Overview

As well as preventing severe tuberculosis (TB) in children, the BCG vaccine has off-target (non-specific or immunomodulatory) effects which may enhance protection against other infections. That’s why this multi-centre, randomised controlled clinical trial is working to determine:

• Whether BCG vaccine reduces the incidence of symptomatic and severe COVID-19
• If BCG vaccine reduces the impact of other respiratory illnesses and allergic diseases
• The immunological mechanisms that underlie BCG’s off-target effects, COVID-19 severity and risks
• The safety profile of BCG vaccination and revaccination in adults
• If BCG alters the acquisition of latent TB in healthcare workers
• Biomarkers predictive of COVID-19 risk, severity and vaccine efficacy 

Trial data

So far, the trial has generated:

A cutting-edge study of BCG vaccines off-target effects 

Contact us

The BRACE trial
Murdoch Children's Research Institute
The Royal Children's Hospital
50 Flemington Road
Parkville VIC 3052
Australia

Email:  show email address

Information for participants

Thank you BRACE trial participants!

It's been three years since the BRACE trial began and investigators from Australia, the Netherlands, Spain, the UK and Brazil thank the almost 7,000 healthcare workers who signed up for taking part.

Your involvement has been an important contribution to the work to determine whether BCG’s ability to change immune responses reduces the severity of COVID-19 as well as other infectious and allergic diseases.

Every survey, blood sample, COVID-19 test and app or phone check-in mattered in this global effort to understand the potential benefits of BCG vaccine during the COVID-19 pandemic.

The trial’s primary outcomes were published in April 2023.

What participants need to know

Research team

Over 400 researchers and staff across five countries are involved in the BRACE BCG vaccine trial study team. 

Professor Nigel Curtis, BRACE trial Chief Principal Investigator

Paediatric infectious diseases physician and clinician scientist. Professor Nigel Curtis is the leader of the Infectious Diseases Research Group at Murdoch Children's Research Institute, Professor of Paediatric Infectious Diseases at the University of Melbourne and Head of Infectious Diseases at The Royal Children's Hospital Melbourne.

The BRACE trial is a randomised controlled clinical trial working to determine if BCG vaccination reduces the impact of COVID-19 and other diseases in healthcare workers.

Since launching in March 2020, the trial has recruited over 6,800 participants in five countries.

Find an expert

Want to join the BRACE trial study team?

International Principal Investigators from 36 sites

A global effort to study BCG off-target effects

• The Royal Children's Hospital (Melbourne)
• The University of Melbourne
• Telethon Kids Institute (TKI)
• South Australian Health & Medical Research Institute (SAHMRI)
• National Centre for Immunisation Research and Surveillance
• University Medical Center (UMC) Utrecht
• The University of Exeter
• Universidade Federal de Mato Grosso do Sul (UFMS)
• Fundação Oswaldo Cruz (Fiocruz)
• Tropical Medicine Foundation Doctor Heitor Vieira Dourado (FMT-HVD)

The BRACE trial – one year on

Professor Curtis, international Principal Investigators, Ann Ginsberg of the Bill & Melinda Gates Foundation and the global study team celebrate one year since the trial began.

Feature videos

BRACE marks Clinical Trials Day 2021

Hear from Ann Ginsberg, of the Bill & Melinda Gates Foundation, about how the BRACE trial has risen to the challenge of running the largest BCG vaccine study for healthcare workers during the global pandemic.

Watch video on YouTube

BRACE in Brazil

Hear from our Brazilian investigators Professor Julio Croda and Professor Margareth Dalcolmo about how the multinational BCG vaccine study is going, and what will happen next.

Watch video on YouTube

Go behind the scenes

Take a peek inside the world’s largest trial on the off-target effects of BCG vaccine. See inside our clinics and laboratories across five countries as the study team prepares for the six-month primary outcomes.

Watch video on YouTube

Women and Girls in Science

Dr Nicole Messina, BRACE Biosample and Laboratory Lead, met budding young Melbourne scientist Maddie, 6-years-old, for International Day of Women and Girls in Science on 11th February 2022.

Watch video on YouTube

Stay up-to-date with the latest news, BCG vaccine research, videos and results from across the trial

Who is enrolled in the BRACE trial across our 36 sites?

• Australia 50%
• Europe 15%
• Brazil 35%

Trial updates

BRACE biosample and laboratory lead, Dr Nicole Messina, receives NHMRC Ideas Grant.

November 2021

Read more about grants

Our BCG vaccine trial joins global race to better understand COVID-19 variants.

June 2021

Read more about the BCG Trial

Could BCG vaccine protect against COVID-19? UK recruitment begins.

October 2020

Read more about the BCG vaccine

$10M grant enables MCRI’s BCG vaccine trial to expand internationally

May 2020

Read more about the $10M grant

Murdoch Children's to trial preventative vaccine for COVID-19 healthcare workers

March 2020

Read more about the trial

Brace trial timeline

This graphic shows the timeline of the BRACE trial.

Read the latest global media coverage

BRACE trial videos

See more BRACE videos on YouTube.

Injection of Hope: The hunt for a COVID-19 vaccine

Four Corners, ABC Australia

Could a century-old tuberculosis vaccine help fight COVID-19?

Bloomberg Quicktake - Twitter 

For more any media enquiries please contact us below:

Collaborators

• The Royal Children's Hospital (Melbourne)
• The University of Melbourne
• Telethon Kids Institute (TKI)
• South Australian Health & Medical Research Institute (SAHMRI)
• National Centre for Immunisation Research and Surveillance
• University Medical Center Utrecht (UMC) Utrecht
• The University of Exeter
• Universidade Federal de Mato Grosso do Sul (UFMS)
• Fundação Oswaldo Cruz (Fiocruz)
• Tropical Medicine Foundation Doctor Heitor Vieira Dourado (FMT-HVD)

With the support of visionary philanthropists, the BRACE trial has become the largest study of its kind worldwide. 

Our donors

A special thank you to our generous donors.

• Bill & Melinda Gates Foundation
• Minderoo Foundation
• The Royal Children's Hospital Foundation
• Sarah and Lachlan Murdoch
• Health Services Union NSW
• Peter Sowerby Foundation
• SA Health
• The Insurance Advisernet Foundation
• NAB Foundation
• The Calvert Jones Foundation
• Modara Pines Charitable Foundation
• UHG Foundation Pty Ltd
• Epworth HealthCare
• Individual donors

The face of BRACE

BRACE is a randomised controlled trial that includes over 6,800 healthcare workers recruited in 36 sites across five countries to assess whether the off-target effects of Bacille Calmette-Guérin (BCG) vaccination reduce the incidence of symptomatic and severe COVID-19. The study is also investigating whether BCG vaccine reduces the impact of other illnesses, such as respiratory illnesses and allergic diseases.

In April 2021, the trial introduced the BRACE COVID-19-Specific vaccine sub-study (BCOS) to explore whether it’s possible to predict who remains susceptible to SARS-CoV-2 variants despite previous COVID-19 infection or COVID-19-specific vaccination. The sub-study will look at whether BCG vaccine improves the immune response to Pfizer, AstraZeneca and CoronaVac vaccines.

So far, the international study team of over 400 researchers and staff have collected more than a quarter of a million samples, attracted a global media audience of over five billion people and secured $15 million-plus in philanthropic funding – and all this with a 100-year-old vaccine.

Learn about BCG vaccine research

The BCG vaccine has been studied for several years to better understand its off-target effects. Some notable BCG research papers include:

BRACE Protocol & SAP

• BCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial). BMJ Open, 2021
• BRACE trial SAP

BRACE Primary Outcomes

• Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers. The New England Journal of Medicine, 2023
• BCG to Protect against Covid-19 in Health Care Workers. The New England Journal of Medicine, 2023

BRACE Exploratory Outcomes

• Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trial. eClinicalMedicine, 2023

BRACE Immunology Studies

• Off-target effects of bacillus Calmette–Guérin vaccination on immune responses to SARS-CoV-2: implications for protection against severe COVID-19. Clinical & Translational Immunology, 2022

BRACE Safety

• Safety of BCG vaccination and revaccination in healthcare workers. Human Vaccine Immunotherapeutics, 2023
• Factors influencing scar formation following Bacille Calmette-Guerin (BCG) vaccination. Heliyon, 2023
• Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathy. NPJ Vaccines, 2022
• The safety of BCG revaccination: A systematic review. Vaccine. 2021

Reviews

• Interpreting the results of trials of BCG vaccination for protection against COVID-19. The Journal of Infectious Diseases, 2023
• Bacille Calmette Guérin (BCG) and new TB vaccines: Specific, cross-mycobacterial and off-target effects. Paediatric Respiratory Reviews, 2020
• The influence of BCG on vaccine responses – a systematic review. Expert Review of Vaccines, 2018

Other

• Impact of vaccine platform and BCG vaccination on antibody responses to COVID-19 vaccination. Frontiers in Immunology, 2023
• Considering BCG vaccination to reduce the impact of COVID-19. The Lancet, 2020
• Bacille Calmette-Guérin (BCG) vaccination and COVID-19. World Health Organization (WHO), 2020