Enrollment for COVID-19 vaccine trial begins at IU School of Medicine
INDIANAPOLIS (Inside INdiana Business) — The Indiana University School of Medicine in Indianapolis has begun enrolling volunteers for a late-stage clinical study of an investigational COVID-19 vaccine from AstraZeneca plc (Nasdaq: AZN).
The school was chosen in September as one of a dozen sites across the U.S. to study the vaccine candidate. IU says since that announcement, more than 3,000 Hoosiers volunteered for the study, though only between 1,000-1,500 volunteers will be selected.
As part of the study, two-thirds of the participants will receive the vaccine, known as AZD1222, and the remainder will receive a placebo. The study is a double-blind trial, which means both the participants and researchers will not know who is getting the vaccine and who is getting the placebo.
Associate Professor of Clinical Medicine Dr. Cynthia Brown, who is leading the study, said during a virtual media briefing Tuesday they don’t yet have any early results.
“We know that of course interest is at a high given some of the results that have been coming out from the other studies,” said Brown. “And we don’t really have a timetable at present for when results are going to be available because it depends upon enrollment. We have to get to an overall enrollment in the United States between 30,000-40,000 and also it depends upon case rate because you need to see a certain number of cases of COVID acquisition during the time table of the study to be able to determine the effectiveness of the vaccine.”
The study is taking place at IU Health University Hospital in downtown Indy. The school says the research team is looking to enroll Hoosiers that are representative of the demographics of Indianapolis, and people from all backgrounds are being encouraged to volunteer.
“Our focus so far has been making sure that we are bringing in a diverse population of individuals that reflects our state and we have been able to recruit about 9% Black individuals, 16% Hispanic and also bringing in older individuals and our individuals that are over the age 65 represent about 15% of our population. As we know, these groups are at high risk for more severe complications from COVID-19,” said Brown.
The volunteers are being recruited from across the state and they will travel to the the hospital to participate, as well as attend follow-up visits for two years.
One of the volunteers is Mia McLendon, a Carmel resident who spoke at the media briefing about why she decided to volunteer.
“I heard that the vaccination studies needed more of a diverse list of people to help with the vaccines,” said McLendon. “I have comorbidities where I’m overweight. I have hypertension and I just know that me participating will help other individuals that look like me or that might be reluctant in taking the vaccination and I just felt like I could help; it just seemed like a small thing that I could do rather than just sitting at home not doing anything.”
Brown says while the AstraZeneca vaccine works off a different platform than the vaccines being developed by Pfizer and Moderna, which each company says have shown to be effective in fighting COVID-19 in early study results, all three vaccines work to develop immunity against a “spike protein,” which helps coronavirus enter cells to create the disease.
“The thing that makes me very optimistic is we’re all going after the spike protein. All the vaccines are focusing on the same piece of the coronavirus,” said Brown. “So if we’re all focused on that same piece of the coronavirus, I’m very hopeful that we’ll get the same degree of immunity, but I guess time will tell.”
Just days after the IU School of Medicine was announced as one of the sites selected, the U.S. trial was temporarily paused due to an unexplained illness in a patient enrolled in the trial in the United Kingdom. That pause was later lifted.
“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.”
IU says results from early-stage trials of AZD1222 showed a strong immune response. However, Brown emphasizes there is no time frame for results from the U.S. trial due to the ongoing enrollment.