Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B
Autor(a) principal: | |
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Data de Publicação: | 2004 |
Outros Autores: | , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Digital do Instituto Evandro Chagas (Patuá) |
Texto Completo: | https://patua.iec.gov.br/handle/iec/1022 |
Resumo: | The immunogenicity and safety of a new recombinant hepatitis B vaccine from the Instituto Butantan (Butang®) were evaluated in a multicenter, double-blind, prospective equivalence study in three centers in Brazil. Engerix B® was the standard vaccine. A total of 3937 subjects were recruited and 2754 (70%) met all protocol criteria at the end of the study. All the subjects were considered healthy and denied having received hepatitis B vaccine before the study. Study subjects who adhered to the protocol were newborn infants (566), children 1 to 10 years old (484), adolescents from 11 to 19 years (740), adults from 20 to 30 years (568), and adults from 31 to 40 years (396). Vaccine was administered in three doses on the schedule 0, 1, and 6 months (newborn infants, adolescents, and adults) or 0, 1, and 7 months (children). Vaccine dose was intramuscular 10 µg (infants, children, and adolescents) or 20 µg (adults). Percent seroprotection (assumed when anti-HBs titers were ≥ 10mIU/ml) and geometric mean titer (mIU/ml) were: newborn infants, 93.7% and 351.1 (Butang®) and 97.5% and 1530.6 (Engerix B®); children, 100% and 3600.0 (Butang®) and 97.7% and 2753.1 (Engerix B®); adolescents, 95.1% and 746.3 (Butang®) and 96% and 1284.3 (Engerix B®); adults 20-30 years old, 91.8% and 453.5 (Butang®) and 95.5% and 1369.0 (Engerix B®); and adults 31-40 years old, 79.8% and 122.7 (Butang®) and 92.4% and 686.2 (Engerix B®). There were no severe adverse events following either vaccine. The study concluded that Butang® was equivalent to Engerix B® in children, and less immunogenic but acceptable for use in newborn infants, adolescents, and young adults. |
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Martins, Reinaldo MenezesBensabath, GilbertaArraes, Luiz ClaudioOliveira, Maria de Lourdes AguiarMiguel, Juliana CustódioBarbosa, Glayse GlaydeCamacho, Luiz Antonio Bastos2016-01-26T11:41:59Z2016-01-26T11:41:59Z2004MARTINS, Reinaldo Menezes et al. Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B. Memórias do Instituto Oswaldo Cruz, v. 99, n. 8, p. 865-871, Dec. 20040074-0276https://patua.iec.gov.br/handle/iec/1022The immunogenicity and safety of a new recombinant hepatitis B vaccine from the Instituto Butantan (Butang®) were evaluated in a multicenter, double-blind, prospective equivalence study in three centers in Brazil. Engerix B® was the standard vaccine. A total of 3937 subjects were recruited and 2754 (70%) met all protocol criteria at the end of the study. All the subjects were considered healthy and denied having received hepatitis B vaccine before the study. Study subjects who adhered to the protocol were newborn infants (566), children 1 to 10 years old (484), adolescents from 11 to 19 years (740), adults from 20 to 30 years (568), and adults from 31 to 40 years (396). Vaccine was administered in three doses on the schedule 0, 1, and 6 months (newborn infants, adolescents, and adults) or 0, 1, and 7 months (children). Vaccine dose was intramuscular 10 µg (infants, children, and adolescents) or 20 µg (adults). Percent seroprotection (assumed when anti-HBs titers were ≥ 10mIU/ml) and geometric mean titer (mIU/ml) were: newborn infants, 93.7% and 351.1 (Butang®) and 97.5% and 1530.6 (Engerix B®); children, 100% and 3600.0 (Butang®) and 97.7% and 2753.1 (Engerix B®); adolescents, 95.1% and 746.3 (Butang®) and 96% and 1284.3 (Engerix B®); adults 20-30 years old, 91.8% and 453.5 (Butang®) and 95.5% and 1369.0 (Engerix B®); and adults 31-40 years old, 79.8% and 122.7 (Butang®) and 92.4% and 686.2 (Engerix B®). There were no severe adverse events following either vaccine. The study concluded that Butang® was equivalent to Engerix B® in children, and less immunogenic but acceptable for use in newborn infants, adolescents, and young adults.Ministério da Saúde. Secretaria de Vigilância em Saúde. Comitê Técnico Assessor em Imunizações. Rio de Janeiro, RJ, Brasil.Ministério da Saúde. Secretaria de Vigilância em Saúde. Instituto Evandro Chagas. Belém, PA, Brasil.Instituto Materno-Infantil de Pernambuco. Recife, PE, Brasil.Instituto Oswaldo Cruz. Centro de Referência Nacional de Hepatites Virais. Departamento de Virologia. Rio de Janeiro, RJ, Brasil.Instituto Oswaldo Cruz. Centro de Referência Nacional de Hepatites Virais. Departamento de Virologia. Rio de Janeiro, RJ, Brasil.Lar de Frei Luiz. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. 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dc.title.pt_BR.fl_str_mv |
Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B |
title |
Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B |
spellingShingle |
Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B Martins, Reinaldo Menezes Vacinas contra Hepatite B / administração & dosagem Vacinas contra Hepatite B / uso terapêutico Vacinas Sintéticas / uso terapêutico Brazil (BR) |
title_short |
Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B |
title_full |
Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B |
title_fullStr |
Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B |
title_full_unstemmed |
Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B |
title_sort |
Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B |
author |
Martins, Reinaldo Menezes |
author_facet |
Martins, Reinaldo Menezes Bensabath, Gilberta Arraes, Luiz Claudio Oliveira, Maria de Lourdes Aguiar Miguel, Juliana Custódio Barbosa, Glayse Glayde Camacho, Luiz Antonio Bastos |
author_role |
author |
author2 |
Bensabath, Gilberta Arraes, Luiz Claudio Oliveira, Maria de Lourdes Aguiar Miguel, Juliana Custódio Barbosa, Glayse Glayde Camacho, Luiz Antonio Bastos |
author2_role |
author author author author author author |
dc.contributor.author.fl_str_mv |
Martins, Reinaldo Menezes Bensabath, Gilberta Arraes, Luiz Claudio Oliveira, Maria de Lourdes Aguiar Miguel, Juliana Custódio Barbosa, Glayse Glayde Camacho, Luiz Antonio Bastos |
dc.subject.decsPrimary.pt_BR.fl_str_mv |
Vacinas contra Hepatite B / administração & dosagem Vacinas contra Hepatite B / uso terapêutico Vacinas Sintéticas / uso terapêutico Brazil (BR) |
topic |
Vacinas contra Hepatite B / administração & dosagem Vacinas contra Hepatite B / uso terapêutico Vacinas Sintéticas / uso terapêutico Brazil (BR) |
description |
The immunogenicity and safety of a new recombinant hepatitis B vaccine from the Instituto Butantan (Butang®) were evaluated in a multicenter, double-blind, prospective equivalence study in three centers in Brazil. Engerix B® was the standard vaccine. A total of 3937 subjects were recruited and 2754 (70%) met all protocol criteria at the end of the study. All the subjects were considered healthy and denied having received hepatitis B vaccine before the study. Study subjects who adhered to the protocol were newborn infants (566), children 1 to 10 years old (484), adolescents from 11 to 19 years (740), adults from 20 to 30 years (568), and adults from 31 to 40 years (396). Vaccine was administered in three doses on the schedule 0, 1, and 6 months (newborn infants, adolescents, and adults) or 0, 1, and 7 months (children). Vaccine dose was intramuscular 10 µg (infants, children, and adolescents) or 20 µg (adults). Percent seroprotection (assumed when anti-HBs titers were ≥ 10mIU/ml) and geometric mean titer (mIU/ml) were: newborn infants, 93.7% and 351.1 (Butang®) and 97.5% and 1530.6 (Engerix B®); children, 100% and 3600.0 (Butang®) and 97.7% and 2753.1 (Engerix B®); adolescents, 95.1% and 746.3 (Butang®) and 96% and 1284.3 (Engerix B®); adults 20-30 years old, 91.8% and 453.5 (Butang®) and 95.5% and 1369.0 (Engerix B®); and adults 31-40 years old, 79.8% and 122.7 (Butang®) and 92.4% and 686.2 (Engerix B®). There were no severe adverse events following either vaccine. The study concluded that Butang® was equivalent to Engerix B® in children, and less immunogenic but acceptable for use in newborn infants, adolescents, and young adults. |
publishDate |
2004 |
dc.date.issued.fl_str_mv |
2004 |
dc.date.accessioned.fl_str_mv |
2016-01-26T11:41:59Z |
dc.date.available.fl_str_mv |
2016-01-26T11:41:59Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
MARTINS, Reinaldo Menezes et al. Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B. Memórias do Instituto Oswaldo Cruz, v. 99, n. 8, p. 865-871, Dec. 2004 |
dc.identifier.uri.fl_str_mv |
https://patua.iec.gov.br/handle/iec/1022 |
dc.identifier.issn.-.fl_str_mv |
0074-0276 |
identifier_str_mv |
MARTINS, Reinaldo Menezes et al. Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B. Memórias do Instituto Oswaldo Cruz, v. 99, n. 8, p. 865-871, Dec. 2004 0074-0276 |
url |
https://patua.iec.gov.br/handle/iec/1022 |
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eng |
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eng |
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info:eu-repo/semantics/openAccess |
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openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Instituto Oswaldo Cruz |
publisher.none.fl_str_mv |
Instituto Oswaldo Cruz |
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reponame:Repositório Digital do Instituto Evandro Chagas (Patuá) instname:Instituto Evandro Chagas (IEC) instacron:IEC |
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IEC |
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IEC |
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Repositório Digital do Instituto Evandro Chagas (Patuá) |
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Repositório Digital do Instituto Evandro Chagas (Patuá) |
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