Participating in a COVID-19 Vaccine Clinical Trial

[MUSIC PLAYING] Hey, everyone. You're watching Coronavirus in Context. I'm Dr. John Whyte, Chief Medical Officer at WebMD.

We're hearing a lot of talk about the vaccine. When might it be available? Who's going to be eligible? But what's it like to actually participate in one of the trials that are going on?

Well, today you're going to find out. My guest is Stella, who's participating in one of these trials. Stella, thanks for joining me.

Oh, well, thanks for having me on.

You know, let's start off with the obvious question. Why did you decide to do it? We don't have any treatment options [INAUDIBLE] COVID. And, you know, it's-- the trial is not working. Why did you do it?

Well, I, um, you know, like everybody, I was at home in April and May. And I was, you know, following the rules and only leaving the house for essentials.

And, um, some of the things I was doing was taking care of my elderly relatives, who really, truly couldn't leave. I have grandparents in their 90s. And, um, my-- my aunt's in her 70s. And so I was shopping for them, obviously very worried about them, especially my grandparents, who were in a retirement community that did have about 16 or 17 COVID deaths.

So, um, you know, I was very worried about that. And I've always been a big believer in vaccines. And so one day I just logged on to my local health system's website to look at the, you know, case totals for my county. And I saw, um, COVID DNA trial, a vaccine trial.

And I clicked on it. And I thought, well, this would be perfect for me. It felt like, um, something more that I could do beyond, uh, you know, what everybody is doing.

And, you know, obviously, I'm not a health care professional or anything like that. I was at low risk of exposure for myself. And I'm healthy, so I sort of, I guess, felt a duty that because I have good health, and I had the time and ability to participate, that I-- I had to try.

Everybody wants to know, what's it like? How often do you have to go? How many injections did you get?

Do you have any special, you know, procedures? What's kind of the whole process? Walk us through it. What do you do?

Well, I can only talk about my own experience. I'm in the Inovio trial through Penn Medicine. And I'm a Phase I participant, which means that I did not get a placebo.

I actually got, um, a dose. There were one of three doses of the actual vaccine. Um, so what worked for me may be different than what somebody is going through for a Phase III trial.

But I will tell you that, um, my safety and my informed consent were at the heart of the whole process. Um, I felt very well taken care of. And I think, um, so there's a-- there's a-- one appointment that's literally just like an hour of them going over your medical records and consenting you.

It's a 22-page document. And they talk about everything that could happen, um, everything that you need to know, and, you know, really in plain language make sure that you understand that. The second visit was a full--

[INAUDIBLE]

What's that?

Did that frighten you, that 22 pages of what could happen?

Um, it didn't because I guess when I met, um, when I met my research nurses and I met, um, the-- the head investigator, Dr. Tebas that I felt so comfortable that they-- these were experts who have been studying infectious diseases for decades. Um, you know, these researchers were involved in trials for hepatitis C treatments, for HIV treatments. And so when you meet people who are obviously so caring, and who are obviously so well educated, and who obviously have been doing it for such a long time, um, it actually gave me more confidence that we would get a vaccine that worked, and that they were taking the safety very, very seriously.

So, no, I didn't. I felt the opposite. I felt, um, really confident, because when you're with true experts, it makes you feel good.

So that's the first time just--

Right.

[INAUDIBLE] so [INAUDIBLE] over it.

There's blood work. Oh, go ahead.

OK, blood work, OK.

Yeah, so there's blood work, um, urinalysis. I had to have an EKG. I had a full, um, physical-- very thorough physical, and was found to be in perfect health, which was very-- very reassuring. Um, and, of course, you have to have a COVID test and a COVID antibody test, because they want people who haven't ever been exposed. Um, so I was negative for both of those.

And then I went back. And my-- my first injection was June 8. Um, and that was still very early. I think there probably had only been maybe a few hundred people in the country at that point who had had a COVID vaccine of any kind. So that was pretty kind of exciting.

Um, and then, about close to four weeks later was my-- my second injection. Um, and then there's various blood draws, uh, first every 2 weeks up until about 12 weeks. And then it spaces out to every 16 weeks until we get out to a year.

Every two weeks, you're going in for blood, blood [INAUDIBLE].

Only at the beginning, for the first three months or so. And then it spaces out after that, yeah.

OK, all right.

Yeah.

And how are you feeling?

Um, I feel fine. I, um, had-- after the-- the first, uh, vaccination, the-- the next day, I felt a little bit of fatigue. But when I say fatigue, I mean I was still going about my normal day, taking care of my kids, making dinner. You know, I exercised.

I just, like, noticed, eh, I'm kind of tired. Like, and I went to bed about an hour early. So, I mean, if that's the worst that happens [CHUCKLES] that's not really a big deal at all. Um, and then after the second vaccination, I really didn't feel anything. So I guess for me, it would be the same as like, mm, a mild reaction, like how I felt after getting-- getting a flu vaccine sometimes.

So two shots.

Mm-hm.

JOHN WHYTE: Any special precautions, either for you or your family members, people that you--

Well, I can't-- so a big part of, um, the-- the vaccine is that, um, they're really just trying to make you immune to the spike protein. Um, and they're using the DNA of the spike protein that's been synthesized to, um, stimulate your-- it goes into your skin cells, and then stimulate your immune system to make antigens to that spike protein. So, um, it doesn't contain any of the actual virus.

Um, and therefore, it couldn't make me contagious. And it couldn't actually give me COVID. So I felt very comfortable, um, having the science explained to me that I knew that I-- I couldn't endanger my family in any way or anybody that I came in contact with.

So for me, um, it's really just a matter of following the same rules that everybody else has to follow right now, because, um, because I'm-- people ask me a lot, well, wouldn't it help them know if you got exposed, and then you didn't get it? And it's like, well, actually, no, they don't want me to get exposed, because they want, um, when they look at my blood, they want my immune system to really only be showing the effects of the actual vaccine and not any wild exposure to COVID because that would actually screw up their data. So, um, so, no, I-- same-- same rules as everybody else.

Now, there's a lot of discussion that many people in the public feel that the vaccine is being rushed. They're not going to take a vaccine, certainly not early on, uh, if it does become approved or authorized soon. What's your message to those persons who are skeptical about a COVID vaccine?

Well, I, um, understand why they feel that way, um, because, you know, it is something that we-- we think of vaccines taking a long time to develop. Um, but I would say that what I learned in the process of being a volunteer is that there actually had been a ton of research on making coronavirus vaccines for SARS and MERS that occurred over the last, um, two dec-- well, at least for SARS, over the last two decades. And so there were really experts in coronaviruses who had been experimenting with this vaccine for a long time. Um, the company that made my vaccine has a MERS vaccine that's in, um, I think Phase III trials in the Middle East. And so because they had so much experience with related vaccines, it was, um, a fairly quick process for them to-- to pivot to, um, this new-- new coronavirus.

So I guess to me, I don't look at it as a brand-new vaccine. I look at it almost like how, um, the flu vaccine has to be changed a little bit every year, um, because there's new flu strains. And this is sort of building on that, that same thing. So when I learned about how much research has already gone into creating a coronavirus vaccine, that made me feel more confident.

And the second thing is I would say, um, they're, you know, they're working 12-hour days to get people through these trials as fast as possible. But they're not rushing our safety. My trial nurse, I can text him at any time and say, oh, my arm itches, like, you know, or whatever. And they have to write that down.

And that's very, um, you know, they take all of that very seriously. So I don't think that the science or the safety is being compromised. I think that we are benefiting from, um, a whole body of scientific knowledge that most people didn't know existed, um, that was there, sort of ready-- ready to save us when this coronavirus came out.

Now, you've been documenting your journey on Instagram. Is that right?

Yep. Yes, I have. Um, it's been a lot of fun. And I've gotten a lot of really positive feedback.

Um, you know, people ask really good questions. And, um, you know, I'm just trying to help people understand that, um, even though it seems like a new process, that I-- I really have confidence that it's a safe process. Um, my trial, actually, the FDA just held up the-- the-- the Phase III-- progression of Phase III for my trial because they had some questions about the device that's used to administer the vaccine. And while that's frustrating at, you know, on an emotional level, I would love to see the vaccine that I tested, you know, be first. It's not going to be first.

But, um, I think that, uh, that shows that the FDA is being-- still being really careful. Um, and they have put also the brakes on the AstraZeneca one while they look into things further. That doesn't mean it's not going to go forward.

There were no-- as far as I understand, there were no, um, serious reactions in my vaccine trial. But I-- I am seeing the FDA put the brakes on things and-- and still really review and be careful. So I would say, have confidence, um, when it comes out that if it's recommended for your group, that it's going to be OK to get it.

Well, Stella, I want to thank you, first of all, for participating in a trial, and for coming on, and taking, you know, our questions. And we'll follow you on--

Absolutely.

And, uh--

Thank you.

Terrific. And thank you for watching Coronavirus in Context. I'm Dr. John Whyte.