OTR Interviews

Inside lab where the Ebola vaccine is being tested

Greta tours the Walter Reed Army Institute of Research in Maryland, where an Ebola vaccine is being tested on 39 healthy volunteers. #Ebola


This is a rush transcript from "On the Record," October 16, 2014. This copy may not be in its final form and may be updated.

GRETA VAN SUSTEREN, FOX NEWS HOST: The first Ebola vaccine test on humans in the United States has just started at the Walter Reed Army Institute of Research in Maryland. And today, we went inside that research lab to find out more about the vaccine being tested on 39 healthy volunteers.


VAN SUSTEREN: Can you get Ebola from the vaccine?




VAN SUSTEREN: All three of you say no.


VAN SUSTEREN: That's a great sign.

THOMAS: That is good.

VAN SUSTEREN: How do you know if it's successful?

REMICH: Well, to know if it's successful or not would require a challenge. That's something we can't do on the individuals. So right now we have preclinical data we're going to use. And that's been encouraging. It doesn't necessarily predict what's going to happen with real people.

VAN SUSTEREN: I understand this is a Canada vaccine. Is this a Canadian vaccine, originally, is that correct?

THOMAS: It's got a complicated pedigree.


VAN SUSTEREN: 100 percent successful in animals, right? So far?


VAN SUSTEREN: But that doesn't necessarily mean it's going to be for humans?

THOMAS: Right.


THOMAS: Well, there's the saying, so mice and rodents sometimes lie a lot and monkeys sometimes lie a little less, because they don't always translate to what the human experience is. And so although it can inform decision making and it can help us choose a certain pathway of development, the only way to truly know what the human experience is going to be and what the response to the vaccine and response to a natural infection will be is to do trials in humans and in places that the disease is pandemic and circulating.

VAN SUSTEREN: Which brings me back to my question. If someone goes through the experimental vaccine after some period of time and the person is gone through whatever you have to, how do you know the person is immune from Ebola? Is there a test you can do on the person?

LT. COL. JASON REGULES, EBOLA VACCINE PRINCIPAL INVESTIGATOR, WALTER REED ARMY INSTITUTE OF RESEARCH: So we will get what we call, you know, immune testing. Look at antibodies. Look at how the cells in their body react to the vaccine. Again, we can compare those to the animal studies. We won't be able to say for sure that they are immune. We'll have a good idea based on reactions and immune profiling from other vaccine studies that we measurements are suggestive of immunity, but as the colonel was stating, we really have to compare to either animal studies or studies in endemic areas where people are exposed to these diseases.

VAN SUSTEREN: When you say good idea, can you be like 80 percent sure or 90 percent sure or 50 percent sure? What's a good idea that the person will be?

You shake your head.


THOMAS: That's the million-dollar question. It really depends on what type of vaccine you're working on, what the past experience has been with that vaccine. In this particular case, with this particular Ebola vaccine, we don't have a test that we know, yes, this predicts a human will be protected against the natural Ebola infection. We don't have that available to us. As Jason was saying, we have to make inferences and educated guesses about how this is how the person's immune system responded. We think this can be predicted. And in discussions with FDA and in the discussions with the sponsor and other regulatory authorities, it merits going onto the next step or phase of testing.

VAN SUSTEREN: Could it be you and I both take the vaccine, and it might be successful for you and not for me?

THOMAS: It's possible.

VAN SUSTEREN: So it varies from person to person?

REMICH: It does. For each individual, it boils down to risk and reward.

VAN SUSTEREN: Why do you pick 39? Any reason?

REMICH: That's a common number for phase one clinical trial.

VAN SUSTEREN: Not 40. Not 35?


REMICH: Well, the way this particular trial was constructed we'll have time to get the vaccine in each of the groups and three placebos, so it's really driven by the placebos.

VAN SUSTEREN: So explain how it happens. They showed up Monday, right, to get the vaccine, all 39. Some got placebos, right?

REGULES: Yeah. So the way this study is designed, we have three different dose levels. Again, the study is designed for safety. We want to make sure that the vaccine is safe, and, you know, and that kind of drives the smaller size of the study. Again, safety is priority number one. So what we do is a staggered start, start with a few number of individuals, two or three on the first day, see how they do. If they do fine, bring in another few people the next day or two, vaccinate them. Watch the first group for approximately a week. If they do fine, we do the rest of the individuals in that dose cohort of people, so in total, 13 people. Then we'll present the safety data to an outside independent committee to review it. The decision is typically fairly quick, if people have tolerated the vaccine well. They'll look at the data and say it's OK to increase the level and start with higher dose level and repeat the process again.

VAN SUSTEREN: What is the term of this? How long is this trial period going to go on for testing vaccines? Assuming everything is successful as you go along and they don't get any obstacles, is it a month long, two months, three months?

REGULES: The total study duration is six months to follow people from time of vaccination until final follow-up to see how their immune responds and see how their safety profile looks over a six-month period. We could potentially, if everything were to go perfectly, inject people within the first, say, approximately two months. But there's always variables in being able to determine that. So two, maybe three months.

VAN SUSTEREN: Is that standard with a vaccine? You do it six months? Is that sort of almost standard protocol, that that's generally what you run it on?

THOMAS: You know, it depends on the type of vaccine. It depends on the dosing schedule of the vaccine may be. Some vaccines, you need one dose. Some you need two. Some you need three. But there's always typically an early time point and then you want to look at a later time point.

VAN SUSTEREN: I take it the three who have placebos don't know this is done blindly for them? Right? You know but they don't know.

REMICH: No, the investigators are also blinded. Everyone is blind.

VAN SUSTEREN: Everyone's blind. Are you blind? Do you know who it is?

REMICH: No. We have a few select people that are unblinded that don't interact with the investigative team. But otherwise, both the investigators and subjects are blinded as to what they receive.

VAN SUSTEREN: Side effects of this? They have a sore arm? Is it an injection, by the way?

REMICH: It is an injection. It's a live virus. So we would expect side effects similar to other live viruses, like yellow fever, so mild fever, headache, muscle soreness and injection-site soreness, those kinds of things.

VAN SUSTEREN: You said live virus. I thought this was not an Ebola virus, but a gene.

REMICH: It is a visticular stomatitis (ph) virus. It replicates, but a small portion of that virus has been taken out and the Ebola gene has been inserted. So when it replicates, it will put a protein around the visticular stomatitis virus and trick the body into thinking it's infected with Ebola.

VAN SUSTEREN: How is this different than some of the other studies? There's a study being done at NIH, is there not?

THOMAS: The construct of the vaccine is different. So this vaccine combines two ingredients, and their vaccine combines one different ingredient with the Ebola-like protein. So it's really the construct is different. But the methodology of testing and the safety of plans put in place and the types of immune responses that we measure are similar.

VAN SUSTEREN: Now, I was warned do not touch anything in this lab.


I can barely move my hands away from my body we've been warned so much.

If I were to touch this -- I know that all three of you said you wouldn't be afraid to do this. But if it were spilled and I put my hand in it, what happens? Nothing or something?


REGULES: So -- so --

VAN SUSTEREN: And you laugh, but --


REGULES: We would not like you to put your hand into it but --


VAN SUSTEREN: Don't worry. I'm not touching it. I've been warned. Like I said, I'm not going to move my arms from my body at this point.

REGULES: So, again, the focus is on -- given that the focus is safety, and we don't know entirely -- can't be entirely sure what the exact safety profile is, we err on the side of safety. So while we think that the vaccine is very safe, the visticular stomatitis (ph) virus is typically not a pathogen that primarily infects people. And certain steps in the design have been taken to -- what we think we'll do is it will make it a little less pathogenic, a little safer. But we can't be entirely sure. So we have to treat it if it were the actual visticular stomatitis (ph) virus. And so what we do is warn people that again, they should note if they have symptoms of live virus infection. And we'll be asking them for -- if they have virus in the blood from the vaccine or in their saliva, et cetera.

VAN SUSTEREN: In the event that this is the vaccine that we're all hoping it is, how fast can you reproduce it?

REMICH: Speaking to manufacturing, we're not manufacturing. It's manufactured in Germany. But I know there's a group of individuals looking about where it would be manufactured, how fact it can be ramped up. Those, as of yet, are unknown.

VAN SUSTEREN: Unknown. But with ZMapp, the experimental drug given to Dr. Brantly, we don't have any right now and it takes a while to get it, which is rather alarming. Is this something that we can speed up -- I realize that's different than a vaccine, but can we speed this up faster? I mean, are we talking years, or weeks or months to mass produce this?

REMICH: I don't think we're talking years but there are procedures in place to manufacture in a very specific way to make sure it's very safe and pure and accurate in terms of the dosing. So those things take time. And the procedures have to be followed and can't be compromised.