Researchers have noted an interesting possible association: as the COVID-19 spread the morbidity and mortality rates appeared to be lower in some developing countries where the BCG vaccine is widely used. Texas A&M investigators are recruiting hundreds of frontline medical workers to participate in a late-stage, Phase 4, clinical trial of a widely used vaccine that could blunt the devastating effects of COVID-19. Chancellor John Sharp offered $2.5 million to help the study. The Aggie researchers are the first U.S. institution in the clinical trial to have federal clearance for testing on humans.
Chancellor Sharp’s $2.5m Makes a Difference
TrialSite News has introduced multiple initiatives worldwide investigating any associations between the BCG vaccine and reductions in COVID-19 related death rates.
Texas A&M recently reported that the university was the lead entity in a world-class group of clinical investigational sites seeking to repurpose the BCG vaccine, which also happens to be used to treat bladder cancer in America.
Chancellor Sharp’s $2.5 million contribution helps to ensure the work of Dr. Jeffrey D. Cirillo can move forward in an expeditious manner. Noting the importance of Cirillo and teams’ work, Chancellor Sharp commented, “If there was ever a time to invest in medical research, it is now.” The Chancellor continued “Dr. Cirillo has a head start on a possible coronavirus treatment, and I want to make sure he has what he needs to protect the world from more of the horrible effects of this pandemic.” What is the impact—huge. For example, now Cirillo and team can focus on the important research at hand a not have to continuously worry about funding and the associated continuous grant writing effort which of course is a time drain.
What is the BCG Vaccine?
The Bacillus Calmette-Guerin (BCG) vaccine is a vaccine primarily used against tuberculosis (TB). In countries where TB or leprosy is common, one dose is recommended in healthy babies as close to the time of birth as possible. In areas where TB isn’t common, only children at high risk are typically immunized. Suspected cases of TB are often individually tested for and treated. BCG has also some effectiveness against Buruli ulcer infection and other nontuberculous mycobacteria infections. It is also used as part of the treatment of bladder cancer.
This study is sponsored by Texas A&M Health Science Center in collaboration with a group of scientists and medical doctors from Harvard’s School of Public Health, the University of Texas MD Anderson Cancer Center in Houston, Cedars Sinai Medical Center in Los Angeles and Baylor College of Medicine in Houston are hoping to demonstrate that the BCG mitigates the effects of the virus, allowing fewer people to be hospitalized or to die from COVID-19.
The participating research sites have commenced recruitment efforts—they need 1,800 participants for this trial already underway in College Station and Houston. The study will expand to other areas of the state and out of Texas in Los Angeles, CA and Boston, MA.
The sponsor has established the primary outcome measure as the incidence of COVID-19 infection—looking at a time frame of 6 months. The investigators will use the COX proportional-hazards model to calculate hazard rations for the development of COVID-19. This will be reported as the proportion of individuals receiving the intervention who are PCR-positive or seroconvert: defined as a number of new cases during the 6-month time period.
Not a Vaccine
One of the study leads highlighted previously by TrialSite News, Dr. Jeffrey D. Cirillo, commented that this treatment won’t stop people from getting infected from COVID-19 but rather the “vaccine has the very broad ability to strengthen your immune response. We call it ‘trained immunity.’”
By repurposing the bladder cancer vaccine called TICE®BCG, Cirillo declared, perhaps there is a way to fast track a COVID-19 treatment to the U.S. public. After all, the drug is already approved by the U.S. Food and Drug Administration (FDA). Hence if the study shows efficacy (and is safe) they can potentially skip the first three phases of clinical trials typically required prior to testing on people. But this vaccine has already been tested in those phases. Information about the product at the FDA’s website is here.
Dr. Jeffrey D. Cirillo, PhD, Regents’ Professor, Department of Microbial Pathogenesis and Immunology; Director of the Center for Airborne Pathogen Research and Imaging (CAPRI)
There are several investigators involved in this study from Texas A&M as well as the other institutions mentioned.