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BRACE

What Is BRACE?

Researchers Marc Bonten And Mihai Netea About The BRACE Trial

Healthcare professionals and others in close contact with COVID-19 patients, have an increased risk of infection with COVID-19, which is caused by the SARS-CoV-2 virus. There is currently no vaccine or proven preventative treatment available for COVID-19, so protection against infection depends purely on the use of personal protective equipment such as mouth masks to protect healthcare workers. If employees become ill in large numbers and cannot work, the healthcare system will come under greater pressure.

The Bacillus Calmette-Guérin (BCG) vaccine is designed to protect against tuberculosis (TB), but this vaccine may also provide wider protection against other infections. The results of this study may indicate whether BCG vaccination could be used as an early intervention to protect healthcare professionals and other risk groups in future viral outbreaks.

In the BRACE study, 10,000 healthcare professionals are enrolled in Europe and Australia. The institution / hospital where you work will not be informed of your participation in this study. There are no costs for participation and there is no reimbursement for participation. All medications, tests, and medical care needed as part of the study are provided free of charge.

This project is a collaboration between Murdoch Children's Research Institute in Melbourne Australia, Radboud University Nijmegen, and University Medical Centre Utrecht.

You can no longer register to participate in this study

What To Expect

Why participate:

  • We hope that the BCG vaccine will strengthen your immune system. BCG may offer wider, “non-specific” protection against other infections.
  • Information we collect in this study will help us to best respond to outbreaks of new viruses in the future.
  • We cannot guarantee or promise that you will receive any benefit from participating in this study.

 What does participation mean:

  • a blood sample (2 tubes) at the start of the study, and after 3 and 12 months
  • random assignment to the study arm: BCG vaccine group or placebo group
  • download a smartphone app to report respiratory complaints and fever every week
  • Have a SARS-CoV-2 test done if you have suspicious symptoms
  • complete online surveys after 3, 6, 9, and 12 months

Potential risks for participants:

  • Sometimes people experience adverse effects from the BCG vaccine. Most of these involve small and local reactions around the injection site. This is described in the detailed information you will receive before deciding whether to participate in the study.
  • Taking blood may cause discomfort or bruise. Taking a throat swab can be uncomfortable. Trained medical personnel from the study team will collect these samples.

Do I meet the participation criteria?

You are eligible if you meet the following inclusion and exclusion criteria:
 
Inclusion criteria:

  • You are 18 or older
  • You work in a healthcare setting OR have face-to-face contact with patients
  • A signed informed consent
  • Blood collection before randomization

Exclusion criteria:

  • Contraindication for BCG vaccination. This includes:
  • Fever or generalized skin infection
  • Weakened resistance to infections due to disease of the immune system
  • Undergo medical treatment affecting the immune response or other immunosuppressive therapy in the past year.

• These therapies include. systemic corticosteroids (≥ 20 mg for ≥ 2 weeks).

  • People with congenital cellular immunodeficiency, including specific deficiencies of the interferon gamma pathway
  • People with malignancies involving bone marrow or lymphoid systems
  • People with a serious underlying disease (such as malignancy)
  • NB: people with cardiovascular disease, hypertension, diabetes and / or chronic respiratory diseases are eligible
  • Known or suspected HIV infection, even if they are asymptomatic or have normal immune function.
  • People with active skin disease such as eczema, dermatitis or psoriasis at or near the vaccination site
    • If necessary, another location (other than the left arm) can be selected
  • Pregnancy
  • Another live vaccine administered in the month prior to randomization
  • Require another live vaccine to be administered within one month of BCG randomization
  • Known anaphylactic reaction to one of the ingredients in the BCG vaccine
  • Previous active TB disease
  • Previous side effect of BCG vaccine (abscess or suppurative lymphadenitis)
  • BCG vaccine given in the past year
  • Have previously had a SARS-CoV-2 positive test result
  • Is already part of this study through another hospital.
  • Participation in another COVID-19 prevention study

Before the inclusion, all criteria will be discussed with you extensively. You can discuss any questions or doubts at your randomisation visit. You can decide not to participate at any time until the scheduled vaccination.

Participating Hospitals And Registration

UMC Utrecht coordinates a multicentre randomized clinical trial within Europe of the BCG vaccine against COVID-19.
Below you can see which hospitals are participating in the study. 

Participating hospitalsContactPhonennumberWebsite
Radboudumc, Nijmegen
Registration for participation is no longer possible
BRACEstudie.aig@radboudumc.nl  website Radboudumc
Rijnstate, Arnhem
Registration for participation is no longer possible
BRACE@rijnstate.nl  
Amphia, Breda
Registration for participation is no longer possible
BRACE@amphia.nl076-59 52 061 
Noordwest Ziekenhuis, Alkmaar
Registration for participation is no longer possible
researchlongziekten@nwz.nl072-54 84 142 
St. Antonius, Nieuwegein
Registration for participation is no longer possible
Bracestudie@antoniusziekenhuis.nl  
UMCUtrecht, Utrecht
Registration for participation is no longer possible
braceumcu@umcutrecht.nl06-501 77 450 

Contact

UMC Utrecht
Heidelberglaan 100
3584 CX Utrecht
BRACE@umcutrecht.nl