African American participation in clinical trials is invaluable to medial research and is essential in helping reduce the health care divide in America.
“Vaccines are now available for prevention of COVID-19. However, because the virus is changing itself to become more transmissible and sometimes more deadly, we should not lose focus and should continue our endeavors to bring forth improved vaccines.”
Not all treatments for various illnesses are the same for all people. The larger number of Black volunteers in clinical trials, the greater chance of finding the right path to proper treatments for Black patients.
St. Louis University researchers are enrolling volunteers in the second stage of a Phase 1 vaccine trial designed to test safety, tolerability, and immune response to second-generation COVID-19 vaccines.
People who have received a primary vaccination series of either an approved mRNA (Pfizer or Moderna mRNA) or the approved Johnson & Johnson recombinant adenovirus (Ad.26) COVID-19 vaccine and a single booster vaccination (with an mRNA vaccine are eligible to volunteer.
Those who have already received a second booster vaccination against SARS-CoV-2, the virus that causes COVID-19, are not eligible.
Minority participation important
In April 2022, the U.S. Food and Drug Administration [FDA] release its “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials” guideline.
“Race and ethnicity can serve as surrogates for biological differences in drug response. For instance, race-based differences in the metabolism and disposition of some drugs due to genetic variations have been identified. These differences can require alterations in drug dosing to achieve the desired result,” the FDA states.
However, “the makeup of clinical trial participants remains biased for the white population.” In February 2021, the FDA reported the demographics of clinical trial participants involved in 53 drug approvals in 2020. It found that 75% of the 32,000 patients enrolled were white, whereas 8% were Black or African American, 6% were Asian, and 11% were Hispanic.
The FDA calls its report, “an important effort to address inequities by increasing participation of underrepresented populations in clinical trials and ultimately improving our nation’s health in the face of changing demographics.”
Making new vaccines
The investigational COVID-19 vaccines being researched are different from current approved vaccines and could provide advantages over boosting with one of the approved vaccines. They are designed to elicit an immune response to multiple SARS-CoV-2 proteins, in addition to the spike protein targeted by currently available vaccines made by Moderna, Pfizer and Johnson & Johnson.
The vaccine trial is also designed to elicit more extensive T cell responses, which are not elicited by the approved vaccines.
According to researchers, targeting several coronavirus proteins, could lead to future vaccines that could enhance protection against a wide variety of SARS-CoV-2 strains and variants.
“We need to develop new COVID-19 vaccines that can protect against future SARS-CoV-2 variants that develop which the investigational vaccines we are studying in this trial have the potential to do, while providing protection in the form of T cells,” said Dr. Daniel Hoft, professor of medicine, molecular microbiology and immunology, director of the Saint Louis University Center for Vaccine Development.
According to Getahun Abate, M.D., principal investigator for the trial at SLU, “great strides have been made in overcoming the initial havoc caused by the COVID-19 pandemic.”
“Vaccines are now available for prevention of COVID-19. However, because the virus is changing itself to become more transmissible and sometimes more deadly, we should not lose focus and should continue our endeavors to bring forth improved vaccines.”
“We want new vaccines that give protection against circulating and newly emerging strains as well as provide a long-lasting immunity. To achieve these goals, we want volunteers who already received EUA or approved COVID-19 vaccines to participate in an ongoing investigational vaccine study at Saint Louis University,” Abate said.
How to participate
To enroll, participants must be older than 60 years of age, healthy, without significant allergies, and have been vaccinated and boosted once against COVID-19 at least four months prior to enrollment.
Participants will be asked to:
• Make 9 to 14 or more study clinic visits in-person and will also receive one to two telephone check-ins with the study staff over 12 to 14 months.
• Receive one or two injections of an investigational booster vaccine.
• Have blood drawn several times for safety monitoring and to see whether the vaccine resulted in an immune response.
• Keep track of how they’re feeling after the injection.
Interested participants should contact: The Saint Louis University Center for Vaccine Development at vaccine@slu.edu, or call (866) 410-6333
For more information about the trial, visit ClinicalTrials.gov. The study’s Clinical Trials Identifier is NCT04776317.
For more information on the FDA effort to increase minority participation in clinical trials, visit fda.gov.
