IU School of Medicine Chosen for COVID Vaccine Trial

The Indiana University School of Medicine in Indianapolis has been selected
as one of dozens of sites for a COVID-19 vaccine trial. United Kingdom-based
AstraZeneca plc (NYSE: AZN) is conducting the Phase III clinical trial of
the vaccine, which researchers at Oxford University began developing in
January. The IU School of Medicine is the only site in Indiana to be
selected for the trial, and the university says the participants will be a
representative sample of the population demographics of Indianapolis.

Dr. Cynthia Brown, study site leader and associate professor clinical
medicine at the IU School of Medicine, tells Inside INdiana Business the
research team is excited about being able to contribute.

“Obviously, nothing is going to get back to normal in the world of
coronavirus until we have a vaccine and a good vaccine out there,” said
Brown. “So being able to put our efforts and bring this into the state of
Indiana where I know people are asking questions; people want to be able to
participate in vaccine trials. So the fact that we can do this, it is for
really the greater good within the state of Indiana.”

The vaccine is known as AZD1222 and is one of only four vaccines in Phase
III testing for the prevention of COVID-19 in the U.S., according to IU.

Brown says up to 1,500 volunteer participants
<allinforhealth.info/get-involved/> will be enrolled within eight
weeks when the site is activated next week. The participants must be over
the age of 18, must not have had a positive COVID-19 diagnosis, but must be
at increased risk for contracting the disease. Conditions for the latter
include working in a school, store, warehouse, or healthcare system.

“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,” Dr. Jay Hess, dean of IU School of
Medicine, said in a news release. “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.”

IU says early findings of the vaccine have shown it produces both T cells
and antibodies to fight the coronavirus, with the strongest responses being
seen in participants who receive two doses.

Brown says AstraZeneca has used the vaccine platform for other diseases in
the past and made it specific to coronavirus.

“What we can see from those early phase participants is that it looked to be
fairly safe, first of all. Most of the side effects were really mild, the
types of side effects that you would expect to see after getting a vaccine
(such as) pain at the injection site, some redness, some feeling fatigue and
feverish for a few days afterwards,” said Brown. “In addition, it also seems
to generate a good immune response.”

Brown says the Phase III trial aims to not only find similar results on a
larger scale, but also determine if giving the vaccine to a larger number of
people will ultimately prevent community spread of the disease.

A total of 30,000 people at 81 sites throughout the country are expected to
take part in the study. In Indiana, the university says people from
throughout the state are invited to participate, but must be willing to
travel to Indianapolis to receive the doses and attend follow-up visits.

IU says volunteers will be compensated for their time and participation.

The ultimate goal is to receive approval from the U.S. Food and Drug
Administration. Brown says that will come down to what the FDA accept as
evidence of efficacy.

“Some of the early markers I think we will have are evidence of how the
body’s immune response is to being given this virus and how well do
individuals produce antibodies to this virus,” said Brown. “Or, is the FDA
going to want to see longer-term information about how many cases of
patients who received the vaccine go on to get coronavirus versus those who
receive a placebo? So I think that’s a great question that the regulators
are really going to have to think hard about what type of evidence that
they’re going to require.”

Source: Inside Indiana Business with Gerry Dick

Photo courtesy of IU School of Medicine