Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial
Autor(a) principal: | |
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Data de Publicação: | 2004 |
Outros Autores: | , , , , , , |
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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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) instacron:USP |
instname_str |
Universidade de São Paulo (USP) |
instacron_str |
USP |
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 |
_version_ |
1800221782931668992 |