IU School of Medicine provides update on AstraZeneca COVID-19 vaccine trial

Coronavirus

INDIANAPOLIS– Officials with the Indiana University (IU) School of Medicine provided an update Tuesday afternoon on their progress made after being selected as a site for the AstraZeneca COVID-19 vaccine trial.

Dr. Cynthia Brown, the doctor leading the study, gave updates and introduced volunteer participants, who shared their experiences. You can watch the presentation above.

Shortly after announcing IU School of Medicine as a site for the study, a temporary pause of the trial occurred across the United States to allow an independent committee to review the safety data of the Phase III trial. The pause has since lifted.

The IU School of Medicine says several Hoosier volunteers are now enrolled in the late-stage clinical study of an investigational COVID-19 vaccine known as AZD1222. More than 3,000 Hoosiers applied within days of the local study site being announced.

Brown’s team looks to enroll more than 1,000 volunteers in eight weeks. Because COVID-19 has disproportionately affected Black and Latino families, study leaders are encouraging people from all backgrounds to join the study.

As of Monday, researchers say roughly 200 Hoosiers have received the first of two doses for the vaccine trial. So far, side effects have been reported to be mild, like low fever and other symptoms one might expect with a flu vaccine.

Mia McClendon, an IT consultant and mother of two, said she hopes her participation in the study will help end the COVID-19 pandemic.

“I have co-morbidity where I’m overweight, I have hypertension, and I just know that me participating will help other individuals that look like me,” McClendon said.

Joe Morris, a 79-year-old retiree, says he misses going to the gym and having lunch with the “Romeos,” which stands for “Retired Old Men Eating Out.”

“I feel that it is the very thing that a person of my age can do to help change things and get my children back to work, my grandchildren back to school and be able to enjoy the things I’ve always taken for granted,” Morris said.

“We’ve seen the travesties,” said Roberto Swazo, MD, a pulmonary and critical care medicine fellow who is helping lead the study. “The coronavirus has affected millions of people worldwide. I think we owe it to everyone to try and be part of the solution and we’re hoping this clinical trial will have a positive impact here at home.”

In the Phase III study, two-thirds of participants will receive the AZD1222 vaccine and the remaining one-third will receive a saline shot as the placebo. As a double-blind trial, neither the participants nor the researchers know who is getting the vaccine and who is getting the placebo.

Participants will attend follow-up visits for two years and will be compensated for their time.

The IU School of Medicine say results from early-stage trials of AZD1222 show a strong immune response, producing both T cells and antibodies, which can find and attack virus cells.

However, it will likely be more than two months before researchers have enough data to evaluate the vaccine’s effectiveness and safety.

Participants in this study are still encouraged to wear masks, practice social distancing, and follow all state and local health guidelines.

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