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ISRCTN
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ISRCTN07601391
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ClinicalTrials.gov identifier
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Public title
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Trial of the efficacy of a second dose of BCG vaccination against tuberculosis (Avaliação da eficácia da segunda dose da vacina BCG em escolares)
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Scientific title
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Acronym
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BCGREVAC
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Serial number at source
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R6715
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Study hypothesis
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To estimate the efficacy of a second dose of BCG vaccination against tuberculosis and leprosy.
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Lay summary
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Ethics approval
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Approval received from the Ethical Committee of the University Hospital Professor Edgard Santos (HUPES), of the Federal University of Bahia on the 7th October 1996. The leprosy component has an additional ethical approval, by the National Committee for ethics in Research (Comitê Nacional de Etica em Pesquisa-CONEP), on the 30th October 2003 (judgement ref: 770/2003, submission ref: 250000.106515/2003-02).
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Study design
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Cluster randomised trial, with schools being the unit of randomisation. There was no concealment of allocation or intervention and no placebo was used.
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Countries of recruitment
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Brazil
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Disease/condition/study domain
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Tuberculosis and leprosy
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Participants - inclusion criteria
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School children aged seven to 14 years in state schools
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Participants - exclusion criteria
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1. Children with special needs
2. Children who received more than one BCG vaccination
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Anticipated start date
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01/06/1996
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Anticipated end date
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01/06/2016
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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351,951
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Interventions
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The intervention was a single intradermal injection with BCG vaccine produced in Brazil using the Moreaux (Rio de Janeiro) strain. This will be a revaccination as children have a high coverage of BCG at birth. The control group will receive no vaccination.
The trial was conducted in two sites, the cities of Salvador and Manaus, in Brazil. Seven hundred and sixty seven state schools were included in the trial. Children in both treatment groups were visited at school to confirm their identification details and their arms were examined for BCG scars. Ascertainment of cases was through the tuberculosis control programme. Cases notified were reviewed independently by two chest physicians, who classified cases into confirmed (microbiological confirmation), probable (would treat based on the information from the records), suspected (no information in the record suggested this was not tuberculosis) and not tuberculosis (excluded from the analysis), and into pulmonary and non-pulmonary forms. A third specialist reviewed those classified differently by the two chest physicians. The validation was blind to vaccination.
Cases were linked to the study population in the study database. Linkage was done blind to vaccination status, based on the name of the child, the name of the mother, the sex and date of birth of the child. All possible matches were reviewed by a member of the study team to assess its reliability. Most were unique matches, with complete concordance on all variables. Home visits to a sample of cases not linked to the database identified only two cases (out of 144 visited) that belonged to the database.
Active informed consent was not obtained. This was because both intervention (BCG revaccination) and absence of intervention were in routine practice in different settings in Brazil at the time, and therefore an "opt out" form of consent was deemed acceptable: parents of children in schools allocated to vaccination were given written information about the vaccine and the trial and offered the opportunity to withdraw their child from the trial.
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Primary outcome measure(s)
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1. Case of tuberculosis
2. Case of leprosy
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Secondary outcome measure(s)
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1. Tuberculosis by form
2. Leprosy by form
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Sources of funding
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1. The Department For International Development (DFID) (UK)
2. Brazil Ministry of Health (Brazil)
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Trial website
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Publications
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Protocols:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=12392870
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15217320
Results:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16214599
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=12729348
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15682973
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16229231
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=11716343
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=12700850
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Contact name
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Prof
Mauricio Lima
Barreto
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Address
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Instituto de Saúde Coletiva
Universidade Federal da Bahia
Rua Basílio da Gama, s/n
Campus Universitário Canela
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City/town
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Salvador
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Zip/Postcode
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40.110-040
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Country
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Brazil
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Sponsor
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Institute for Collective Health (Instituto de Saúde Coletiva) (Brazil)
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Address
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c/o Maria da Gloria Lima Cruz Teixeira
Universidade Federal da Bahia
Rua Basílio da Gamas/n
Campus Universitário Canela
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City/town
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Salvador
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Zip/Postcode
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40.110-040
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Country
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Brazil
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Tel
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+55 (71)3 263 7414
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Fax
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+55 (71)3 263 7414
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Email
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magloria@ufba.br
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Sponsor website:
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http://www.isc.ufba.br/isc.asp
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Date applied
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17/01/2007
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Last edited
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21/03/2007
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Date ISRCTN assigned
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21/03/2007
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