Trial of the efficacy of a second dose of BCG vaccination against tuberculosis (Avaliação da eficácia da segunda dose da vacina BCG em escolares)
| ISRCTN | ISRCTN07601391 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07601391 |
| Secondary identifying numbers | R6715 |
- Submission date
- 17/01/2007
- Registration date
- 21/03/2007
- Last edited
- 15/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
The BCG vaccine protects against tuberculosis, a serious infection which affects the lungs. It has also been found to protect against leprosy, an infectious skin and nerve disease. The aim of this study is to assess the effectiveness of a second dose of BCG vaccination against tuberculosis and leprosy.
Who can participate?
Schoolchildren aged 7 to 14 years attending the participating state schools
What does the study involve?
Participating schools are randomly allocated to one of two groups: the intervention group and the control group. Participants in the intervention group schools receive a second BCG vaccination. Participants in the control group schools do not receive the second BCG vaccination. The number of cases of tuberculosis and leprosy are recorded in the two groups.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
767 state schools in the cities of Salvador and Manaus in Brazil
When is the study starting and how long is it expected to run for?
June 1996 to June 2016
Who is funding the study?
1. The Department For International Development (DFID) (UK)
2. Ministry of Health (Brazil)
Who is the main contact?
Prof. Mauricio Lima Barreto
Contact information
Scientific
Instituto de Saúde Coletiva
Universidade Federal da Bahia
Rua Basílio da Gama, s/n
Campus Universitário Canela
Salvador
40.110-040
Brazil
Study information
| Study design | Cluster randomised trial, with schools being the unit of randomisation. There was no concealment of allocation or intervention and no placebo was used. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Trial of the efficacy of a second dose of BCG vaccination against tuberculosis (Avaliação da eficácia da segunda dose da vacina BCG em escolares) |
| Study acronym | BCGREVAC |
| Study objectives | To estimate the efficacy of a second dose of BCG vaccination against tuberculosis and leprosy. |
| Ethics approval(s) | 1. Ethical Committee of the University Hospital Professor Edgard Santos (HUPES) of the Federal University of Bahia, 07/10/1996 2. National Committee for ethics in Research (Comitê Nacional de Etica em Pesquisa-CONEP), 30/10/2003, judgement ref: 770/2003, submission ref: 250000.106515/2003-02 |
| Health condition(s) or problem(s) studied | Tuberculosis and leprosy |
| Intervention | 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. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Case of tuberculosis 2. Case of leprosy |
| Secondary outcome measures | 1. Tuberculosis by form 2. Leprosy by form |
| Overall study start date | 01/06/1996 |
| Completion date | 01/06/2016 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 351,951 |
| Key inclusion criteria | School children aged 7 to 14 years in state schools |
| Key exclusion criteria | 1. Children with special needs 2. Children who received more than one BCG vaccination |
| Date of first enrolment | 01/06/1996 |
| Date of final enrolment | 01/06/2016 |
Locations
Countries of recruitment
- Brazil
Study participating centre
40.110-040
Brazil
Sponsor information
University/education
c/o Maria da Gloria Lima Cruz Teixeira
Universidade Federal da Bahia
Rua Basílio da Gamas/n
Campus Universitário Canela
Salvador
40.110-040
Brazil
| Phone | +55 (0)713 263 7414 |
|---|---|
| magloria@ufba.br | |
| Website | http://www.isc.ufba.br/isc.asp |
"ROR" |
https://ror.org/03k3p7647 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Department for International Development, UK, DFID
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2001 | Yes | No | |
| Protocol article | protocol | 01/10/2002 | Yes | No | |
| Results article | results | 01/04/2003 | Yes | No | |
| Results article | results | 01/04/2003 | Yes | No | |
| Protocol article | protocol | 01/03/2004 | Yes | No | |
| Results article | results | 01/12/2004 | Yes | No | |
| Results article | results | 01/10/2005 | Yes | No | |
| Results article | results | 08/10/2005 | Yes | No | |
| Results article | results | 24/06/2014 | Yes | No |
Editorial Notes
15/03/2016: Plain English summary added.
