COVID-19 clinical trial

Texas A&M University researchers vaccinated more than 50 health care workers on Wednesday, May 6, 2020 as they started a clinical trial for a vaccine they believe can mitigate the effects of COVID-19.

Texas A&M University researchers vaccinated more than 50 health care workers on Wednesday as they started a clinical trial for a vaccine they believe can mitigate the effects of COVID-19.

The BCG vaccinations administered at the Bryan Medical Center were the first ones in the U.S. clinical trial, but they were just a handful of the billion times that the common tuberculosis vaccine has been used around the world since it was developed in the 1920s.

Lead researcher in the U.S. Jeffrey Cirillo said BCG — which is also used to treat bladder cancer — could potentially be available to treat COVID-19 in six months since it has FDA approval and does not need to go through the first three phases of a clinical trial, as new vaccines do. The regent’s professor of microbial pathogenesis and immunology at the Texas A&M Health Science Center said other vaccines currently being developed could take years to get through the first three phases of clinical trials.

Cirillo said Wednesday’s vaccinations went smoothly.

“We’re all very, very excited, but also nervous, because obviously we don’t want to have any problems and everybody has worked really hard to get to this point,” Cirillo said.

Clinical trial volunteers are also enthusiastic, Cirillo said, because the research presents another opportunity for health care workers to get involved in COVID-19 response efforts.

As of last week, fewer than 100 people locally had signed up to get involved, but now Cirillo said nearly 200 have expressed an interest in being a trial subject.

Cirillo said he expects there to be one or two additional 100- to 200-person vaccination sessions conducted in the Bryan-College Station area during the next week or two.

Researchers are still accepting volunteers for the trial. Interested health care workers can sign up at health.tamu.edu/bcgtrial. Volunteers must either be involved in care of COVID-19 patients or have more than 25 hours of direct patient contact per week.

Half of the subjects who are accepted into the trial are vaccinated with BCG, and the other half receive a placebo injection, Cirillo said.

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 this U.S. clinical trial effort, according to an A&M System press release. Cirillo said there are also other clinical trials for how BCG can fight COVID-19 being conducted around the world, including in Australia, the Netherlands and Germany.

In the coming weeks, Cirillo said there will also be vaccinations administered for the trial in Houston, Temple, the Round Rock and Austin areas and the Dallas-Fort Worth area. The first vaccinations in Los Angeles will begin next week, Cirillo said, and the Boston area will begin its testing in the next few weeks.

The total trial will include 1,800 participants, with up to 700 from A&M and affiliate locations.

BCG won’t prevent people from contracting COVID-19, Cirillo said in a previous Eagle article, but researchers believe it may allow 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 current U.S. death rate of about 6% down to 1% by implementing the vaccine.

The study was made possible when A&M System Chancellor John Sharp gave U.S. researchers $2.5 million to work on the project.

Dr. Gabriel Neal, clinical associate professor in the department of Primary Care and Population Health at A&M, oversaw Wednesday’s vaccinations. After volunteers received their shots, they went home with a kit to continue taking blood samples throughout the next six months, Neal said in an A&M System video.

“Health care workers are the most vulnerable at getting sick from the COVID-19 virus,” Neal said, “and so offering a treatment that protects them from the illness related to COVID-19 would be a big step forward in protecting Americans and people all over the world from the COVID-19 virus as well.”

To learn more about the trial, visit bcgbadas.org.

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