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Indiana University School of Medicine announced today that several Hoosier volunteers are now enrolled in the late stage clinical study of an investigational COVID-19 vaccine known as AZD1222, taking place at IU Health University Hospital. Within days of announcing IU School of Medicine as one of the study sites, more than 3,000 Hoosiers created volunteer profiles through All IN for Health, a program of the Indiana Clinical and Translational Sciences Institute (CTSI).

COVID-19 vaccine study underway at IU School of Medicine

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Thousands of Hoosiers stepped up to participate within days of the study being announced.

INDIANAPOLIS – Indiana University School of Medicine announced today that several Hoosier volunteers are now enrolled in the late stage clinical study of an investigational COVID-19 vaccine known as AZD1222, taking place at IU Health University Hospital.

Within days of announcing IU School of Medicine as one of the study sites, more than 3,000 Hoosiers created volunteer profiles through All IN for Health, a program of the Indiana Clinical and Translational Sciences Institute (CTSI). The Indiana CTSI is a research partnership among Indiana University, Purdue University and the University of Notre Dame, created to educate the Indiana public about health research, including clinical studies, like the COVID-19 vaccine clinical trial.

“We would like to thank the more than 3,000 Hoosiers who signed up as volunteers to participate in this vaccine study,” said Jay L. Hess, MD, PhD, MHSA, dean of IU School of Medicine and IU’s executive vice president for university clinical affairs. “Your commitment to helping us advance life-saving medical research is deeply appreciated and valued.”

The Indianapolis-based site is led by Cynthia Brown, MD, an associate professor of clinical medicine. As Brown’s study team looks to enroll more than 1,000 volunteers in eight weeks, they are screening the All IN for Health database to select participants that are representative of the demographics of Indianapolis. Because COVID-19 has disproportionately affected Black and Latino families, study leaders are encouraging people from all backgrounds to join the study.

(View a Spanish version of this video.)

“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
acarrer@iu.edu, 614-570-6503 (cell)

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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.