Phase 4 Study Launches in Texas To Prevent Coronavirus Disease

Texas universities announced they are asking 1,800 frontline medical workers to participate in a phase 4 clinical trial of an old tuberculosis vaccine to determine its ability to protect people from the SARS-CoV-2 coronavirus.

With a grant of $2.5 million, Texas A&M is the lead entity in a world-class group of institutions seeking to repurpose the BCG vaccine to prevent COVID-19 disease.

This study includes the Harvard’s School of Public Health, Cedars Sinai Medical Center in Los Angeles, the University of Texas MD Anderson Cancer Center in Houston, and the Baylor College of Medicine in Houston, Texas.

Since there are no U.S. Food and Drug Administration (FDA) approved vaccines, this late-stage, innovative study may be the answer health officials seek. BCG could be widely available for use in the USA in just 6-months because it has already been proven safe.

Globally, the BCG vaccine is administered to children to help prevent tuberculosis and other diseases and on a limited basis, is used to treat bladder cancer patients in the USA.

“It’s not going to prevent people from getting infected,” said Dr. Jeffrey D. Cirillo, a Regent’s Professor of Microbial Pathogenesis and Immunology at the Texas A&M Health Science Center, in a video message.

“However, this (BCG) could make a huge difference in the next two to three years while the development of a specific vaccine is developed for COVID-19.”

Texas A&M Chancellor John Sharp last week offered $2.5 million to make sure the work of Dr. Cirillo can move forward as quickly as possible.

“If there was ever a time to invest in medical research, it is now,” Chancellor Sharp said. 

“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.”

Texas A&M is the first U.S. institution in the clinical trial to have federal clearance for testing on humans. Healthcare workers will be the first people eligible for the clinical trial, which is set to begin in late April 2020.

Recruitment of 1,800 volunteers to participate in the trial is already underway in College Station and Houston, Texas.

As the coronavirus spreads, researchers noticed that the morbidity and mortality rates were lower in some developing countries where the BCG vaccine is widely used.

The Texas A&M University System is one of the largest systems of higher education in the nation with a statewide network of 11 universities that educates more than 151,000 students.

SARS-CoV-2 coronavirus vaccine development news published by PrecisionVaccinations.