We have launched the study at RCH but are working hard to get other sites set up in Melbourne and across the country.
If you register your interest here, we will send you updates as more sites are included.
No. You will be randomly allocated to receive or not receive BCG vaccination.
Yes. We need to follow up both the BCG-vaccinated and non-BCG-vaccinated groups, so that we can compare outcomes between the 2 groups.
It is uncertain to what extent BCG given years earlier still has protective off-target effects. You can therefore still take part in the trial.
Yes. There is some evidence that BCG's beneficial off-target effects against infection can be enhanced by a further BCG vaccination in those who have received it in the past.
Yes, but the normal reaction at the injection site may occur earlier and be more pronounced.
Local skin lesions (ulceration and discharge) are more frequent in adults who have had a previous BCG vaccine than those who have never had BCG vaccine before.
However, the risk of severe armpit lymph gland infection or disseminated BCG has not been found to be more common in adults who have had previous BCG vaccine.
No. You are not eligible if you've been treated for TB disease.
Yes. If you have previously had a positive Mantoux tuberculin skin test (TST) or TB blood test (IGRA) but have not required treatment for TB disease then you are eligible for the trial.
The normal reaction at the injection site may occur earlier and be more pronounced.
Local skin lesions (ulceration and discharge) are more frequent in adults who have previously been exposed to TB.
However, the risk of severe armpit lymph gland infection or disseminated BCG has not been found to be more common in adults who have had previous BCG vaccine or previous TB exposure.
Studies suggest that the beneficial off-target effects of BCG vaccination may be evident with days or weeks of vaccination. These effects have been shown to persist up to 12 months in adults.
BCG vaccination through the BRACE trial will be administered with the influenza vaccine provided by your hospital immunisation program.
No, BCG vaccination is a live vaccine and thus it is not recommended in pregnancy. If there is a chance you may be pregnant, discrete pregnancy testing will be made available for any potential participants on the day of vaccination.
Pregnancy should be avoided for 28 days after receiving a live vaccine such as BCG .
1. Kroger AT, Duchin J, Vázquez M. General best practice guidelines for immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html. Accessed on March 22, 2020.