Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial
Autor(a) principal: | |
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Data de Publicação: | 2005 |
Outros Autores: | , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Revista de Saúde Pública |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102005000300012 |
Resumo: | OBJECTIVE: To compare the reactogenicity of three yellow fever (YF) vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots) and placebo. METHODS: The study involved 1,087 adults eligible for YF vaccine in Rio de Janeiro, Brazil. Vaccines produced by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil) were administered ("day 0") following standardized procedures adapted to allow blinding and blocked randomization of participants to coded vaccine types. Adverse events after immunization were ascertained in an interview and in diary forms filled in by each participant. Liver enzymes were measured on days 0, 4-20 and 30 of the study. Viremia levels were measured on days 4 to 20 of follow-up. The immune response was verified through serologic tests. RESULTS: Participants were mostly young males. The seroconversion rate was above 98% among those seronegative before immunization. Compared to placebo, the excess risk of any local adverse events ranged from 0.9% to 2.5%, whereas for any systemic adverse events it ranged from 3.5% to 7.4% across vaccine groups. The excess risk of events leading to search for medical care or to interruption of work activities ranged from 2% to 4.5%. Viremia was detected in 3%-6% of vaccinees up to 10 days after vaccination. Variations in liver enzyme levels after vaccination were similar in placebo and vaccine recipients. CONCLUSIONS: The frequency of adverse events post-immunization against YF, accounting for the background occurrence of nonspecific signs and symptoms, was shown for the first time to be similar for vaccines from 17D and 17DD substrains. The data also provided evidence against viscerotropism of vaccine virus. |
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Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trialYellow fever vaccineRandomized controlled trialsAdverses effectsBrazilOBJECTIVE: To compare the reactogenicity of three yellow fever (YF) vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots) and placebo. METHODS: The study involved 1,087 adults eligible for YF vaccine in Rio de Janeiro, Brazil. Vaccines produced by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil) were administered ("day 0") following standardized procedures adapted to allow blinding and blocked randomization of participants to coded vaccine types. Adverse events after immunization were ascertained in an interview and in diary forms filled in by each participant. Liver enzymes were measured on days 0, 4-20 and 30 of the study. Viremia levels were measured on days 4 to 20 of follow-up. The immune response was verified through serologic tests. RESULTS: Participants were mostly young males. The seroconversion rate was above 98% among those seronegative before immunization. Compared to placebo, the excess risk of any local adverse events ranged from 0.9% to 2.5%, whereas for any systemic adverse events it ranged from 3.5% to 7.4% across vaccine groups. The excess risk of events leading to search for medical care or to interruption of work activities ranged from 2% to 4.5%. Viremia was detected in 3%-6% of vaccinees up to 10 days after vaccination. Variations in liver enzyme levels after vaccination were similar in placebo and vaccine recipients. CONCLUSIONS: The frequency of adverse events post-immunization against YF, accounting for the background occurrence of nonspecific signs and symptoms, was shown for the first time to be similar for vaccines from 17D and 17DD substrains. The data also provided evidence against viscerotropism of vaccine virus.Faculdade de Saúde Pública da Universidade de São Paulo2005-06-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102005000300012Revista de Saúde Pública v.39 n.3 2005reponame:Revista de Saúde Públicainstname:Universidade de São Paulo (USP)instacron:USP10.1590/S0034-89102005000300012info:eu-repo/semantics/openAccessCamacho,Luiz Antonio BastosAguiar,Savitri Gomes deFreire,Marcos da SilvaLeal,Maria da Luz FernandesNascimento,Jussara Pereira doIguchi,TakumiLozana,José AzevedoFarias,Roberto Henrique Guedeseng2005-06-30T00:00:00Zoai:scielo:S0034-89102005000300012Revistahttp://www.scielo.br/scielo.php?script=sci_serial&pid=0034-8910&lng=pt&nrm=isoONGhttps://old.scielo.br/oai/scielo-oai.phprevsp@org.usp.br||revsp1@usp.br1518-87870034-8910opendoar:2005-06-30T00:00Revista de Saúde Pública - Universidade de São Paulo (USP)false |
dc.title.none.fl_str_mv |
Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial |
title |
Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial |
spellingShingle |
Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial Camacho,Luiz Antonio Bastos Yellow fever vaccine Randomized controlled trials Adverses effects Brazil |
title_short |
Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial |
title_full |
Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial |
title_fullStr |
Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial |
title_full_unstemmed |
Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial |
title_sort |
Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial |
author |
Camacho,Luiz Antonio Bastos |
author_facet |
Camacho,Luiz Antonio Bastos Aguiar,Savitri Gomes de Freire,Marcos da Silva Leal,Maria da Luz Fernandes Nascimento,Jussara Pereira do Iguchi,Takumi Lozana,José Azevedo Farias,Roberto Henrique Guedes |
author_role |
author |
author2 |
Aguiar,Savitri Gomes de Freire,Marcos da Silva Leal,Maria da Luz Fernandes Nascimento,Jussara Pereira do Iguchi,Takumi Lozana,José Azevedo Farias,Roberto Henrique Guedes |
author2_role |
author author author author author author author |
dc.contributor.author.fl_str_mv |
Camacho,Luiz Antonio Bastos Aguiar,Savitri Gomes de Freire,Marcos da Silva Leal,Maria da Luz Fernandes Nascimento,Jussara Pereira do Iguchi,Takumi Lozana,José Azevedo Farias,Roberto Henrique Guedes |
dc.subject.por.fl_str_mv |
Yellow fever vaccine Randomized controlled trials Adverses effects Brazil |
topic |
Yellow fever vaccine Randomized controlled trials Adverses effects Brazil |
description |
OBJECTIVE: To compare the reactogenicity of three yellow fever (YF) vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots) and placebo. METHODS: The study involved 1,087 adults eligible for YF vaccine in Rio de Janeiro, Brazil. Vaccines produced by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil) were administered ("day 0") following standardized procedures adapted to allow blinding and blocked randomization of participants to coded vaccine types. Adverse events after immunization were ascertained in an interview and in diary forms filled in by each participant. Liver enzymes were measured on days 0, 4-20 and 30 of the study. Viremia levels were measured on days 4 to 20 of follow-up. The immune response was verified through serologic tests. RESULTS: Participants were mostly young males. The seroconversion rate was above 98% among those seronegative before immunization. Compared to placebo, the excess risk of any local adverse events ranged from 0.9% to 2.5%, whereas for any systemic adverse events it ranged from 3.5% to 7.4% across vaccine groups. The excess risk of events leading to search for medical care or to interruption of work activities ranged from 2% to 4.5%. Viremia was detected in 3%-6% of vaccinees up to 10 days after vaccination. Variations in liver enzyme levels after vaccination were similar in placebo and vaccine recipients. CONCLUSIONS: The frequency of adverse events post-immunization against YF, accounting for the background occurrence of nonspecific signs and symptoms, was shown for the first time to be similar for vaccines from 17D and 17DD substrains. The data also provided evidence against viscerotropism of vaccine virus. |
publishDate |
2005 |
dc.date.none.fl_str_mv |
2005-06-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102005000300012 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102005000300012 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.1590/S0034-89102005000300012 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Faculdade de Saúde Pública da Universidade de São Paulo |
publisher.none.fl_str_mv |
Faculdade de Saúde Pública da Universidade de São Paulo |
dc.source.none.fl_str_mv |
Revista de Saúde Pública v.39 n.3 2005 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_ |
1748936494646558720 |