“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.”
“It’s important for me to be part of this study because I just feel that African Americans often have a mistrust in the medical community,” said Francesca Duncan, MD, a pulmonary and critical care medicine fellow who is also helping lead the study. “My hope is that through education, as well as my presence, more African Americans will be willing to participate, so that we can find a vaccine that can help everyone.”
Shortly after announcing IU School of Medicine as a site for this study, a temporary pause of the AZD1222 trial occurred across the United States to allow an independent committee to review the safety data of the Phase III trial. With the pause lifted, the IU School of Medicine study site has started enrolling volunteers.
“While the clinical hold didn’t affect Indiana participants in this study, we want to acknowledge that it’s an important part of the clinical study process,” said Brown. “The study was stopped, the issue was investigated and the study resumed when it was determined it was safe to do so.”
As part of this 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. People recruited from across the state will need to travel to the Indiana CTSI’s Clinical Research Center located at IU Health University Hospital in Indianapolis to participate, as well as attend follow-up visits for two years. Volunteers will be compensated for their time and participation. This is the only site for this study in Indiana.
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. Participants in this study are still encouraged to wear masks, practice social distancing, and follow all state and local health guidelines.
Contact: Anna Carrera
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About IU School of Medicine
IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.
About IU Research
IU's world-class researchers have driven innovation and creative initiatives that matter for 200 years. From curing testicular cancer to collaborating with NASA to search for life on Mars, IU has earned its reputation as a world-class research institution. Supported by $854 million last year from our partners, IU researchers are building collaborations and uncovering new solutions that improve lives in Indiana and around the globe.
About the Indiana Clinical and Translational Sciences Institute
The Indiana Clinical and Translational Sciences Institute (CTSI) brings together the state’s brightest minds to solve Indiana’s most pressing health challenges through research. It is a statewide partnership among Indiana University, Purdue University, the University of Notre Dame and numerous life sciences businesses, government entities, and community organizations. The Indiana CTSI engages with the public at every level of research—from basic science to patient care. It has been continuously funded by multimillion-dollar grants from the National Institutes of Health since the Indiana CTSI’s founding in 2008 and is housed at the Indiana University School of Medicine. For more information, visit indianactsi.org.