Pat Iams, a 73-year-old resident of Upper Arlington, was the first patient to participate in a COVID-19 vaccine trial at Ohio State. She received the AZD1222 vaccine Nov. 10. Credit: Courtesy of the Wexner Medical Center
In the worldwide race to develop a vaccine for COVID-19 following a recent surge of cases, Ohio State has begun a vaccine trial of its own.
Pat Iams, a 73-year-old resident of Upper Arlington, was the first patient to participate in a COVID-19 vaccine trial at Ohio State, receiving the AZD1222 vaccine Nov. 10. The vaccine is co-developed by the University of Oxford and AstraZeneca, a biopharmaceutical company.
The clinical trial is being conducted through the COVID-19 Prevention Network, a global network of hospitals and labs working to complete COVID-19 clinical trials, according to a Sept. 1 Wexner Medical Center press release.
Third-stage clinical trials in the U.S. for the AZD1222 vaccine recently resumed following a temporary halt on all trials to review the vaccine’s safety after an unexplained illness from a participant of a trial in the U.K., according to an Oct. 23 AstraZeneca press release. After reviewing all safety data, the Food and Drug Administration deemed it safe for trials to resume.
“The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” Pascal Soriot, chief executive officer of AstraZeneca, said in the release. “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”
Researchers recruited 500 adults for the trial, Dr. Susan Koletar, director of the Division of Infectious Diseases at the Wexner Medical Center and principal investigator of the study, said. Their aim was to enroll a group of participants that demographically represents the entire population.
“If you look at the statistics and the prevalence of disease and the severity of disease, it’s actually staggering how disproportionately affected minority populations are,” Koletar said. “Vaccine trials need to include those populations so that we know that they work as well.”
Koletar said the study also enrolled those at a higher risk of contracting the coronavirus, such as those age 65 or older, people with existing health conditions, first responders, college students and people in congregate settings, such as nursing homes or prisons.
Koletar said participants receive two doses of the vaccine one month apart.
Participants will have follow-up visits for two years after receiving the vaccine, mostly by phone or electronic communication, Koletar said. The follow-up process includes participants filling out a daily digital diary with any symptoms or side effects.
Iams said the process is thorough — prior to the shot, she filled out consent forms, took a COVID-19 test, had a physical exam and gave blood samples.
“It’s pretty involved, but it seems really worth it if we can find something that stops the rate of COVID. It’s incredible,” Iams said.
Koletar said the vaccine uses a genetically manipulated common cold virus to trick the body into thinking it’s been infected by the coronavirus. This encourages the body to make antibodies to neutralize the virus and fight off possible infections in the future.
Early-stage clinical trials in the U.K. showed promising signs, as the experimental vaccine prompted a strong immune response with no serious side effects reported, Koletar said.
Koletar said participants were randomly selected to receive either the vaccine or a placebo treatment, and neither the participant nor the researcher will know which they received until the end of the study. She said participants will be compensated for their time.
“I think we all as a population owe a great deal of gratitude to people who participate in any clinical trials because that’s why we’ve made such remarkable advances in medicine,” Koletar said.
Koletar said a broad approach to vaccine trials will help more people at a faster rate and will take into account the many potential responses to a vaccine by different groups.
“It’s important to have options because this is a pandemic. I mean, it’s a worldwide problem,” Koletar said. “It’s unlikely that any one manufacturer will be able to really serve the world for — in the immediate future.”
Iams, an at-risk individual and former public health nurse, is also thinking toward the future. She said she wants to do her part to protect vulnerable communities from the virus.
“In this era of lockdown and everything else, it felt really purposeful to be able to do something positive,” Iams said.
