Texas A&M College of Medicine is leading a consortium of research hospitals and medical schools in a Phase 4 trial to determine if the century-old tuberculosis vaccine can help blunt the damage from COVID-19, at least until a vaccine for the new coronavirus has been proven safe and effective.
"Scientists have known for decades that the tuberculosis vaccine, called bacille Calmette-Guerin, or BCG, improves immunity against some viruses," The Texas Tribune reported back in May, when the trial was just getting started. Jeffrey Cirillo, the Texas A&M microbial pathogenesis and immunology professor who is leading the trial, told Politico on Thursday that about 100 people have already been vaccinated, 200-300 more will get their shots over the next two weeks, and the goal is 1,800 subjects in the "randomized, blinded, placebo-controlled trial."
The TB vaccine has been used more than a billion times around the world, but it's not commonly used in the U.S., except to fight bladder cancer. The researchers at Texas A&M, Baylor College of Medicine, Harvard's School of Public Health, Cedars Sinai Medical Center, and the University of Texas MD Anderson Cancer Center are hoping the vaccine ramps up the immune system to fight off the disease, as it does the cancer cells. A similar trial is being conducted in the Netherlands.
The U.S. researchers will monitor the volunteers for six months, looking for statistically significant differences between those who get the BCG vaccine and the group that gets a placebo shot. "We're also doing a cognitive study in parallel to evaluate the cognitive effects of COVID-19," Cirillo told Politico's Myah Ward, using before-and-after MRIs and cognitive assessments to see if the vaccine reduces COVID-19's mental impairments. The vaccine is most effective in the first two to three years, he added, and if it is found to be effective, it could be used either as a stop-gap measure until a coronavirus vaccine arrives or in tandem with that vaccine to make it more effective.