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Last month, it was announced that the University of Vermont Medical Center and Vaccine Testing Center at the University of Vermont's Larner College of Medicine had been selected to participate in a Phase 3 trial for an Oxford University-AstraZeneca COVID-19 vaccine.Phase three is the final phase in the vaccine testing process, the trial launched last Nov. 10. Vermont Edition spoke with one of the researchers involved about where this local trial fits in the global search for a coronavirus vaccine.

Our guests are:

• Dr. Kristen Pierce, infectious disease specialist at the University of Vermont Medical Center

Broadcast live on Tuesday, Nov. 17, 2020 at 1 p.m. Rebroadcast at 7 p.m.

VPR’s Jane Lindholm spoke with Dr. Kristen Pierce, a clinical infectious disease specialist at the University of Vermont and a sub-investigator for the trial. Their conversation is below and has been edited and condensed for clarity. Listen to the full episode, here.

Jane Lindholm: Let’s first talk about what the trial that University of Vermont Medical Center and Larner College of Medicine are participating in actually is. What is this trial?

Dr. Kristen Pierce: Yes. So this is as you said, this is AstraZeneca’s vaccine, also known as the Oxford vaccine, because it was developed by researchers at Oxford University in England. And this is, as you said, a Phase 3 study. This is a national and international study, so it's conducted in the U.S. and also in sites in India, Brazil, South Africa and it is ongoing in England as well.

The hope is to enroll 30,000 volunteers in the U.S. alone. In this Phase 3 study here in Vermont, we are hoping to enroll about 250 people � that's what we've been asked to enroll by the study's authors.

And do you have all of them?

Not yet. But the response after the initial press announcement at the governor's press conference a couple of weeks ago has been overwhelming. The Burlington and Greater Burlington community is an amazing, globally-minded community, and we've had an overwhelming response and interest in the study, so that's really been phenomenal.

Are you still looking for more volunteers, or is that part of [the process] closed at this point?

No, we're still looking for volunteers. So if people are interested: Yes, please, we're still looking for volunteers.

And you're looking especially for people who have comorbidities, who have other health issues, or who are older and presumably more vulnerable to COVID-19? Talk a little bit about who you're actually hoping will enroll in this, or what types of people within the population you need more volunteers from.

We're looking for people who are most at risk of getting COVID � so COVID exposure � and also at risk for developing complications from COVID, so severe disease.

So those would be: frontline health care workers; essential workers; older people, people over the age of 60, 65; people with underlying medical conditions, things like diabetes, heart disease; underlying lung diseases, like emphysema or asthma.

And are you looking for members of different racial and ethnic communities as well?

Yes, and COVID has disproportionately affected many of those communities, in terms of illness and disease and morbidity and mortality. The hope is to really make sure that all populations � anyone that wants to be included in the study � is offered the chance to enroll and be part of the study.

So can you tell us about what a study participant is doing? They’re either getting the vaccine or a placebo, right?

Correct. And people are randomized, so allocated to receive either a placebo or a vaccine. And we, at the University of Vermont Medical Center, don't know what people are getting. That is conducted by the study sponsors. So we don't know who receives what. And it's a ratio of 2:1.

So for every two volunteers who receive the vaccine, one person receives the placebo, which is basically a saline injection, so not active drug.

Just to be clear, the participants will be informed, once the study is completely over, about which one they had, so they can make better, informed decisions for themselves?

That is absolutely correct. Yes.

What we've been hearing about at least two different vaccines, I believe, is that these types of studies are showing remarkable promise; a remarkable effectiveness rate. As I understand it, the effectiveness rate that's needed for approval is at least 50%. And these two are showing initial results much higher than that; a much higher rate of success.

How does the vaccine trial that UVM is participating in coincide with, or work or conflict with these other vaccine trials we've been hearing about?

Yeah, that's such an important question. And I will say, when the initial Pfizer results were announced, one of the main researchers at the National Institutes of Health who is part of this COVID research network, said, “It's a wonderful day for science,� recognizing that any vaccine that we can bring to market that's safe and effective in this global pandemic is going to feel like a huge win for the world of science.

I think what these two studies so far � the and the � have shown us, is that the technology that we're using to develop these vaccines, using that spike protein, that piece of the genetic material, a piece of the COVID virus itself as part of these vaccines, is working.

And that is huge. It's a huge, huge success, if you will, for vaccine science.

I think that it's important to recognize we're probably going to need more than one vaccine.

If you look at the Pfizer vaccine, although very, very effective, it has to be . So that might be a great vaccine for a large medical center that has a freezer that can keep something that's very, very cold, but that might not work for rural hospitals or small community outreach clinics.

So we don't see it as a competition; we see it as an overall win for science that these vaccines are working.

So in other words, you're still continuing on with this trial. And, the fact that others may be even closer to market than the Oxford vaccine is not a problem, given what we know about the entire population of the world that is going to try to get vaccinated?

Right. I don't have a crystal ball, but in hearing other people talk about when � something like Pfizer’s or Moderna’s vaccine might be available for the initial rollout, I don't think anyone's estimating at beyond, maybe, the beginning-to-mid-2021 for the most vulnerable.

And then, it could be even later for those populations that are not as vulnerable to severe disease. Again, I don't have a crystal ball, but it doesn't seem like it's going to be tomorrow.

Dr. Pierce, has the that's affecting so many systems at UVM Medical Center affected your trial as well?

Yes�. the cyberattack definitely impacted our ability to contact people [who have reached out as volunteers for this vaccine trial], and our phone systems went down. Most of the study documentation was supposed to be electronic, and just like the hospital has done, we've pivoted to paper.

We did it very quickly with the support of UVM Medical Center, but it definitely has affected our ability to get back to people. So please be patient. We will get back to you, I promise.

Dr. Pierce, given how fast these vaccine trials are going, how much confidence do you have that a vaccine would have long-term effectiveness? Or will there need to be more studies done to see if people need further doses?

That's a great question, Jane. I think [with regard to] the dosing piece, we don't know yet.

We don't know if this will be something that you get once and, like a measles shot, [once] you get it, you're good, or if� it will be similar to the annual influenza vaccine, where you have to get a COVID shot every year. We don't fully know that. The longer-term studies will help us figure that piece out.

I will say, a lot of attention has been paid to the pace of this vaccine development. And it has raised, I think, questions in the community about whether these vaccines are safe.

And I would just like to say: it's very important to point out that the pace of the vaccine development is more accelerated than we've seen in the past. But this is an unprecedented event.

The entire globe is looking for an effective and safe vaccine. The amount of scientific person power that has gone into this is enormous.

And just because the process has been � sped up a little bit, I also think it's important to note that the normal safety checks that are in place for any therapeutic development � a drug, a device, a vaccine –have not been tampered with.

The safety checks are, if anything, more stringent because there's so much focus and attention paid on this.

So I myself would feel comfortable getting any one of these three vaccines that are out so far. And I would say that for my family members as well.

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