Effect of BCG vaccination for tuberculosis on COVID-19 in Brazil
| ISRCTN | ISRCTN47802196 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47802196 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 401624/2020-0 (CNPq protocol number) |
| Sponsor | National Council for Scientific and Technological Development |
| Funder | National Council for Scientific and Technological Development (CNPq) |
- Submission date
- 18/03/2021
- Registration date
- 19/05/2021
- Last edited
- 19/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Bacillus Calmette–Guérin vaccine is a vaccine primarily used against tuberculosis. It is partly named after its inventors Albert Calmette and Camille Guérin. In countries where tuberculosis or leprosy is common, one dose is recommended in healthy babies as close to the time of birth as possible.
This study aimed to estimate and to compare the occurrence and severity of COVID-19 among vaccinated (neonatal BCG vaccination) and revaccinated (neonatal BCG and a second dose of BCG vaccination at school age) in the trial BCGREVAC carried out in 763 state schools located in two Brazilian cities (Salvador and Manaus) during 1996-1998.
Who can participate?
Participants from the BCGREVAC trial (1996 - 1998) who were diagnosed or died from COVID-19 from January 27, 2020, onwards.
What does the study involve?
Records from 200,805 participants from the BCGREVAC trial will be linked with the national database of COVID-19 cases (SIVEP-GRIPE) and the national database of COVID-19 deaths (SIM), from January 27 2020 onwards. We will investigate the association between BCG vaccination status and COVID-19 cases and deaths.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Federal University of Bahia (UFBA) (Brazil)
When is the study starting and how long is it expected to run for?
July 2020 to December 2021
Who is funding the study?
The National Council for Scientific and Technological Development (CNPq) (Brazil)
Who is the main contact?
Dr Susan Martins Pereira, susanmp@gmail.com
Contact information
Scientific
Basílio da Gama St, n/n Campus Universitário Canela
Salvador – BA
40.110-040
Brazil
| Phone | +55 (71) 3283-7373 |
|---|---|
| susanmp@ufba.br |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional cluster randomized trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Effect of BCG vaccination and revaccination on the occurrence and severity of COVID-19 in Brazil |
| Study acronym | REVAC BCG and COVID-19 |
| Study objectives | To estimate and to compare the occurrence and severity of COVID-19 among vaccinated (neonatal BCG vaccination) and revaccinated (neonatal BCG and a second dose of BCG vaccination at school age) during the trial BCGREVAC. |
| Ethics approval(s) | Approved 03/06/2020, Ethics Committee of the Institute of Collective Health (Federal University of Bahia, Basílio da Gama St., n/n – Canela, Salvador-BA, 40.110-040, Brazil; no telephone number provided; cepisc@ufba.br), ref: CAAE: 32820920.7.1001.5030 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) in persons who were previously given the BCG vaccine |
| Intervention | This study looks at patient records from participants in an earlier study who were randomised to receive either vaccination with BCG vaccine produced in Brazil using the Moreaux (Rio de Janeiro) strain, during 1996-1998 or received no vaccination. In each trial arm, vaccination status was evaluated through examination of the BCG scar. This was an open trial, without placebo. Considering that the randomization performed in the past remains after 22 years of follow-up, the individual records from this trial will be linked with two nationwide health datasets: COVID-19 cases notified in the Brazilian Influenza Surveillance System (SIVEP/Gripe) and the COVID-19 deaths registered in the Brazilian Mortality Information System (SIM) databases, from January 27, 2020, onwards. |
| Intervention type | Biological/Vaccine |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bacillus Calmette–Guérin (BCG) vaccine |
| Primary outcome measure(s) |
Measured using patient records at a single timepoint: |
| Key secondary outcome measure(s) |
Mortality from COVID-19 measured using patient records at a single timepoint |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200805 |
| Total final enrolment | 200805 |
| Key inclusion criteria | Participants from the BCGREVAC trial (1996 - 1998) who were diagnosed or died from COVID-19 from January 27, 2020, onwards. |
| Key exclusion criteria | Does not meet inclusion criteria. |
| Date of first enrolment | 01/06/1996 |
| Date of final enrolment | 01/06/1998 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Salvador
40.110-040
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to property rights of the funding agency and ethics reasons related to confidentiality. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/04/2021: Trial's existence confirmed by Ethics Committee of the Institute of Collective Health.
