Veterans find a new way to serve: volunteering for COVID-19 study

By MARTHA QUILLIN | The News & Observer | Published: November 10, 2020

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(Tribune News Service) — As the United States honors its veterans Wednesday, medical researchers are turning to former members of the military to help in the fight against COVID-19.

Up to 60,000 worldwide participants are needed to test a possible COVID-19 vaccine, and researchers say veterans are known for their willingness to volunteer.

Since the Durham, N.C., VA Health Care System sent out a call last week, more than 300 people have expressed interest in what's being called the ENSEMBLE study, said Karen E. Hall, nurse practitioner for the infectious disease clinic at the Durham hospital. That number includes about 220 U.S. military veterans from the 27 counties the hospital serves and about 90 people who work there, some of whom also are veterans, Hall said.

The VA began enrolling volunteers Monday.

"I felt it was a perfect opportunity to basically continue to serve my country," said Frank Bray, assistant chief of the Durham VA's respiratory department and an Army veteran who served from 1984 to 1993. "This was a golden opportunity to not only serve our veterans, but also the population at large.

"A quarter of a million people have perished from this virus, and there is no end in sight. I feel it's important for us to do everything we can to help find a solution."

Called to join study

Bray grew up in western Kentucky and joined the Army right out of high school, he said. It was the mid-1980s, the country was in a deep recession and his family didn't have the money to send him to college. Ronald Reagan was president and, as Bray remembers it, "The sense of patriotism was stronger than I think it is at times now."

The Army trained Bray to be a combat medic with the California-based 7th Infantry and later a respiratory therapist at Fort Bragg's 28th Combat Support Hospital. It gave him experience he says he wouldn't take anything for now.

Bray joined the Durham VA Health Care System in February, just before the pandemic hit. Since then, he and his staff of 28 have been front-line workers fighting COVID-19, working directly with infected patients. He's been tested several times but so far hasn't come up positive for infection.

The study he'll participate in will test a vaccine developed by Janssen Pharmaceuticals, a division of Johnson & Johnson. Like other vaccines, this one is designed to prompt the production of antibodies to SARS-CoV-2, the virus that causes the human illness now known as COVID-19. The hope is that by inducing an immune response to the virus, the vaccine will prevent or reduce the severity of illness it causes.

The purpose of the study is to determine whether the vaccine is safe and effective.

The Veterans Administration said the study is the fourth large-scale vaccine study conducted in the United States in the fight against COVID-19. Johnson & Johnson said the study will be partially funded by Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health, both part of the U.S. Department of Health and Human Services.

Research on multiple vaccines

Earlier this week, drug maker Pfizer announced it has developed a vaccine that's 90% effective in preventing COVID-19.

Even with the Pfizer vaccine in the works, researchers need to continue developing others in case of problems with those vaccines or their manufacturing, said Dr. Christopher Hostler, an infectious disease and epidemiology specialist at Duke University and Durham VA Health Care System and the clinical lead for the Durham VA's COVID-19 response.

Hostler, a West Point graduate and an Army veteran, said the Durham VA has reconfigured most of its clinical spaces in response to the pandemic to reduce the spread of illness. Recently, the hospital has been phasing back in types of care that were halted in the early days of the outbreak.

The hospital has had its share of COVID-19 patients, and Hostler said they come from all age groups. The sickest typically are those the U.S. Centers for Disease Control said from the beginning would be the most vulnerable: older patients with underlying health issues such as heart disease and respiratory illnesses.

Because all kinds of people are susceptible to COVID-19, Hostler said, researchers need to test vaccines on as many population groups as possible. For this trial, Johnson & Johnson is looking for adults over age 18, and wants men and women of all races and ethnicities.

The patient population of the Durham VA is ripe with candidates, he said.

How the study will work

Participants in the randomized, double-blind, placebo-controlled study will receive an injection, which will either be the test vaccine or a saline solution. Patients and their treatment team won't know which patients get the vaccine and which get the placebo.

They will be monitored for any immediate reactions to the vaccine and for the development of antibodies to the virus. The study is expected to last up to two years.

If a safe and effective vaccine is approved before the ENSEMBLE trial is complete, Hostler said, researchers will decide whether to "unblind" the study to reveal who got the vaccine and who got the placebo in case any of the participants want to receive that or a different vaccine.

Hostler said that while anyone can ask to be considered for the vaccine trial, it makes sense to start with veterans and VA employees.

"Veterans have spent years of their lives in service," Hostler said. "They see this as a way to give back to their community, to potentially benefit science and to potentially benefit themselves and the community at large."

Anyone interested in participating in the ENSEMBLE vaccine trials can get information from Johnson & Johnson at www.ensemblestudy.com/#!/

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