Design of the Brazilian BCG-REVAC trial against tuberculosis: a large, simple randomized community trial to evaluate the impact on tuberculosis of BCG revaccination at school age

Detalhes bibliográficos
Autor(a) principal: Barreto, Mauricio Lima
Data de Publicação: 2002
Outros Autores: Rodrigues, Laura C., Cunha, Sérgio Souza da, Pereira, Susan, Hijjar, Miguel A., Ichihara, Maria Yury, Brito, Silvana Castro de, Dourado, Maria Inês Costa
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFBA
Texto Completo: http://www.repositorio.ufba.br/ri/handle/ri/7518
Resumo: Texto completo: acesso restrito. p. 540–553
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spelling Barreto, Mauricio LimaRodrigues, Laura C.Cunha, Sérgio Souza daPereira, SusanHijjar, Miguel A.Ichihara, Maria YuryBrito, Silvana Castro deDourado, Maria Inês CostaBarreto, Mauricio LimaRodrigues, Laura C.Cunha, Sérgio Souza daPereira, SusanHijjar, Miguel A.Ichihara, Maria YuryBrito, Silvana Castro deDourado, Maria Inês Costa2012-12-14T10:41:37Z20020197-2456http://www.repositorio.ufba.br/ri/handle/ri/7518v. 23, n. 5Texto completo: acesso restrito. p. 540–553This paper describes the design and baseline results of a large and simple randomized controlled trial of the protection against tuberculosis of a dose of Bacillus Calmette Guerin (BCG) vaccination given to school children in a population with a high coverage of neonatal BCG (The Brazilian BCG-REVAC trial). The study started in 1996 and is a pair-matched and stratified-cluster randomized controlled trial with no placebo. The study population consists of children aged 7–14 years enrolled in 763 state schools from the cities of Salvador and Manaus, Brazil. Schools were the unit of randomization. Identifying information was collected for 354,708 school children. The final study population, after exclusions on the basis of age, BCG scar readings and absence from school on the day of the study visit, consists of 242,401 children, of whom 125,403 are in intervention schools. Follow-up relies on ascertainment of cases diagnosed at the health services and notified to the tuberculosis control program surveillance system. Blindness is guaranteed during linkage and validation of cases. Analysis is planned for the next 12 months, where efficacy will be estimated by calculating incidence of tuberculosis in the vaccine and control groups, taking into consideration the cluster design. The intervention studied, a second BCG vaccination, is widely used, although the World Health Organization does not recommend it on the basis of absence of evidence of protection or lack of protection. The results of the trial will make it possible for BCG revaccination practice to be informed by evidence. This is an example of a large simple and relatively inexpensive effectiveness trial, resulting from good collaboration between academia and health and education services enabling developing countries to define policies that are relevant for their reality.Submitted by Suelen Reis (suelen_suzane@hotmail.com) on 2012-12-14T10:41:37Z No. of bitstreams: 1 1-s2.0-S0197245602002167-main.pdf: 183560 bytes, checksum: cf52579b2c114d28d3c3873ca0a37e72 (MD5)Made available in DSpace on 2012-12-14T10:41:37Z (GMT). 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dc.title.pt_BR.fl_str_mv Design of the Brazilian BCG-REVAC trial against tuberculosis: a large, simple randomized community trial to evaluate the impact on tuberculosis of BCG revaccination at school age
dc.title.alternative.pt_BR.fl_str_mv Controlled Clinical Trials
title Design of the Brazilian BCG-REVAC trial against tuberculosis: a large, simple randomized community trial to evaluate the impact on tuberculosis of BCG revaccination at school age
spellingShingle Design of the Brazilian BCG-REVAC trial against tuberculosis: a large, simple randomized community trial to evaluate the impact on tuberculosis of BCG revaccination at school age
Barreto, Mauricio Lima
BCG
Bacillus Calmette-Guerin
Revaccination
Protective effect
Cluster randomization
Tuberculosis
Randomized clinical trial
Brazil
title_short Design of the Brazilian BCG-REVAC trial against tuberculosis: a large, simple randomized community trial to evaluate the impact on tuberculosis of BCG revaccination at school age
title_full Design of the Brazilian BCG-REVAC trial against tuberculosis: a large, simple randomized community trial to evaluate the impact on tuberculosis of BCG revaccination at school age
title_fullStr Design of the Brazilian BCG-REVAC trial against tuberculosis: a large, simple randomized community trial to evaluate the impact on tuberculosis of BCG revaccination at school age
title_full_unstemmed Design of the Brazilian BCG-REVAC trial against tuberculosis: a large, simple randomized community trial to evaluate the impact on tuberculosis of BCG revaccination at school age
title_sort Design of the Brazilian BCG-REVAC trial against tuberculosis: a large, simple randomized community trial to evaluate the impact on tuberculosis of BCG revaccination at school age
author Barreto, Mauricio Lima
author_facet Barreto, Mauricio Lima
Rodrigues, Laura C.
Cunha, Sérgio Souza da
Pereira, Susan
Hijjar, Miguel A.
Ichihara, Maria Yury
Brito, Silvana Castro de
Dourado, Maria Inês Costa
author_role author
author2 Rodrigues, Laura C.
Cunha, Sérgio Souza da
Pereira, Susan
Hijjar, Miguel A.
Ichihara, Maria Yury
Brito, Silvana Castro de
Dourado, Maria Inês Costa
author2_role author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Barreto, Mauricio Lima
Rodrigues, Laura C.
Cunha, Sérgio Souza da
Pereira, Susan
Hijjar, Miguel A.
Ichihara, Maria Yury
Brito, Silvana Castro de
Dourado, Maria Inês Costa
Barreto, Mauricio Lima
Rodrigues, Laura C.
Cunha, Sérgio Souza da
Pereira, Susan
Hijjar, Miguel A.
Ichihara, Maria Yury
Brito, Silvana Castro de
Dourado, Maria Inês Costa
dc.subject.por.fl_str_mv BCG
Bacillus Calmette-Guerin
Revaccination
Protective effect
Cluster randomization
Tuberculosis
Randomized clinical trial
Brazil
topic BCG
Bacillus Calmette-Guerin
Revaccination
Protective effect
Cluster randomization
Tuberculosis
Randomized clinical trial
Brazil
description Texto completo: acesso restrito. p. 540–553
publishDate 2002
dc.date.issued.fl_str_mv 2002
dc.date.accessioned.fl_str_mv 2012-12-14T10:41:37Z
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dc.identifier.issn.none.fl_str_mv 0197-2456
dc.identifier.number.pt_BR.fl_str_mv v. 23, n. 5
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