Status:
COMPLETED
BCG Vaccination to Protect Healthcare Workers Against COVID-19
Lead Sponsor:
Murdoch Childrens Research Institute
Collaborating Sponsors:
Royal Children's Hospital
Bill and Melinda Gates Foundation
Conditions:
Coronavirus Disease 2019 (COVID-19)
Respiratory Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Phase III, two-group multicentre, randomised controlled trial in up to 10 078 healthcare workers to determine if BCG vaccination reduces the incidence and severity of COVID-19 during the 2020 pandemic...
Detailed Description
Healthcare workers are at the frontline of the coronavirus disease (COVID-19) pandemic. They will be randomised to receive a single dose of BCG vaccine or 0.9% NaCl placebo. Participants will be follo...
Eligibility Criteria
Inclusion
- Over 18 years of age
- Healthcare worker
- This is defined as anyone who works in a healthcare setting or has face to face contact with patients.
- Provide a signed and dated informed consent form
- Australian sites only: If annual influenza vaccination is available, receiving the flu vaccine is an eligibility requirement. The flu vaccine will be required a minimum of 3 days in advance of randomisation in the BRACE trial.
- Pre-randomisation blood collected
Exclusion
- Has any BCG vaccine contraindication
- Fever or generalised skin infection (where feasible, randomisation can be delayed until cleared)
- Weakened resistance toward infections due to a disease in/of the immune system
- Receiving medical treatment that affects the immune response or other immunosuppressive therapy in the last year.
- These therapies include systemic corticosteroids (≥20 mg for ≥2 weeks), non-biological immunosuppressant (also known as 'DMARDS'), biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha).
- People with congenital cellular immunodeficiencies, including specific deficiencies of the interferon-gamma pathway
- People with malignancies involving bone marrow or lymphoid systems
- People with any serious underlying illness (such as malignancy)
- NB: People with cardiovascular disease, hypertension, diabetes, and/or chronic respiratory disease are eligible if not immunocompromised, and if they meet other eligibility criteria
- Known or suspected HIV infection,even if they are asymptomatic or have normal immune function.
- This is because of the risk of disseminated BCG infection
- People with active skin disease such as eczema, dermatitis or psoriasis at or near the site of vaccination
- A different adjacent site on the upper arm can be chosen if necessary
- Pregnant
- Although there is no evidence that BCG vaccination is harmful during pregnancy, it is a contra-indication to BCG vaccination. Therefore, we will exclude women who think they could be pregnant or are planning to become pregnant within the next month.
- UK specific: Although there is no evidence that BCG vaccination is harmful during pregnancy, it is a contra-indication to BCG vaccination. Therefore, we will exclude women of childbearing potential (WOCBP) who think they could be pregnant.
- Spain specific: If the patient is female, and of childbearing potential, she must have a negative pregnancy test at the time of inclusion and practice a reliable method of birth control for 30 days after receiving the BCG vaccination.
- Another live vaccine administered in the month prior to randomisation
- Require another live vaccine to be administered within the month following BCG randomisation
- If the other live vaccine can be given on the same day, this exclusion criteria does not apply
- Known anaphylactic reaction to any of the ingredients present in the BCG vaccine
- Previous active TB disease
- Currently receiving long term (more than 1 month) treatment with isoniazid, rifampicin or quinolone as these antibiotics have activity against Mycobacterium bovis
- Previous adverse reaction to BCG vaccine (significant local reaction (abscess) or suppurative lymphadenitis)
- BCG vaccine given within the last year
- Have previously had a SARS-CoV-2 positive test result (positive PCR on a respiratory sample or a positive SARS-CoV-2 diagnostic antigen test approved by the local jurisdiction's public health policy)
- Already part of this trial, recruited at a different site/hospital.
- Participation in another COVID-19 prevention trial
- Have previously received a COVID-19-specific vaccine
Key Trial Info
Start Date :
March 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2022
Estimated Enrollment :
6828 Patients enrolled
Trial Details
Trial ID
NCT04327206
Start Date
March 30 2020
End Date
May 27 2022
Last Update
September 19 2024
Active Locations (36)
Enter a location and click search to find clinical trials sorted by distance.
1
St Vincent's Hospital, Sydney
Sydney, New South Wales, Australia, 2010
2
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
3
Sydney Children's Hospital, Randwick
Sydney, New South Wales, Australia, 2145
4
The Children's Hospital at Westmead
Sydney, New South Wales, Australia, 2145