BCG vaccination to reduce the impact of COVID-19 in healthcare professionals after Coronavirus exposure
Healthcare professionals and others who come into contact with COVID-19 patients have an increased risk of infection with COVID-19. There is currently no vaccine or proven preventive 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. The Bacillus Calmette-Guérin (BCG) vaccine is designed to protect against tuberculosis (TB), but this vaccine may also provide wider protection against other infections. In the BRACE study, 10,000 healthcare professionals are enrolled in Europe and Australia to investigate whether this broader protection also helps with a COVID-19 infection.
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.
What to expect
- 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.
- 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
- 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:
- 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
- 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.
- 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
- 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
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. If you are not working at a participating hospital and still want to participate in this trial, you can register at the location nearest to you.
Before registering with a hospital, we ask you to read the Patient Information carefully and go through a checklist so that you can test your eligibility for participation. You can also download the Patient Information.
|Radboudumc, Nijmegen||BRACEstudie.email@example.com||website Radboudumc|
(alleen voor medewerkers Rijnstate)
|Amphia, Breda||BRACE@amphia.nl||076-59 52 061|
|Noordwest Ziekenhuis, Alkmaarfirstname.lastname@example.org||072-54 84 142|
|St. Antonius, Nieuwegein||Bracestudie@antoniusziekenhuis.nl|
|UMCUtrecht, Utrechtemail@example.com||06-501 77 450|
Frequently Asked Questions
Can I choose whether I receive the BCG vaccination or the placebo or not?
No. It is randomly determined whether you receive the BCG vaccine or the placebo vaccine.
What is a placebo?
A placebo is similar to a real treatment but does not contain any active ingredients. In this study, the placebo is an injection that looks exactly like the BCG vaccine but is not a vaccine.
Why is a placebo used?
Sometimes people respond to a treatment, regardless of what that treatment is. This is called the placebo effect. It is caused by the person's belief in the benefit of the treatment and the expectation that he is feeling better, rather than the treatment itself. Using a placebo means that the results of the study are not affected by people who know they have received BCG or placebo.
I have had a BCG vaccination before. Can I still participate in the study?
Yes. There is some evidence that BCG's beneficial off-target effect may be enhanced by a new BCG vaccination in people who have received the vaccine in the past.
I have had a BCG vaccination before. Is it safe to get another one?
Yes, but the normal injection site reaction may occur earlier and be more severe.
Local skin lesions (ulceration and discharge) are more common in adults who have previously had the BCG vaccine than in people who have not previously had the BCG vaccine.
The risk of serious armpit lymph node infection or systemic BCG infection is no higher in adults who have previously had a BCG vaccine.
Can I get the BCG vaccine if I have had active tuberculosis (TB)?
No. You cannot participate in this study if you have been treated for tuberculosis.
Is it safe to get the BCG vaccine if I have been exposed to tuberculosis (TB) but did not need treatment?
Yes. If you have previously had a positive Mantoux tuberculin skin test (TST) or TB blood test (IGRA), but do not need (have had) treatment for TB disease, you are eligible to participate in the study.
Is it safe to get the BCG vaccination if there are people in my house who have a lowered immune system?
How fast does BCG vaccination work?
Research indicates that the beneficial off-target effects of BCG vaccination start within a few days to weeks after vaccination. These effects last up to 12 months after vaccination in adults.
I received the BCG vaccine as a child. Am I protected against COVID-19?
It is currently unknown whether the “off-target” effects of a BCG vaccine given many years earlier remain protective. The best way to protect yourself against the covid-19 infection is to wash your hands regularly and thoroughly, keep a distance of 1.5 meters and, for healthcare personnel, use personal protective equipment (PPE). The World Health Organization (WHO) has emphasized that the non-peer-reviewed pre-print studies suggesting that BCG vaccination in children is protective can be misleading: Such studies are susceptible to significant bias in results, including differences in demographics and disease burden, test rates for COVID-19 and the stage of the pandemic in each country.
3584 CX Utrecht