Indiana University School of Medicine (IU) has been selected by the Operation Warp Speed supported AstraZeneca-sponsored Phase 3 clinical trial investigating one of the top vaccine candidates worldwide known as AZD1222. Originally developed at University of Oxford, the pivotal and closely watched Phase 3 clinical trial comes to Indiana as the Clinical Research Center at IU Health University Hospital gears up to conduct the study. With extensive ties to communities across this sprawling midwestern city, high hopes exist for IU to meet minority and at-risk participant recruitment targets.
The Vaccine Candidate
A team of scientists at Oxford University in England started developing AZD1222 in January. Early findings show the vaccine produces both T cells and antibodies, which combine for a strong immune response:
- The T cells, which are white blood cells that can attack cells infected by the coronavirus, develop within 14 days of receiving the vaccination.
- The antibodies, which neutralize the coronavirus so that it can’t infect cells in the first place, develop within 28 days of receiving the vaccination.
Researchers say the strongest immune responses have been seen in participants who received two doses of the vaccine. Oxford University announced its partnership with AstraZeneca in April.
AstraZeneca is responsible for development and worldwide manufacturing and distribution of the vaccine. AstraZeneca’s initial response is expected to include at least 400 million doses, and the company has the capacity to expand that to 2 billion doses.
In May, the U.S. Department of Health and Human Services announced plans for the Biomedical Advanced Research and Development Authority to provide up to $1.2 billion in support for AZD1222 as part of Operation Warp Speed, with plans to make at least 300 million doses of a coronavirus vaccine available to people in the United States.
In addition to providing vaccines to people in the United States and Europe, AstraZeneca is planning to supply vaccines to low- and middle-income countries around the world, at no profit during the pandemic.
AstraZeneca recognizes that the potential vaccine may not work, but it is committed to progressing the clinical program with speed and scaling up manufacturing at risk.
Biopharmaceutical company AstraZeneca, in partnership with Oxford University, is moving forward with its late-stage clinical trial for a vaccine known as AZD1222. This Phase III clinical trial is the last required stage of study before the potential vaccine can be approved by the Food and Drug Administration for widespread public use. AZD1222 is one of only four vaccines in Phase III testing for the prevention of COVID-19 in the United States.
“It is an extraordinary opportunity for the Indiana University School of Medicine to be selected as a participating site in this vital late-stage clinical trial and to help advance the testing of this extremely promising vaccine candidate in the fight to eradicate the COVID-19 disease,” IU President Michael A. McRobbie said. “This is collaboration and engagement of the kind in which Indiana University and its world-class School of Medicine have always been a leader. We are extremely proud that our leading medical experts are joining together with scientists across the country to contribute to this critical study and bringing us a step closer to eliminating this deadly disease.”
“Throughout this pandemic, our doctors and researchers have been on the front lines, working to treat those suffering from COVID-19 and investigating ways to stop its spread,” said Dr. Jay L. Hess, dean of IU School of Medicine and IU’s executive vice president for university clinical affairs. “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 a part of a study that, if successful, could help scientists turn a corner on combating this disease.”
Researchers plan to enroll a total of 30,000 participants at 81 different sites around the United States for this study. The IU School of Medicine site, which will be housed within the Clinical Research Center at IU Health University Hospital, is the only site in Indiana for the study. People from across the state are invited to participate, but volunteers will need to travel to Indianapolis to receive two doses of the vaccine or placebo as well as attend follow-up visits. Volunteers will be compensated for their time and participation.
Indianapolis Trial Site
The study site is led by Dr. Cynthia Brown, an associate professor of clinical medicine at the IU School of Medicine. She plans to enroll up to 1,500 volunteers within eight weeks when the site is activated in mid-September. The volunteer participants will all be over the age of 18 and must not have had a positive COVID-19 diagnosis, but must be at increased risk for contracting COVID-19, such as working in a school, store, warehouse or health care system. Those interested in participating in the study can sign up to receive updates by joining the All IN for Health volunteer registry.
Participant Enrollment: Studies Need Minority Participation
The volunteer participants selected will be a representative sample of the population demographics of Indianapolis. “We have an ambitious goal, given the magnitude and scope of this study,” said Tatiana Foroud, executive associate dean for research affairs at the IU School of Medicine. “While many of the clinical trials we conduct typically enroll a fraction of what we are expecting in this case, we have the infrastructure in place to successfully complete our segment of the study, adding valuable insight about the potential for a vaccine’s efficacy among people in Indiana.”
“Our research team has developed thoughtful partnerships through the years with minority groups across Indianapolis, which we plan to engage as we begin the enrollment process,” Brown said. “Nearly 40 percent of the city’s population is made up of Black, Hispanic or Asian people, and we know how important it is to include participants from as many backgrounds as possible as we work to determine the best preventative treatment for this terrible pandemic.”
Indianapolis has grown into the 17th most populated city in the United States with 876,000 inhabitants. The city has a sizeable African American (28%) and Hispanic at about 10%). Many of the same health equity and disparity issues plaguing other parts of the nation exist here as well. IU’s connection to communities of color and other at-risk groups across this sprawling midwestern city will be key for study recruitment targets.
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 and 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.