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IU School of Medicine begins final stage of coronavirus vaccine trial

INDIANAPOLIS (WISH) — Indiana University School of Medicine is calling upon 1,500 Hoosiers from across the state to volunteer for the third and final testing stage of AstraZeneca’s COVID-19 vaccine, AZD1222. 

The school joins 80 other testing sites from across the country as part of a nationwide effort to what scientists hope will finally put an end to the pandemic.

News 8 spoke with Roberto Swazo, PhD, pulmonary and critical care fellow at IU School of Medicine and clinical trial co-researcher. Swazo discussed trial specifics, the safety and effectiveness of AZD1222 known to date as well as how Hoosiers can help. Below is the complete interview:

Gillis: The IU School of Medicine was selected as 1 of 81 sites across the country to participate in this AstraZeneca/Oxford University vaccine clinical trial. How were you guys selected?

Swazo: I think part of that answer comes down to that IU School of Medicine has a great reputation nationally. We are experienced with working with large clinical trials. We get referrals from all over the state and surrounding states. We’re used to having big trials in this nature. Additionally, we have incredible faculty. For example, Dr. Brown is nationally recognized and world-renowned for her cystic fibrosis research. So, she is used to working with companies and large vaccine centers for pharmaceutical development. For her, this is really her neck of the woods and I’m just lucky to be working side-by-side with her during this COVID-19 vaccine trial.

Gillis: Health officials are saying the AstraZeneca vaccine is the most promising vaccine candidate we have to date. Can you speak to the previous results of the Phase 1 & Phase 2 trials and how the outcomes played a role in moving this research forward so rapidly? And how does the vaccine work?

Swazo: All of the information we have so far from the Phase 1 and the Phase 2 clinical trials have given us a couple of things that are really important to share. Number 1 is safety. We wouldn’t be doing this and moving on to Phase 3 if it wasn’t safe. Part of that is looking into all of the details and safety analysis. So, we wouldn’t be moving on to Phase 3 if it wasn’t safe for the general population to participate in this.

And secondly, all of the in vitro studies–meaning cellular analysis–have given us really promising results. Within 14 to 28 days after immunization, after receiving the vaccine, there is T-cell immunity, meaning our body reads the virus and is able to combat it. This not only prevents it from attaching or becoming part of the cell and preventing infection, but also if there is infection, it prevents further propagation or getting more sick from the virus itself. It’s kind of a two-fold thing.

So, all of the studies we’ve done up until now are really promising so now we’re hopeful that with recruitment our patient population will be able to replicate that data on a large scale and make sure this gets pumped out to the public, hopefully sooner rather than later. 

Gillis: Can you speak to the methods of the trial? How is this going to work?

Swazo: That’s a good question. This is a true clinical trial meaning that we’re going to have a placebo control group and a vaccine group. So, we’re looking for 1,500 volunteers–and this is coming from the entire state of Indiana–not just Indianapolis or Marion County. We’re looking for people from all four corners of Indiana. They will have to come to us at University Hospital. But we are open to anyone.

And we’re looking for those who are at risk for contracting COVID-19. Obviously, we still want people to follow social distancing guidelines and wear masks and practice good hygiene, but at the end of the day we’re looking for those who are at risk such as front-line and essential workers. We want to try and make the argument that the vaccine truly does help prevent a COVID-19 contraction. Once we get those 1,500 volunteers, they will be divided into those two groups. One group will get the vaccine in two phases and then the other group will get the placebo in two phases. Then we’ll follow them for the next two years…looking at labs, physical exams and go from there…start looking into all the data and start number crunching.

Gillis: There’s speculation that we might need two shots–an initial one and a booster. Can you talk about this as it relates to this trial?

Swazo: This will be one of those in which one group will…both groups will look identical meaning that the first day you’ll get part of that vaccine and then “X” amount of time later…it could be 28 days later…you could get a booster of that vaccine of that as well. So, the placebo group will get the placebo–meaning just a fake injection–and the same amount of time later as the other group they will also get a second “booster” or a fake vaccine injection thereafter. So, they are going to look identical, but the only difference is one group will get the true vaccine and the other will get the placebo. But we are looking into that booster vaccine as well. So, both groups will be getting a second injection dose

Gillis: Do you think we’ll have a vaccine by October?

Swazo: That’s a good question. Part of what we’re doing is expediting the process…what normally takes 5 to 10 years of work…we’re doing it in a smaller time frame. That being said, safety is still the number one concern. We want to make sure this gets done safely for the public. We wouldn’t be broaching this as a Phase 3 clinical trial if it wasn’t safe. Expediting it is important, but not at the expense of safety. So, in terms of timeline, it’s really difficult to say. Obviously, it is a clinical trial. Things happen. But we want to make sure we get this done soon, but as safely as possible. I wish I had a better number or timeline for you, but I just want to make sure we emphasize that. 

Gillis: You have the floor. What do you want to tell the people of Indiana?

Swazo: I would love to spread the message that this is a time when I think people can have an impact or have the opportunity to make an impact both statewide and at a national level. People are looking to see what they can do to help and this is going to be one of those things. We’re looking for those participants. We’re looking for people who are willing to take the time to come help us and I think this is an opportunity to really create an impact nationwide.

If we can enroll the right number of people, hopefully we can get the numbers that we need. At some point, if this is successful, we’ll be able to have our greatest shot at some sort of sense of normalcy once again. So, we need the people. We need those volunteers and we’re happy to have you. Come reach out to us and we’ll see you guys soon. 

To register as a volunteer, click here.

News 8’s medical reporter, Dr. Mary Elizabeth Gillis, D.Ed., is a classically trained medical physiologist and biobehavioral research scientist. She has been a health, medical and science reporter for over 5 years. Her work has been featured in national media outlets. You can follow her on Instagram @reportergillis and Facebook @DrMaryGillis.