Texas A&M University researchers are searching for local medical professionals to participate in a clinical trial of a common tuberculosis vaccine that may be able to treat COVID-19.
Lead researcher in the US Jeffrey Cirillo said fewer than 100 people — the minimum number needed to start vaccinations — are signed up locally as of Tuesday. The regent’s professor of microbial pathogenesis and immunology at the Texas A&M Health Science Center said he’s aiming to begin administering vaccines at the end of this week or early next week.
The vaccine — which is called BCG and is also used to treat bladder cancer in the US — could potentially be available to treat COVID-19 in six months since it is widely used and has FDA approval so it does not need to go through the first three phases of a clinical trial like new vaccines. BCG is starting in a late stage, phase four clinical trial, while Cirillo said others that are being developed could take years to get through the first three phases, which are meant to identify the effects of the vaccine.
“It’s still very early,” Cirillo said, “but this is the only vaccine in the world that could be used basically immediately, if we obtain good data from this trial.”
Cirillo and the Texas A&M Health Science Center are leading a group of scientists and 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 the Baylor College of Medicine in Houston in the effort, according to an A&M System press release. Cirillo said there are clinical trials for how BCG can fight COVID-19 being conducted around the world, including in Australia, the Netherlands and Germany.
BCG isn’t expected to prevent people from contracting COVID-19, Cirillo said, but researchers believe it may mitigate the effects of the virus so fewer people are hospitalized or die from it. Cirillo said BCG allows a person’s immune response to kill nearly any type of infection, meaning it essentially broadly strengthens people’s immune response.
While there will still be hospitalized COVID-19 patients, Cirillo said BCG could help reduce the number of people who need to be in the ICU. Additionally, he said researchers are hoping to lower the US’ current death rate of about 6% down to 1% by implementing the vaccine.
Many long-term effects of COVID-19 remain unknown, but Cirillo said research suggests that people who had coronavirus could be predisposed to chronic obstructive pulmonary disease, Alzheimer’s disease or other conditions. Since BCG has been proven to reduce the frequency of Alzheimer’s disease and cognitive impairment later in life, Cirillo said the vaccine may also help mitigate problems that COVID-19 might cause years down the road.
BCG was developed in the 1920s, and Cirillo said it has been known for years that it is effective in fighting many infectious diseases. He said it is particularly effective against viral infections that are similar to COVID-19, in that they cause inflammatory responses.
“Complications from this vaccine are extremely low — exceptionally low,” Cirillo said.
Researchers have already found that the number of cases, the morbidity and mortality rates associated with COVID-19 are lower in countries where the BCG vaccine is widely used.
Last week, A&M System Chancellor John Sharp gave the US researchers $2.5 million to work on the project. Prior to this, Cirillo said he was writing five to 10 grant applications per day trying to earn enough funding to get started.
The clinical trial will include 1,800 participants, with up to 700 of those being from Texas A&M and affiliate locations. Depending on the level of interest in different areas, Cirillo said that up to 700 people from the Bryan-College Station area could participate throughout the process.
Researchers, Cirillo said, will closely monitor many factors including symptoms exhibited by people in the study and their immune response.
Cirillo said he has worked with this vaccine for more than three decades, and while this new initiative can be taxing, he said it is incredibly important.
“As a scientist the most important thing, at least for me, is being able to have an impact on people’s lives, and see something we’ve been working on get to patients,” Cirillo said. “It’s probably the most rewarding thing I’ve done. I’m just really happy to be able to do it.”