Researchers at the Indiana University School of Medicine will be looking for volunteers to receive a two-round COVID-19 vaccination when the trial resumes in the United States.
The trial comes to the school via a partnership between biopharmaceutical company AstraZeneca and Oxford University. The vaccine, AZD1222, is one of only four vaccines currently in the third — and final — stage of clinical trials to prevent COVID-19. The trial has been temporarily halted in the United States due to one patient getting sick, although it is not yet known if the vaccine caused the illness.
“Throughout this pandemic, our doctors and researchers have been on the frontlines, working to treat those suffering from COVID-19 and investigating ways to stop its spread,” said Dr. Jay L. Hess, dean of the IU School of Medicine. “Never has that work been more important, and our leadership continues with this crucial study taking place right here in Indianapolis. The Hoosiers who participate will have the chance to be part of a study that, if successful, could help scientists turn a corner on combatting this disease.”
Dr. Cynthia Brown, the lead researcher for the trial, said volunteers will be closely monitored to test the effectiveness and the risks of the vaccine. Researchers are also looking to make sure the test group is representative of the community. However, Brown said she understands why Black and brown communities would be skeptical of a vaccine, especially one that was developed so quickly.
“I hear your concerns,” Brown said. “Historically, there has been mistreatment of minorities in trials, absolutely. But patient safety is first and foremost in any clinical trial.”
Brown said recipients of the vaccine will meet with a researcher 28 days between the first and second round of the vaccine, and again 90 days after the first dose. Patients will also be able to speak on the phone with doctors about any possible side effects from the vaccine.
“I think this definitely has been a faster process in drug discovery and development,” Brown said. “The government put a lot of money in development, and regulators are going to have to take a careful and close look.”
Much of the early work for this vaccine was done in the United Kingdom, where 500 people received the vaccine in July. Researchers in the UK found a second dose of the vaccine boosted response. Brown said some of the most common side effects were standard for most vaccines, swelling or pain at the injection site and fatigue. Thirty thousand Americans are expected to participate in this trial.
To be included in the study, participants cannot have tested positive for COVID-19 in the past. Although there are still many unknowns surrounding the virus, it’s believed that if you’ve had it in the past, you likely have some degree of immunity.
When enrollment resumes, researchers will use All In for Health to find registered volunteers. Brown said they’re looking to bring in volunteers as quickly as they can and to get a sizeable, diverse enrollment.
“Historically, minority populations have been underrepresented,” Brown said. “Looking at our sample of volunteers, we’re trying to oversample Black and Hispanic people to bring more minorities in. In the big picture, Black and Hispanic communities have had greater complications [from COVID-19]. And, our recruitment team has a good background, and we’re going to try to focus in on those communities early on.”
Contact staff writer Breanna Cooper at 317-762-7848. Follow her on Twitter @BreannaNCooper.
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