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Bacillus Calmette-Guérin (BCG) Study to Help Prevent COVID-19

SARS-CoV-2 (COVID-19) is a contagious virus affecting everyone at this time. There is no current vaccination or treatment against this virus. Researchers at Texas A&M University, in collaboration with MD Anderson Cancer Center, Baylor College Medicine and Cedars Sinai Medical Center, are looking for health care worker and first responder volunteers to participate in a study evaluating Bacillus Calmette Guérin (BCG) vaccine as a booster of the immune response and to study if this vaccine reduces illness severity from coronavirus.

The goal of this trial is to learn if a Bacillus Calmette-Guérin (BCG) vaccination, a nearly 100-year-old commonly used tuberculosis (TB) vaccine, can help prevent COVID -19 infection and/or mitigate the severity of the illness compared to a placebo.

Vaccine Trial Eligibility and Consent

To participate, volunteers must be:

  • Between the ages of 18 and 75
  • Personnel working at a hospital, medical center or clinic, including medical, veterinary, dental and ophthalmology; or first responders such as law enforcement, firefighters or paramedics
  • Able to use their own device to provide data electronically (e.g. via smartphone or tablet)
  • Able to participate for six months

If you would like to participate, consent will be collected electronically and by phone in adherence with current physical distancing practices. Volunteers receive a one-time vaccination and will submit daily diary entries on an electronic device (e.g. smart phone or tablet) through a secure research "app" or web portal. Optionally, blood samples and stool samples will be collected at designated timepoints.

TO SEE IF YOU ARE ELIGIBLE, TAKE THE SCREENING SURVEY

FREQUENTLY ASKED QUESTIONS

Yes, the BCG vaccine has been used for nearly 100 years across the world. As with every vaccine, side-effects may occur. The most common side effects include scarring at the injection site over time and redness at the injection site for a few months after vaccination.
The BCG trial is a late-stage, phase 4 clinical trial of a commonly used tuberculosis vaccine. The trial is repurposing an already FDA-approved vaccine, which means that it could be widely used more rapidly than a new vaccine.
Volunteers will be required to provide weekly health reports and monthly blood tests.
Due to the close proximity with patients and the public, health care workers and first responders have a greater risk of contracting COVID-19.
Volunteers are asked to participate for a minimum of six months.
BGC vaccine may cause a positive to the skin test, but the TB blood test is not affected by the vaccination and should be used to monitor TB exposure in the future.
If you have a family member or friend that might meet the trial criteria, please direct them to our website health.tamu.edu/bcgtrial for information and to sign up.
IRB Number 2020-0432F IRB Approval Date: 8/25/2020