Houston: Researchers in the US’ Texas A&M University are asking hundreds of frontline medical workers to participate in a late-stage, phase 4, clinical trial of a widely-used tuberculosis vaccine that could help boost the immune system and blunt the devastating effects of COVID-19 .
Texas A&M is the first US institution in the clinical trial to have federal clearance for testing on humans. Researchers hope to demonstrate that Bacillus Calmette-Guerin or BCG mitigates the effects of the novel coronavirus, allowing fewer people to be hospitalised or to die from COVID-19.
The researchers are seeking to repurpose the vaccine, which is also used to treat bladder cancer. BCG could be widely available for use against COVID-19 in just six months because it has already been proven safe for other uses, the university said.
“This could make a huge difference in the next two to three years while the development of a specific vaccine is developed for COVID-19,” said Dr Jeffrey D Cirillo, a Regent’s Professor of Microbial Pathogenesis and Immunology at the Texas A&M Health Science Center.
“BCG is not meant to cure coronavirus but bridge the gap until a vaccine is developed, thus allowing us to buy time until something can be developed,” said Dr Cirillo.
Healthcare workers will be the first people eligible for the clinical trial, which is set to begin this week. Efforts are underway to recruit 1,800 volunteers to take part in Texas A&M’s nationwide test of BCG’s application for coronavirus.
“It’s not going to prevent people from getting infected. This vaccine has the very broad ability to strengthen your immune response. We call it ‘trained immunity,” said Dr Cirillo.
Because the human body fights a COVID-19 infection in a manner that is similar to how it would attack bladder cancer, the researchers are hopeful that his work could lead to an effective – and quickly developed – treatment for COVID-19.
Additionally, evidence shows that the coronavirus can cause damage to a patient’s central nervous system, and it even might cause long-term effects that could lead to dementia, Alzheimer’s or Parkinson ‘s disease. Dr Cirillo said the potential for lasting effects from COVID-19 is another reason to get the vaccine to the public as quickly as possible.
Texas A&M University Chancellor John Sharp has offered USD 2.5 million to ensure research can proceed as quickly as possible.
The Texas A&M Health Science Center is leading a group of scientists and medical doctors with 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.
Dr Cirillo said repurposing the existing bladder cancer vaccine called TICE(R) BCG could result in bringing a COVID-19 treatment to the US public in the fastest possible way.
Because the drug is already approved by the FDA, the researchers can skip the first three phases of clinical trials usually required before testing on people, since this vaccine has already passed those phases.
As the coronavirus has spread around the world, researchers have noticed that the morbidity and mortality rates were lower in some developing countries, including India, where the BCG vaccine is widely used.
