August 21, 2020

UNC, Duke seek volunteers, particularly people of color, for COVID-19 vaccine trials

Nurses in an intensive care unit at UNC Rex Hospital put on gowns and other protective equipment before entering the room of a coronavirus patient Friday, May 1, 2020. UNC now plans to host vaccine trials for COVID-19. SCOTT SHARPE SSHARPE@NEWSOBSERVER.CO

RALEIGH BY RICHARD STRADLING

UNC Health and the School of Medicine are looking for 500 people willing to test a potential vaccine for COVID-19, one of what could be several opportunities for Triangle residents to take part in vaccine clinical trials for coronavirus in the coming months.

While the trials are open to almost everyone, researchers are particularly looking for people who would most likely show whether the vaccine works.

“We are looking to enroll the people who are at the most risk for COVID, through no fault of their own, because they’re an essential worker, the occupation they have or where they live,” said Dr. Cynthia Gay, who is leading the UNC study. “Really the risk comes down to people who are in contact with other people on a frequent basis.”

That means attracting people from groups that have generally been reluctant to take part in clinical trials in the past, particularly Blacks and Latinos. African-Americans are slightly more likely to contract coronavirus but die from the disease at a higher rate. And Hispanics account for about 39% of coronavirus cases in North Carolina, even though they make up less than 10% of the population.

Making sure these groups are well represented in a clinical trial can be a challenge, researchers say. CNN reported this week that even though Blacks and Hispanics account for more than half of COVID-19 cases nationwide, they make up only about 15% of people who have signed up so far to help test a vaccine developed by Moderna, a company based in Massachusetts.

“The communities that we really would love to have participate in this study are those who are perhaps less trustful of research in general and health systems,” Gay said during a video press conference Wednesday. “We understand that. I think our hope is that people will recognize that UNC and many other infectious disease research groups are really working for these communities.”

UNC is one of 89 sites around the country looking to enroll a total of 30,000 people willing to test the Moderna vaccine. It’s the country’s first large-scale clinical trial to test a coronavirus vaccine, but others are on the way.

The so-called Phase 3 clinical trials follow smaller-scale tests to see if the vaccine stimulates the body’s immune system without any harmful side effects and to determine the proper dose. Phase 3 involves giving either the vaccine or a placebo to large numbers of people to see if the vaccine really works.

In the Moderna trial, half of participants will get the vaccine and half the placebo, without knowing which, in two doses 28 days apart. For the next two years, participants will be asked to watch for any symptoms of COVID-19 and to check in regularly with UNC staff, mostly by phone.

Two years is needed to fully evaluate the antibody response to the vaccine, Gay said, but there will be two interim analyses to look at whether the vaccine works.

DUKE TAKING PART IN TWO VACCINE STUDIES

Duke University researchers have already enrolled about 50 people in a national study of a COVID-19 vaccine developed by Pfizer. Duke will soon begin trying to recruit up to 1,000 more for a Phase 3 trial sponsored by the National Institutes of Health to test a potential vaccine developed by AstraZeneca and the University of Oxford in England.

Dr. Emmanuel Walter, chief medical officer of the Duke Human Vaccine Institute, said researchers always want to include a diversity of people in their clinical trials, to ensure a drug works on everyone. But that’s especially important with COVID-19, where some of the best candidates to test a vaccine are front-line workers, Walter said.

“If you’re only studying the vaccine in a population that is only staying home and has no risk, then you’re not going to get infections anyway,” he said.

People interested in enrolling in the Moderna trial at UNC, or any other government-sponsored COVID-19 vaccine trial, can get more information and enroll through a national registry at www.coronaviruspreventionnetwork.org/. Registration for the Duke study will also use that website, probably starting after Labor Day, Walter said.

But both Duke and UNC researchers say they can’t simply sit back and wait to see who signs up if they want their studies to represent people most at risk for COVID-19.

Dr. David Wohl, an infectious disease expert at UNC who is leading efforts to test several COVID-19 treatments, said researchers must get out in the communities and recruit volunteers. UNC is working with African-American and Latino community groups to publicize the Moderna study and has partnered with a clinic that primarily serves Hispanics in Siler City where it hopes to meet with trial participants.

Wohl said UNC is walking a line, wanting to include people of color and those vulnerable to COVID-19 without making them feel that the burden of testing vaccines or treatments rests solely on them.

“We’re trying to be really inclusive,” Wohl said during the press conference. “We don’t want this to be just for people who read about it in The New York Times or listen to it on NPR or see it in The News & Observer. We want all different types of people to have an opportunity to say yes or no to this research.”

Wohl and Gay were asked about the “Tuskegee Effect,” the distrust of medicine and medical research among many African-Americans stemming from a 40-year study of Black men with syphilis who were intentionally denied penicillin that could have cured them.

Wohl replied that researchers are seeking to include African-Americans and Latinos in COVID-19 trials to make sure vaccines and treatments work for everybody, particularly those who need them most. Gay said that’s especially true of Latinos.

“We still hear the words ‘guinea pig’ thrown around a lot in research, but that’s not why we’re appealing to them,” she said. “We’re appealing to them because we know that the Latinx community has been the most impacted in the United States and the most impacted in North Carolina.”

People who take part in clinical trials are paid for the time and trouble of making office visits. While the rate hasn’t been set for the Duke study, UNC will pay up to $1,325, Gay said.

But both Gay and Walter say they expect most participants will have more altruistic motives.

“I think it’s a way for them to give back to the larger community and to their own communities,” Walter said.

via News & Observer