BCG Vaccination to Protect Healthcare Workers Against COVID-19

• Status: Active, not recruiting
• Trial end date: 2022-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Murdoch Childrens Research Institute
• Collaborators: Bill and Melinda Gates Foundation; Royal Children's Hospital
• Treatments: BCG Vaccine; Vaccines

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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