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

SARS-CoV-2 (the virus that causes COVID-19) is a contagious virus affecting everyone. 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 workers, first responders, front line workers, seniors and those with preexisting health conditions to participate in a study evaluating the Bacillus Calmette Guérin (BCG) vaccine as a booster of the immune response and to study if this vaccine reduces illness severity from coronavirus. The study will also examine if BGC will improve efficacy of recent vaccines.

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:

At least 18 years old
Personnel working at a hospital, medical center or clinic, including medical, veterinary, dental and ophthalmology; first responders such as law enforcement, firefighters or paramedics; front line workers such as a teachers, wait staff, grocery store workers; or high risk individuals such as the elderly and those with preexisting health conditions
Able to use their own device to provide data electronically (e.g. via smartphone or tablet)
Able to participate for at least 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 injection and will submit weekly surveys on an electronic device (e.g. smart phone or tablet) through a secure web portal and monthly home fingerstick blood samples will be procured. Optionally, blood samples will be collected at designated timepoints.

The Covid-19 Vaccine Trial Texas A&M Health Is Leading

TO SEE IF YOU ARE ELIGIBLE, TAKE THE SCREENING SURVEY

Brazos Valley/Bell or Williamson County

Dallas

Houston

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.

The other vaccines will not impact the BADAS study. That is because this vaccine, BCG, has been previously shown to improve efficacy of other specific vaccines. Therefore, we expect that participants in our study could display reduced side-effects from other vaccines as well as better and longer-lasting protection as a result of the vaccine. We will be examining this closely over the coming months and hope that many of our subjects will receive the specific vaccines, giving us enough numbers to be able to see differences between the groups.

Yes.

No, it is actually very important for you to continue participating after you have had COVID. Having COVID and seeing the severity of disease that occurred, as well as the immune response, provides the most important data about protection from COVID. Your response, particularly as shown by the blood sample you provide every month, allows us to see how well your body handled the virus and will allow us to determine how well the vaccine worked.

IRB Number 2020-0432F IRB Approval Date:1/20/2021