Saint Louis University researchers are enrolling volunteers in a trial to study a vaccine against SARS-CoV-2, the virus that causes COVID-19 disease. But will they be able to enroll enough African-American participants, given the skepticism that historical unethical experiments have created among minorities?
“It’s very difficult right now because of all of the mistrust, which has rightfully developed because of past egregious examples of experimenting on minority groups — and in particular African Americans — in prisons and things like that,” said Dr. Daniel Hoft, who is leading the trial at SLU’s Center for Vaccine Development.
African Americans in the St. Louis region are dying from COVID-19 at four times the rate as non-Black residents. They are also four times more likely to test positive for COVID-19 than non-Black hospital patients. Knowing these statistics, Hoft said that it is crucial that researchers study the impacts of the vaccine on the populations most affected by the pandemic.
SLU’s phase 3 clinical trial focuses on a vaccine co-developed by scientists at Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.
Both Washington University School of Medicine and SLU are participating in the trials as a part of the COVID-19 Prevention Network, a newly organized network formed by the NIAID to develop and test vaccines and treatments in the fight against COVID-19. Researchers at the two universities expect to enroll about 3,000 participants in several COVID-19 vaccine trials, with each school participating in different trials. Washington University will be opening enrollment for a different vaccine trial soon.
In the entire region, 18.8% of the population is African American. But so far, the volunteers in SLU’s Moderna trial do not reflect this number, Hoft said.
“We have to do better,” Hoft said. “We want to do better.”
However, if researchers at WashU and SLU want African Americans to participate, there are going to have to be some “real conversations” about the past, said Rebeccah Bennett, who is the community engagement and outreach lead for PrepareSTL — the joint protection and education campaign for the City of St. Louis Department of Health and the Saint Louis County Department of Public Health.
“That is a longer community conversation,” Bennett said. “The conversation has to look back to look forward. There is so much material there and a whole lot of mistrust.”
Bennett said African-American women within her own family were sterilized without their consent. A federally funded study on syphilis, known as the Tuskegee Experiment, lasted four decades, where black men were told they were receiving treatment for syphilis but instead were just given placebos — even when a good treatment was eventually discovered.
“We have to talk about the mistrust,” Bennett said. “We have to contend with the medical abuse, and all of that meets squarely with the fact that many clinicians believe that African Americans should get the vaccine first because of our disproportionate risk. If we are unwilling to have these reckoning conversations publicly, then I don’t think these trials will get the participation from the Black community that they are hoping for.”
Researchers also said it will be critically important to enroll participants who are likely to be exposed to COVID-19 or those at risk for severe disease from COVID-19, including participants over age 65.
“A safe and effective vaccine that will protect against COVID-19 is our best hope for ending the current pandemic,” said Sharon Frey, M.D., clinical director of SLU’s Center for Vaccine Development and principal investigator of the Moderna trial at SLU. “This is why it is vital that we conduct careful scientific studies to learn if vaccines like this one can prevent illness and stop future outbreaks, especially in our most vulnerable and at-risk populations.”
Researchers will evaluate the vaccine in adults 18 years and older who have no known history of infection with SARS-CoV-2. Those in the study will be randomly assigned to receive the mRNA-1273 vaccine, co-developed by scientists at Moderna and the NIAID Vaccine Research Center, or a placebo, which will be given in two injections, 28 days apart.
Participants cannot contract COVID-19 from the vaccine and will not be deliberately exposed to the virus, Hoft said. Participants are encouraged to still be cautious and follow all the social-distancing guidelines and wear masks, he said.
About 600 people have received the vaccine in Phase 1, Hoft said, and some experienced the side effects of not feeling well, particularly after the second injection.
“But it was not so bad that they couldn’t go to work,” Hoft said. “And we don’t know if those side effects were in the placebo group or not.”
Study participants will provide nasal and blood samples and may have up to seven scheduled clinic visits over the course of two years as researchers monitor their immune response. Participants will be compensated.
To learn more about participating in the COVID-19 vaccine trial at SLU, visit vaccine.slu.edu and complete the questionnaire or call 314-977-6333 or 1-866-410-6333.