Effect of BCG vaccination for tuberculosis on COVID-19 in Brazil

ISRCTN	ISRCTN47802196
DOI	https://doi.org/10.1186/ISRCTN47802196
Secondary identifying numbers	401624/2020-0 (CNPq protocol number)

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Susan Martins Pereira
Scientific

Basílio da Gama St, n/n Campus Universitário Canela
Salvador – BA
40.110-040
Brazil

Phone	+55 (71) 3283-7373
Email	susanmp@ufba.br

Study information

Study design	Interventional cluster randomized trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	School
Study type	Prevention
Participant information sheet	Not applicable (retrospective study)
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Bacillus Calmette–Guérin (BCG) vaccine
Primary outcome measure	Measured using patient records at a single timepoint: 1. COVID-19 incidence 2. COVID-19 severity (COVID-19 severity classification: 1) SpO2 < 95% on room air at sea level; 2) vigorous breathing effort; 3) cyanosis; 4) severe pneumonia; 5) Severe Acute Respiratory Syndrome (SARS); 6) sepsis; 7) septic shock)
Secondary outcome measures	Mortality from COVID-19 measured using patient records at a single timepoint
Overall study start date	10/07/2020
Completion date	31/12/2021

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	200,805
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

Federal University of Bahia (UFBA)

Institute of Collective Health (ISC)
Salvador
40.110-040
Brazil

Sponsor information

National Council for Scientific and Technological Development
Government

SHIS QI 01
Conj. B, Blocos A, B, C e D
Edifício Santos Dumont
Lago Sul
Brasília
71.605-001
Brazil

Phone	+55 (61) 3211-4000
Email	cobio@cnpq.br
Website	http://www.cnpq.br/
"ROR"	https://ror.org/03swz6y49

Funders

Funder type

Government

National Council for Scientific and Technological Development (CNPq)

No information available

Results and Publications

Intention to publish date	01/12/2022
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
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.

Editorial Notes

12/04/2021: Trial's existence confirmed by Ethics Committee of the Institute of Collective Health.