Henrique Guedes
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Revista de Saúde Pública
Texto Completo: https://www.revistas.usp.br/rsp/article/view/31779
Resumo: OBJECTIVE: To compare the immunogenicity of three yellow fever vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots). METHODS: An equivalence trial was carried out involving 1,087 adults in Rio de Janeiro. Vaccines produced by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil) were administered following standardized procedures adapted to allow blocked randomized allocation of participants to coded vaccine types (double-blind). Neutralizing yellow fever antibody titters were compared in pre- and post-immunization serum samples. Equivalence was defined as a difference of no more than five percentage points in seroconversion rates, and ratio between Geometric Mean Titters (GMT) higher than 0.67. RESULTS: Seroconversion rates were 98% or higher among subjects previously seronegative, and 90% or more of the total cohort of vaccinees, including those previously seropositive. Differences in seroconversion ranged from -0.05% to -3.02%. The intensity of the immune response was also very similar across vaccines: 14.5 to 18.6 IU/mL. GMT ratios ranged from 0.78 to 0.93. Taking the placebo group into account, the vaccines explained 93% of seroconversion. Viremia was detected in 2.7% of vaccinated subjects from Day 3 to Day 7. CONCLUSIONS: The equivalent immunogenicity of yellow fever vaccines from the 17D and 17DD substrains was demonstrated for the first time in placebo-controlled double-blind randomized trial. The study completed the clinical validation process of a new vaccine seed-lot, provided evidence for use of alternative attenuated virus substrains in vaccine production for a major manufacturer, and for the utilization of the 17DD vaccine in other countries.
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spelling Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial Imunogenicidade das vacinas contra febre amarela WHO-17D e 17DD: ensaio randomizado Vacina contra febre amarelaEnsaios controlados aleatóriosYellow fever vaccineRandomized controlled trials OBJECTIVE: To compare the immunogenicity of three yellow fever vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots). METHODS: An equivalence trial was carried out involving 1,087 adults in Rio de Janeiro. Vaccines produced by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil) were administered following standardized procedures adapted to allow blocked randomized allocation of participants to coded vaccine types (double-blind). Neutralizing yellow fever antibody titters were compared in pre- and post-immunization serum samples. Equivalence was defined as a difference of no more than five percentage points in seroconversion rates, and ratio between Geometric Mean Titters (GMT) higher than 0.67. RESULTS: Seroconversion rates were 98% or higher among subjects previously seronegative, and 90% or more of the total cohort of vaccinees, including those previously seropositive. Differences in seroconversion ranged from -0.05% to -3.02%. The intensity of the immune response was also very similar across vaccines: 14.5 to 18.6 IU/mL. GMT ratios ranged from 0.78 to 0.93. Taking the placebo group into account, the vaccines explained 93% of seroconversion. Viremia was detected in 2.7% of vaccinated subjects from Day 3 to Day 7. CONCLUSIONS: The equivalent immunogenicity of yellow fever vaccines from the 17D and 17DD substrains was demonstrated for the first time in placebo-controlled double-blind randomized trial. The study completed the clinical validation process of a new vaccine seed-lot, provided evidence for use of alternative attenuated virus substrains in vaccine production for a major manufacturer, and for the utilization of the 17DD vaccine in other countries. OBJETIVO: Comparar a imunogenicidade de três vacinas contra febre amarela ) das subcepas WHO-17D e 17DD brasileira (diferentes lotes-semente). MÉTODOS: Trata-se de ensaio de equivalência envolvendo 1.087 adultos no Rio de Janeiro, RJ. As vacinas foram produzidas em Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brasil) e foram administradas seguindo procedimentos adaptados para randomização em blocos, com tipos de vacinas codificados ("duplo-cego"). Anticorpos neutralizantes contra febre amarela foram dosados antes e depois da vacinação. Definiu-se equivalência como diferença nas taxas de soroconversão não superior a cinco pontos percentuais, e razão de títulos médios geométricos superior (TMG) a 0,67. RESULTADOS: As taxas de soroconversão foram iguais ou maiores do que 98% nos participantes previamente soronegativos. Na coorte completa (incluindo os previamente soropositivos) a soroconversão foi igual ou superior a 90%. As diferenças na soroconversão variaram de -0,05% a -3,02% entre os grupos de comparação. A intensidade da resposta imune também foi semelhante nos grupos: 14,5 UI/mL a 18,6 UI/mL. As razões de TMG variaram de 0,78 a 0,93. Considerando o grupo placebo, as vacinas explicaram 93% da soroconversão. Viremia foi detectada entre os dias três e sete em 2,7% dos participantes vacinados. CONCLUSÕES: A equivalência na imunogenicidade das vacinas contra a febre amarela das subcepas 17D e 17DD foi demonstrada pela primeira vez em ensaio clínico randomizado, duplo-cego, controlado com placebo. O estudo completou o processo de validação clínica do novo lote-semente de vacina, além de ampliar as bases para utilização da vacina brasileira em outros países e de trazer alternativas de subcepas para o produtor da vacina no Brasil. Universidade de São Paulo. Faculdade de Saúde Pública2004-10-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.revistas.usp.br/rsp/article/view/3177910.1590/S0034-89102004000500009Revista de Saúde Pública; Vol. 38 No. 5 (2004); 671-678 Revista de Saúde Pública; Vol. 38 Núm. 5 (2004); 671-678 Revista de Saúde Pública; v. 38 n. 5 (2004); 671-678 1518-87870034-8910reponame:Revista de Saúde Públicainstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/rsp/article/view/31779/33706Copyright (c) 2017 Revista de Saúde Públicainfo:eu-repo/semantics/openAccessCamacho, Luiz Antonio BastosFreire, Marcos da SilvaLeal, Maria da Luz FernandesAguiar, Savitri Gomes deNascimento, Jussara Pereira doIguchi, TakumiLozana, José de AzevedoFarias, Roberto Henrique Guedes2012-07-08T22:10:39Zoai:revistas.usp.br:article/31779Revistahttps://www.revistas.usp.br/rsp/indexONGhttps://www.revistas.usp.br/rsp/oairevsp@org.usp.br||revsp1@usp.br1518-87870034-8910opendoar:2012-07-08T22:10:39Revista de Saúde Pública - Universidade de São Paulo (USP)false
dc.title.none.fl_str_mv Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial
Imunogenicidade das vacinas contra febre amarela WHO-17D e 17DD: ensaio randomizado
title Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial
spellingShingle Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial
Camacho, Luiz Antonio Bastos
Vacina contra febre amarela
Ensaios controlados aleatórios
Yellow fever vaccine
Randomized controlled trials
title_short Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial
title_full Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial
title_fullStr Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial
title_full_unstemmed Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial
title_sort Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial
author Camacho, Luiz Antonio Bastos
author_facet Camacho, Luiz Antonio Bastos
Freire, Marcos da Silva
Leal, Maria da Luz Fernandes
Aguiar, Savitri Gomes de
Nascimento, Jussara Pereira do
Iguchi, Takumi
Lozana, José de Azevedo
Farias, Roberto Henrique Guedes
author_role author
author2 Freire, Marcos da Silva
Leal, Maria da Luz Fernandes
Aguiar, Savitri Gomes de
Nascimento, Jussara Pereira do
Iguchi, Takumi
Lozana, José de Azevedo
Farias, Roberto Henrique Guedes
author2_role author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Camacho, Luiz Antonio Bastos
Freire, Marcos da Silva
Leal, Maria da Luz Fernandes
Aguiar, Savitri Gomes de
Nascimento, Jussara Pereira do
Iguchi, Takumi
Lozana, José de Azevedo
Farias, Roberto Henrique Guedes
dc.subject.por.fl_str_mv Vacina contra febre amarela
Ensaios controlados aleatórios
Yellow fever vaccine
Randomized controlled trials
topic Vacina contra febre amarela
Ensaios controlados aleatórios
Yellow fever vaccine
Randomized controlled trials
description OBJECTIVE: To compare the immunogenicity of three yellow fever vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots). METHODS: An equivalence trial was carried out involving 1,087 adults in Rio de Janeiro. Vaccines produced by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil) were administered following standardized procedures adapted to allow blocked randomized allocation of participants to coded vaccine types (double-blind). Neutralizing yellow fever antibody titters were compared in pre- and post-immunization serum samples. Equivalence was defined as a difference of no more than five percentage points in seroconversion rates, and ratio between Geometric Mean Titters (GMT) higher than 0.67. RESULTS: Seroconversion rates were 98% or higher among subjects previously seronegative, and 90% or more of the total cohort of vaccinees, including those previously seropositive. Differences in seroconversion ranged from -0.05% to -3.02%. The intensity of the immune response was also very similar across vaccines: 14.5 to 18.6 IU/mL. GMT ratios ranged from 0.78 to 0.93. Taking the placebo group into account, the vaccines explained 93% of seroconversion. Viremia was detected in 2.7% of vaccinated subjects from Day 3 to Day 7. CONCLUSIONS: The equivalent immunogenicity of yellow fever vaccines from the 17D and 17DD substrains was demonstrated for the first time in placebo-controlled double-blind randomized trial. The study completed the clinical validation process of a new vaccine seed-lot, provided evidence for use of alternative attenuated virus substrains in vaccine production for a major manufacturer, and for the utilization of the 17DD vaccine in other countries.
publishDate 2004
dc.date.none.fl_str_mv 2004-10-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://www.revistas.usp.br/rsp/article/view/31779
10.1590/S0034-89102004000500009
url https://www.revistas.usp.br/rsp/article/view/31779
identifier_str_mv 10.1590/S0034-89102004000500009
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv https://www.revistas.usp.br/rsp/article/view/31779/33706
dc.rights.driver.fl_str_mv Copyright (c) 2017 Revista de Saúde Pública
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2017 Revista de Saúde Pública
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidade de São Paulo. Faculdade de Saúde Pública
publisher.none.fl_str_mv Universidade de São Paulo. Faculdade de Saúde Pública
dc.source.none.fl_str_mv Revista de Saúde Pública; Vol. 38 No. 5 (2004); 671-678
Revista de Saúde Pública; Vol. 38 Núm. 5 (2004); 671-678
Revista de Saúde Pública; v. 38 n. 5 (2004); 671-678
1518-8787
0034-8910
reponame:Revista de Saúde Pública
instname:Universidade de São Paulo (USP)
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instname_str Universidade de São Paulo (USP)
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institution USP
reponame_str Revista de Saúde Pública
collection Revista de Saúde Pública
repository.name.fl_str_mv Revista de Saúde Pública - Universidade de São Paulo (USP)
repository.mail.fl_str_mv revsp@org.usp.br||revsp1@usp.br
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