The COVID-19 vaccine trial Texas A&M Health is leading

scientist working with a vaccine in a laboratory
More episodes in the The Vantage Point Podcast

Researchers at Texas A&M Health are leading a phase 4 clinical trial to find out if an existing tuberculosis vaccine, BCG, can protect against COVID-19 illness.

Episode Transcript

Mentioned links

Sign up for the BCG vaccine trial for COVID-19.

Read the article about the trial that Kevin references.

Show transcript

Lindsey Hendrix: We sit down with experts who are tackling some of the most pressing health issues. From the opioid crisis to hospital closures, food desserts to human trafficking, these are the problems that impact us all. Find out how Texas A&M is contributing solutions. You’re listening to The Vantage Point on Texas A&M Health Talk.

Howdy, friends. Lindsey Hendrix here, recording from my home office. Here at Texas A&M, we are practicing safe social distancing, working from home as much as we can, so I’m not in the studio. I apologize that the audio is not quite what you’re used to, but we’re all doing the best that we can. I truly hope that you guys are staying safe. I’ve missed you, and I’m really happy to be back on the air for this special episode of The Vantage Point.

Today, we’re featuring a special show from our friends at CHI St. Joseph Health. The following conversation about a potential vaccine to protect against COVID-19 was recorded for their Inside Health Podcast. So, if you’re interested in getting more content from them, go subscribe to the Inside Health Podcast wherever you get your podcasts. In this episode, they talk with our own Dr. Gabe Neal about a late-stage, phase four clinical trial Texas A&M Health is leading to find out if an existing tuberculosis vaccine can be effective in mitigating severe illness from COVID-19.

If they’re successful, this vaccine could provide a level of protection for health care workers, essential personnel and perhaps even the general public until a COVID-19 vaccine is widely available. Just a quick note about this vaccine trial before we get into the episode, the researchers are actively recruiting health care workers to volunteer. So if you’re interested in stepping up to the plate, please visit health.tamu.edu/bcgtrial. Again, that’s health.tamu.edu/bcgtrial. I’ll be sure to provide a link to that website in the show notes. Now, without further ado, the show. Enjoy.

Kevin Keys: Welcome back to the Inside Health Podcast. I am your host, Kevin Keys.

COVID-19 has forced us to make more consistent changes in our daily health habits and that’s probably a good thing. We’re washing our hands more frequently. We’re covering our coughs and sneezes, and doing our part to try to slow the spread of this virus. But there’s one thing that our society will really need to knock out COVID-19, and that of course is an effective and safe vaccine. I’m a big supporter of vaccines, so when I heard that there’s research being done on one for COVID-19 in my backyard at Texas A&M University, and it’s in a late-stage, phase four clinical trials, I was very excited to talk to someone about it.

Today, we are blessed with not only one, but two, very special guests talking about the research that is happening at Texas A&M on this vaccine. That, of course, is Dr. Kia Parsi and Dr. Gabriel Neal. Dr. Parsi earned his doctor of medicine degree at Baylor College of Medicine in Houston, and is a member of the American Board of Family Practice, American Geriatric Society, and the Texas Medical Association. Dr. Parsi was a member of the CHI St. Joseph Health Medical Group for 18 years, serving as medical director for the Caldwell Family Medicine Center, chairman of the board of directors for both CHI St. Joseph Health’s clinically integrated network and accountable care organization, and medical director for the Senior Service Line. Currently, Dr. Kia Parsi is the chief medical officer and family medicine physician for CHI St. Joseph Health.

Dr. Neal is board certified in family medicine and received his medical degree from the University of Oklahoma. He became a clinical associate professor at Texas A&M in the Department of Primary Care and Population Health, and is also a faculty member in the Texas A&M Family Medicine Residency. Over the past decade, he has taught numerous preclinical and clinical courses for the College of Medicine. He is the family medicine clerkship director for the A&M Integrated Medicine Program at the Bryan-College Station College of Medicine campus. He was awarded Clinical Faculty Preceptor of the Year in 2011, and often writes lectures and interviews for lay audiences regarding popular medical topics. Dr. Neal is also currently the director of Texas A&M Family Care, formerly Texas A&M Physicians Clinic. Dr. Parsi, welcome to the podcast.

Dr. Kia Parsi: Thank you for having me. I’m excited to have this discussion.

Kevin Keys: Yeah, it should be good. Dr. Neal, welcome.

Dr. Gabriel Neal: Thank you very much. It’s great to be here.

Kevin Keys: Yes. Thank you both for being here. This is very exciting. I’m excited for this topic. So, one of my favorite things to do though to start off the podcast is a little icebreaker question, something a little bit fun and also topical. Have you guys seen the news about murder hornets and making their way to the United States?

Dr. Kia Parsi: Well, it’s funny. I think I got a text message about hornets invading or attacking a squirrel, but I did not open it. So I am not fully knowledgeable about that. I might need to learn more.

Kevin Keys: Dr. Neal?

Dr. Gabriel Neal: Yeah. I saw a newsfeed on it. Apparently they’re in Washington state now. My wife asked me about it because it came up on one of her newsfeeds too. It sounds horrible, whatever it is.

Dr. Kia Parsi: Yeah, yeah. Wasps in general I try to stay away from. But killer wasps?

Kevin Keys: Do you think that murder hornet honey is better than regular honey?

Dr. Gabriel Neal: Maybe it has some spice to it, little sting.

Kevin Keys: Spicy honey? Okay. So we’ll go ahead and get started. The one thing that I keep hearing when talking with physicians is that mass vaccinations is needed to beat COVID-19. So why is that? Why is a vaccine important for our community and our health care workers?

Dr. Kia Parsi: I can just respond to that and I’m sure Dr. Neal can add as well. Vaccinations have been one of the greatest scientific and medical advances that we have seen over the last few hundred years. Vaccines can almost completely eradicate a certain illness or disease. And when we see the challenges that we are facing with COVID-19 with this new coronavirus, having a vaccine that can create immunity without any risk of illness, that is golden. So over the last 50 years, we’ve seen eradication of polio for the most part. Smallpox, other very common illnesses. By creating a vaccine, we have decreased the death and illness rate of these diseases. We would like to do the same with COVID-19.

Kevin Keys: Yeah, that’s great. And could you go into a little bit more detail on why it might be important? Obviously it’s important for our community, as you described how vaccines have been life-saving in general. But can you go into how they’re important for our health care workers as well?

Dr. Gabriel Neal: Well, health care workers are among the highest risk individuals for catching this disease, COVID-19, because of the exposure. We have health care workers right now in our hospital that are treating COVID-19 positive patients daily, and we want them to work in an environment where they feel it’s safe to work and not have that undue burden of catching the disease or passing it on to their family members.

Kevin Keys: Yes. One of the things that I get to do in this awesome position that I have here is, I get to sit down and talk with a lot of medical professionals. And one of them that I spoke to was the chief medical officer at St. Luke’s, Dr. Raza. And he was talking a little bit about comparing this to SARS. And he said that in 2003, SARS fizzled out before a vaccine could be developed. What’s different here, besides the obvious that COVID-19 has hasn’t fizzled out yet?

Dr. Kia Parsi: It’s great that you have Dr. Neal on the line because he actually dealt with, I don’t know if it was SARS, but didn’t you deal with MERS, Dr. Neal?

Dr. Gabriel Neal: That’s true. I was living in the United Arab Emirates during the 2013, 2014, 2015 years, where MERS was present. And I was unfortunate enough to live really in the epicenter, the town of Al Ain, where most of the cases were occurring in the Emirate of Abu Dhabi. So the World Health Organization would generally report the cases from Abu Dhabi, but they were truly in our town. And, one of the real keys to surviving that coronavirus infection was wearing masks, which we’ve emphasized during this pandemic here with the SARS-CoV-2 pandemic, and wearing gloves. And what we found there was that if doctors and nurses were wearing appropriate masks and gloves, then they didn’t die. And then if they didn’t, then they did. And so, it was an interesting time to be in the Middle East and to experience that.

This virus though seems different. I was hoping that it would be as quick to go away as MERS was, thankfully not as deadly as MERS was. But, this one seems to be lingering and I’m happy to talk further about it, but it has some characteristics to it that make it different from SARS and MERS in particular.

Kevin Keys: Yeah. Curious myself, what are some of the different characteristics there?

Dr. Kia Parsi: Well, Gabe, you can probably add as well. There’s a couple of characteristics, they’re all coronaviruses, but with this virus, it seems to be more infectious, so people catch it easier. So there’s an infectivity rate. So if you’re infected, what is the likelihood of you infecting those around you? It seems to be higher with this one.

Another characteristic is, there seems to be a asymptomatic phase, where you could have the disease, be contagious, and not know it. So you’re more likely to spread it to other people because you don’t have any symptoms. And you’re still in the workplace. You’re still among your family and friends. And that seems to be one of the bigger challenges with this virus.

Dr. Gabriel Neal: Yeah. I’ll add to that. The amount of time that this COVID-19 virus spends hiding but being transmitted before you were aware of it, is longer than with the MERS and the SARS. And then people are experiencing the illness longer than with the MERS and the SARS. I remember the MERS virus, people would get it, and they would die within days. There was not a period of weeks where they were ill in the hospital, then maybe got better. And then they got really bad and then died. This one seems to really take a long time to do what it’s going to do to somebody. And that makes it really hard to slow down.

Kevin Keys: So, okay. In general, what is the progress in vaccine development for this virus? How many other trials are maybe going on in the world right now?

Dr. Kia Parsi: I don’t know the exact number, but I know that there’s a lot of work, and it’s global. Not just in the United States, but around the world. I know England has a trials at Oxford that they’re working on. One of the challenges we’re facing now is, usually to get a vaccine through development and be ready to be utilized takes years.

Dr. Gabriel Neal: Right. I’ll add to that. I’ve seen certain organizations who are counting how many trials there are for therapy and for vaccinations, and there’s over a hundred different vaccine trials, and an almost 200 or more than 200 therapeutic trials currently. So there’s hundreds of vaccine and therapeutic trials that are currently in progress right now. But there is consensus that for a COVID-19 or a SARS-CoV-2 vaccine that’s specific to that, we are years away. The idea that we’re one year away from a vaccine is really not entirely accepted. Those of us who are taking a longer view of it, I think it’s two to three or more years away.

Kevin Keys: Right.

Dr. Kia Parsi: We’re trying to accelerate it as quickly as we can. So typically it would definitely be years. We’re not just talking one or two or three years, usually it takes multiple years to get a vaccine. I think Dr. Neal is correct that most likely it would take two or more years, although I have heard, 18 months. That might be very optimistic. It might be a hope more than a goal. But definitely the worldwide medical community is working as quickly as they can to find a safe, effective vaccine.

Kevin Keys: Right. And that brings me to my next question. Can you give a general timeline for what is required of a vaccine to go from early development to worldwide use? And I guess maybe a follow up to that is, why does it take so long?

Dr. Kia Parsi: Number one, the animal models that they generally start with, don’t always translate into benefiting humans. And so even if they come across something that seems to the effective in mammals, like mice, that often doesn’t translate into benefit in humans. And so, there’s many, many, many studies that usually occur that that are inconclusive in whether there’s benefit or not. And it takes a while to get a study that can truly indicate that there is a benefit, and that just takes time. I think that’s the easy answer for why it takes a while. It takes time to get robust data.

Well, I will say in general, first you have to have testing in the lab, and that may not even be with live animals. So there’ll be in vitro testing just in the lab setting. So that’s one stage. Then you go on to animal testing. And after that you would go to humans. And one of the challenges with therapies or vaccines is you don’t want to do harm, and so you have to have some robust data before you will ever bring it to a human being. There is always a potential that without safe standards, you can cause significant harm to the individuals in a trial.

Kevin Keys: Yeah. As I mentioned in the intro, Texas A&M is working on repurposing a vaccine that’s already in use for other treatments and has been seen to be safe for that. Can you give us some background on this vaccine?

Dr. Gabriel Neal: The BCG vaccine is used worldwide to prevent tuberculosis, and it’s been around for decades. There’s a number of different strains and different makers of this vaccine, and it’s a wonderful work that is being done worldwide with that vaccine. It’s also a therapy for bladder cancer, which was remarkable. They actually injected into tumors in bladders. So it has two very wonderful current good uses at least. And, its safety profile is very well established. Billions of doses of a BCG vaccine have been given over the past several decades. And while there are some mild side effects to the vaccine, such as developing a small scar on your arm, its benefit way outweighs a scar that you might get on your arm. And so, repurposing of vaccine that we know is very safe in humans to fight a COVID-19 helps us move much farther down the track to being able to offer health care workers, or even the general public perhaps, something that they can take to help prevent and reduce the burden of illness from COVID-19 in the future.

Kevin Keys: That’s excellent. So, why this vaccine? What made it stand out to researchers as a possible solution?

Dr. Gabriel Neal: Well over the past several decades, the vaccine has been studied in many different contexts and what they have found is that, it actually causes our body’s immune system to be more effective against a number of different viruses. And so, with this idea that it can cause not just an anti-tuberculosis immunity, but if it can improve our immunity to other diseases as well, then it could, or will likely, give us a boosted immunity towards COVID-19. So that’s the theory. We don’t know the answer to that, but since it seems to work on other viruses, it could work for COVID-19.

Kevin Keys: That’s good to hear. That’s great.

Dr. Kia Parsi: Dr. Neal covered it. Going back to your previous question, how long does it take? Well, this is a vaccine that’s already been tested and safe. So it can go to human trials right away and not go through those other phases.

Dr. Gabriel Neal: Starting tomorrow.

Dr. Kia Parsi: That quick.

Kevin Keys: That’s great. We do a podcast that starts tomorrow. So, in preparing for this and talking with both of you, I read an article from Texas A&M Today, that talks about how this vaccine—you mentioned it’s called BCG—is widely used, and I’ll make sure to link that article that I was reading in the episode description so the listeners can read it too. Is this vaccine something that we use here in the U.S., and if so, do we all receive it or is it just for a specific population?

Dr. Gabriel Neal: Well, the United States does not employ the tuberculosis vaccine on all children or adults because the incidence of tuberculosis in the United States is so low. So it is used worldwide, but not in the U.S. So if you were born and raised the United States, it’s very unlikely that you would have had this vaccine already. But if you were born in the United Arab Emirates, like my fourth child was, then they just had the BCG vaccine because they give that to every child at a certain age. So it really depends on where you grow up, whether you’ve had it or not.

Dr. Kia Parsi: My wife, she was born in Korea, South Korea. She has the scar from the vaccine. One of the reasons why, as Dr. Neal said, we don’t utilize it in the U.S. Is because of the low incidence of tuberculosis. And the way we screen for exposure to tuberculosis is a skin test. If you have the vaccine, your skin test is positive. So it affects our ability to monitor and evaluate if you’ve been exposed to tuberculosis.

Kevin Keys: Right. Right. Okay. That same article talks about how currently Texas A&M is seeking 1,800 health care workers to start testing on this vaccine, and you mentioned it might even start as early as tomorrow. So what does the landscape look like for the completion of this trial for the vaccine? And what else is needed to complete, I guess, this research?

Dr. Gabriel Neal: Well, we just need health care worker volunteers. We are partnering with a number of other institutions like Harvard and UCLA, and we need hundreds and hundreds of health care volunteers to get enough data to show that it’s effective in reducing the burden of illness from COVID-19. So right now we’re in that recruiting phase and we’re beginning to give the injections. Like I said, tomorrow’s going to be the first day of therapy with the injections, which we’re very excited about. But, it’s not nearly the 1,000, 1,800 that we need. So, we’re trying to expand our clinical sites right now to bigger cities to try and get more health workers involved. But we’re very grateful for those that have already volunteered and that have tried to sign up and are involved in the current clinical trial out here in Bryan-College Station.

Kevin Keys: One of the things I noticed that that article talked about too, and I think it might be important to mention, is that this vaccine isn’t necessarily designed to eradicate the virus, but more or less to slow things down, or to maybe reduce some of the complications that people were getting from it. And then give us a window for that continued development. Is that how this is going to work?

Dr. Gabriel Neal: Right. Something you alluded to earlier was, wanting to protect health care workers during a pandemic. I’m very happy that we have not seen the infections and death among health care workers that worst-case scenarios might’ve brought us with this pandemic. But there’s no doubt that our health care workforce has been impacted by it. But, when you look at the literature for pandemics, you have to plan for about a 40 percent attrition rate among your health care workers in a pandemic, which is a huge number. So just when your need for doctors and nurses and respiratory therapists and physical therapists and all the things that people need when they’re very ill, when you’re at your biggest need is when your health care workers will be at their most sick. And that’s a double whammy that we’d like to avoid. And so, this therapy can be a stop-gap between now and when the vaccine is developed, and it could also be a used in addition to a future vaccine to help protect health care workers. So it could serve two purposes in the future.

Dr. Kia Parsi: Yeah. And Dr. Neal could clarify, but because this is not a specific vaccine for the COVID-19 virus, we’re hopeful that it can create some immunity, but probably the likelihood of having a very vigorous immunity is less likely. So, as you mentioned, this might be a good stop-gap, but we might be wrong. It might create significant immunity that would be adequate to not have to investigate for further vaccines.

Kevin Keys: Right. Either way it’s good. It’s good stuff if it all goes over well. Okay, so how long will this trial take to see if the vaccine is effective, and I guess more importantly, safe? Assuming we get all the health care worker and volunteers pretty quickly, how long do you think that that testing process takes?

Dr. Gabriel Neal: We are tracking each participant for six months with regard to their immune status and days missed of work related to illness, particularly COVID illness. There are some aspects of the study that may continue longer, but that’s the bulk of the work that will occur within six months. So, when we enough volunteers and enough participants, really within six to 12 months, we should be able to have the data that says this is something that’s worthwhile or not.

Kevin Keys: Is there anything that people can do to help with the research? Maybe sign up once the health care community has been thoroughly tested? I’m ready to sign up now, where do I sign up?

Dr. Gabriel Neal: Yeah, there’s been a ton of non-health care worker interest in the study and it’s been hard to exclude non-health care workers from participating in the study. But we want the study to be rigorous, and so we have to be very judicious about our selection process. So I really appreciate how there’s a ton of excitement from people who aren’t involved in the health care world for getting this, because everyone could potentially benefit from it. But at the moment, you could ask your own doctor, “Hey, have you signed up for the vaccine trial?” That could be useful.

Kevin Keys: I’ll do that. Okay, I’ll give him a call right now. All right, I like to finish the episode the way that we started with a little bit of fun. So this time we’re going to play a little bit of Jeopardy. So you have to write down your answers and wager the fake money to see who’s the winner. So are you guys ready for that?

Dr. Kia Parsi: Let me get a pen here real quick. I already forfeit to Dr. Neal. Okay. I’m ready.

Kevin Keys: Okay. I like hockey, ice hockey. So the category is ice hockey. We’re going to test your ice hockey knowledge all the way down here in South Texas.

Dr. Gabriel Neal: Oh geez.

Dr. Kia Parsi: My wagering is very little on this.

Kevin Keys: So, the answer is, “The last team to win the Stanley Cup in two consecutive seasons.”

Dr. Gabriel Neal: Oh gosh.

Kevin Keys: Give you a little bit of time. I’m not going to do the theme song.

Dr. Gabriel Neal: Okay. I have an answer, but I have …

Dr. Kia Parsi: Trying to remember the …

Dr. Gabriel Neal: … Okay.

Dr. Kia Parsi: … I know the city. I’m just …

Kevin Keys: If you know the city, I’ll give you half of whatever your wager was.

Dr. Gabriel Neal: I don’t know the city. I’m completely guessing.

Dr. Kia Parsi: Oh, I remember. I remember. I remember. It just came to me.

Kevin Keys: Okay. All right.

Dr. Kia Parsi: All right. All right. Okay. All right.

Kevin Keys: Okay. All right. All right. And one, two, three, all right. Dr. Neal says, “Who is the Detroit Red Wings for $5?” Dr. Parsi?

Dr. Kia Parsi: I said for $3, who are the Edmonton Oilers?

Kevin Keys: Well, both of those teams did win Stanley Cups. The Oilers did it twice in the ’80s, and the Red Wings did it in ’97 and ’98. But the last team to win, it was actually the Pittsburgh Penguins in 2016 and 2017. So you both had winning teams, but not the most recent.

Dr. Gabriel Neal: Gosh.

Kevin Keys: So no, I like to have a little bit of fun. And, I appreciate you guys coming down here to do this so much. Dr. Parsi, Dr. Neal, thank you for taking the time to do this today. The work that you guys are putting into this vaccine is really good news, especially during a difficult time for many of us. We all appreciate the work that you guys are doing, and we appreciate all of the health care workers brave enough to be on the front lines right now and to sign up for this vaccine research. Is there anything else that either of you guys would like to say about any of this?

Dr. Kia Parsi: Well, I just want to say I’m so excited that Dr. Neal and Texas a A&M University Health Science Center’s in this study. We need all hands on deck and CHI St. Joseph Health really wants to support this, and are looking forward to the results that they come up with.

Dr. Gabriel Neal: Right on. I want to say thanks to CHI St. Joseph for the support they’ve shown us, particularly Dr. Kia for helping us recruit. And I’m grateful to the doctors and nurses from CHI St. Joe’s who have volunteered, and will be coming tomorrow to get their shots. So, very excited.

Kevin Keys: Well, thank you guys again, and thank you listeners for tuning in. We will have more episodes coming your way, so stay tuned. And if you like the show, don’t forget to hit subscribe and leave us a review, we’d love to hear from you guys. So thanks again, and we’ll see you guys next time. Bye.

Timothy Schnettler:

Thank you for joining us on Texas A&M Health Talk, a production of the Texas A&M University Health Science Center. Visit us on the web at vitalrecord.tamhsc.edu, where you’ll find answers to all of your health questions. Until next time, stay healthy.