Vanessa Clayton’s story about clinical trials participation differs from most, as she was first approached to participate by her husband, Reverend Elvin Clayton, the pastor of the Walters Memorial AME Zion Church in Bridgeport, Connecticut and Cultural Ambassador to clinical research at Yale. Like many people of color, Mrs. Clayton was worried about the disproportionate impact of the COVID-19 virus on black and brown individuals. When her husband told her about the Phase 3 randomized and placebo-controlled trial looking to test the safety, tolerability, and immunogenicity of the SARS CoV 2 RNA vaccine against COVID-19, she did not immediately say yes. She decided to do her own homework to understand the research and also wanted to discuss it with family members in the health profession. Ultimately, after speaking to the study PI, Dr. Onyema Ogbuagu, and reviewing the informed consent, she decided to join her husband and hundreds of other Connecticut residents enrolling in the trial.
Although busy with her many social and civic responsibilities as the first lady of a large and very active church, as a recent retiree, she felt that with fewer responsibilities, this was one of the most valuable ways she could choose to spend her new-found free time—participating in trials that will benefit her community. She is adamant that everyone should do their part to help stop the spread of COVID-19 and felt good about enrolling in the vaccine study. Vanessa shared, “I was deeply concerned about how disproportionately minority community members are being affected. This will continue unless people step up”.
Eligible participants for the study received either a placebo or the study vaccine. They had to check in daily to report any side effects. Participants did not know whether they received the placebo or the real vaccine, but all were assured that placebo recipients would be first in line to receive the real vaccine once FDA approved. This was something that really resonated with Vanessa. She was happy that she could help the community, scientific discovery, and herself at the same time. She and her husband feel so strongly that everyone must have access to the vaccine once it becomes available and to take the necessary steps to get vaccinated.
In January 2021, the study was unblinded. Although Vanessa found out she did not get the vaccine as part of the study, she was thrilled to learn her husband had received the vaccine during the trial. She has no regrets, “I was happy that I took a step to do something to help the community, scientific discovery, and myself at the same time,” she said. She plans to get vaccinated as soon as she is offered the opportunity and feels great about her contributions to medical discovery.
In December, 2020, the U.S. Food and Drug Administration issued emergency use authorization (EUA) for the first two COVID-19 vaccines, for the prevention of disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 or 18 years of age and older.