BCG Vaccination to Protect Healthcare Workers Against COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

6828 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2022-05-27

Brief Summary

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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.

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Detailed Description

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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 followed-up for 12 months with notification from a Smartphone application or phone calls (up to daily when ill) and surveys to identify and detail COVID-19 infection. Additional information on severe disease will be obtained from hospital medical records and/or government databases. Blood samples will be collected prior to randomisation and at 3, 6, 9 and 12 months to determine exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Where required, swab/blood samples will be taken at illness episodes to assess SARS-CoV-2 infection.

The trial includes a pre-planned meta-analysis with data from 2834 participants recruited in the Stage 1 of this study, where participants were randomised to receive BCG or no BCG vaccine at the time of receiving influenza vaccination.

Conditions

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Coronavirus Disease 2019 (COVID-19) Respiratory Illness Corona Virus Infection COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase III, two group, multicentre, randomised controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The control group will receive a placebo of 0.9% sodium chloride (NaCl). Members of the research team doing the follow-up of participants and analysis will be blinded to the group allocation (by the removal of this variable and all other variables related to BCG from the dataset) until the formal detailed statistical analysis plan is confirmed and signed by all investigators and all data cleaning/preparation is complete.

Study Groups

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BCG vaccine

Participants will receive a single dose of BCG vaccine (BCG-Denmark). The adult dose of BCG vaccine is 0.1 mL injected intradermally over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the upper arm).

Group Type EXPERIMENTAL

BCG Vaccine

Intervention Type DRUG

Freeze-dried powder: Live attenuated strain of Mycobacterium bovis (BCG), Danish strain 1331.

Each 0.1 ml vaccine contains between 200000 to 800000 colony forming units. Adult dose is 0.1 ml given by intradermal injection

0.9% Saline

Participants will receive a single 0.1 mL dose of 0.9%NaCl injected intradermally over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the upper arm).

Group Type PLACEBO_COMPARATOR

0.9%NaCl

Intervention Type DRUG

0.9% Sodium Chloride Injection

Interventions

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BCG Vaccine

Freeze-dried powder: Live attenuated strain of Mycobacterium bovis (BCG), Danish strain 1331.

Each 0.1 ml vaccine contains between 200000 to 800000 colony forming units. Adult dose is 0.1 ml given by intradermal injection

Intervention Type DRUG

0.9%NaCl

0.9% Sodium Chloride Injection

Intervention Type DRUG

Other Intervention Names

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Bacille Calmette-Guerin Vaccine Bacillus Calmette-Guerin Vaccine Statens Serum Institute BCG vaccine Mycobacterium bovis BCG (Bacille Calmette Guérin), Danish Strain 1331 BCG Denmark 0.9% Saline

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof Nigel Curtis

Role: PRINCIPAL_INVESTIGATOR

Murdoch Childrens Research Institute

Locations

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