Can Lyme Disease be Stopped with a Vaccine for Mice?

Revolutionizing Lyme Disease Control with LymeShield

In a recent conversation with Chris Przybyszewski, president of U.S. Biologic, we talked about their innovative approach to controlling Lyme disease. U.S. Biologic is a biotechnology company based in Memphis, Tennessee, focusing on preventing endemic infectious diseases, particularly those transmitted by ticks.

Lyme disease is the most prevalent vector-borne disease in the United States, affecting around half a million Americans annually. The disease, transmitted via ticks, can lead to severe long-term health issues, including neurological, arthritic, and cognitive problems, and can even be fatal.

What is LymeShield?

U.S. Biologic has developed a unique method to tackle this issue, not by targeting the ticks, but the mice that often serve as the primary carriers of the Lyme disease bacteria, Borrelia burgdorferi. The company has created the LymeShield System, which is an integrated tick management approach that uses currently available tick control technologies and novel pellets that inoculate mice against Lyme disease, as well as the LymeShield Station, which is a timed application station that distributes pellets. The theory is simple yet powerful: if the mice are immune, they cannot transmit the bacteria to ticks, which, in turn, cannot infect humans.

How does the LymeShield System work?

LymeShield is designed to be distributed in areas with high concentrations of mice, ticks, and human activity—typically suburban backyards. The pellets are placed in specially designed LymeShield stations as part of an integrated tick management system that includes regular tick control practices and education on personal protection against ticks.

The pellets in the LymeShield stations contain a dead protein that, when consumed by mice, prompts their immune systems to produce antibodies against Borrelia, the Lyme disease bacteria. This approach is non-lethal to the mice and the ticks but effectively breaks the cycle of infection.

How effective is it?

The deployment of LymeShield Stations and pellets have undergone rigorous testing, including field trials showing a 76% reduction in tick infection rates. These studies are crucial for obtaining regulatory approvals, ensuring the method's safety, effectiveness, and ecological compatibility.

This initiative represents a significant step forward in vector-borne disease prevention, emphasizing ecological balance and targeted intervention rather than broad-spectrum pesticides or rodenticides. As Lyme disease continues to affect large populations, innovative solutions like LymeShield could be crucial in managing and eventually reducing the incidence of this debilitating disease.

Additional Information

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Transcript of the Interview

Hi, this is Mary and I am here today with Chris Przybyszewski from U. S. Biologic. Chris, welcome. Thank you so much.

Great to be here. Great. So I think start, can you just introduce yourself? Tell us tell us about yourself and and what you're up to. Sure. Yeah, my name is Chris. I'm the president of U. S. Biologic Inc. We are a biotechnology company located in Memphis, Tennessee at the University of Tennessee Health Science Center campus.

And we are a company that focuses on pandemic and endemic infectious diseases. And among those, we really do focus in on vector borne diseases. And primary among those is ticks and Lyme disease. Lyme disease is, as you're well aware, is the number one vector borne disease in the world. disease in the country, about a half a million people in the U. S. alone every year. It can cause really terrible long term health problems, neurologic, arthritic, cognitive, it can even be fatal in some cases. And so we're taking a little bit different approach. We We understand everybody understands ticks give us Lyme disease, but in most cases, people don't understand that ticks are actually infected by feeding on already infected mice in the wild in your backyard, mostly, and it's that tick and mouse interchange exchange of the Borrelia burgdorferi, which is bacteria that causes Lyme disease.

That's where we focus. And so our first product. Is a pellet that actually inoculates the mouse against Lyme disease. It's a pellet that inoculates the mouse against Lyme disease. And the simple idea is that if a mouse is not infected, it cannot pass that infection to a feeding tick.

And then if a tick's not infected, tick can't later infect another animal, including humans. And we put it into areas that are there's the most mice, the most ticks and the most humans. Usually it means about an acre and half acre basis. And it means in people's backyards. Yeah. Through different mechanisms that we can talk about.

And then we work with our partners in the pest management field. They are the ones there are licensed technicians who are trained on the application of this product. And final point is the product is licensed by the USDA and then also Conditionally licensed by the USDA and then also permitted in each of the states where we are right now.

Okay, so basically, okay So from what i'm understanding These pellets are distributed, is it mostly homes right now, or is it also commercially, like in parks or that type of thing? Sure, yeah, right now, there's an application through what we call the LymeShield Station. We put this into the context of integrated tick management.

So there's a LymeShield system that includes the Time Application Station, The pellets that inoculate the mice, and then also all of the standard tick control programs. We want people to control for ticks. We want people to control for red, for rodents. We want deer exclusion. We want to have people still doing tick checks.

We still want people to have education and doing all those things, personal protection, everything that they do. It's essential. We're adding in this new layer where these stations have a small number of pellets, and they only make about 100 pellets available every 2 weeks over the course of a 3 month period.

It's a very small amount. This station really does exclude anything except the smallest of the creatures, the mice, the 1 or 2 other small mammals might be able to find their way in there, and that allows the pest management professional to refill it 4 times a year. And so you get a year round distribution of these pellets.

The mice are feeding on it all year round even in the snow and the rain. And, it's a really great system that does its best to protect the pellets across that time. Okay. Okay. And I I sidetracked you there too. So basically, so these pellets are out there the mice come and eat the pellet.

And what is in the pellet, basically like It doesn't allow the burgdorier, I can't say it, the Borrelia burgdorferi to basically grow within the mouse. Yeah, that's right. Absolutely. It's a simple dead protein is what it is. And it causes and that's important. This isn't something like a virus.

This isn't something like a live bacteria. There's no living aspect of this pellet. It's a dead protein. That when it gets inside of the mouse's intestines, it tells the mouse's body to create antibodies against Borrelia. And just, that's it. So it acts just the same way as any other technology like it.

And it just stimulates the mouse's body to create these antibodies. are then inoculated against Lyme disease as it were. Also, there are no active ingredients. There are no chemicals here. There are no poisons in this. We're not killing the mice. We're not killing the ticks. This is something where it's a very different process.

And it works very naturally with what the mouse's system does already. No, it's just to make a side track. It's interesting. I was talking to someone recently about malaria and they're doing a study in Uganda. Basically, they're putting in for children, they're giving them these like long term, these chemo preventions that will basically, it's it keeps them from not getting malaria, even if they're bit by a mosquito that So they found if they can reduce the amount of kids that have malaria, it reduces like the whole, everyone having malaria, because then there's less ticks, there's less mosquitoes that are, that can pass malaria.

So it's a similar, like the less ticks there are in the whole community that are carrying these diseases. Parasites than less people that are bit or people are bit by a tick. It's a tick that's not, that's the whole key. It's being bit. If you are bit by a tick, you want a tick that does not carrying these germs.

Yeah. All ticks are dangerous, right? They're awful. I but what we're able to do is reduce the number of disease reservoirs, the mice. So they're called the disease reservoir because they don't have Borrelia doesn't matter to them. They don't get sick with Lyme disease. They don't have symptoms of Lyme disease like humans do.

But they do carry the bacteria. So we're reducing the number of those infected mice which means that we're going to, our field trials show a 76 percent drop in infected ticks 76 percent drop. And so those ticks are feeding on those mice that have been inoculated.

They're not getting infected. And there's your impact overall, but really it is the focus on the mouse. We are, you're inoculating those mice against Lyme disease. Now, yeah, it's such an interesting new way. So actually, I was going to ask about the study. So obviously to get any approvals like you've done, like we know for EPA, you have to prove and show a lot of data and do a lot of testing and you have to be able to do it over and over like any scientific thing.

So what did you, when you, this was developed how did that come about? Were you. Did you have the pellets? Did you have other ways to do it? Was it always let's get this pellet system? How did it evolve to this? It's been an evolution. The original inventors were Maria Gomsielecki and Luciana Richer and Maria Gomsielecki they're both veterinarians and both microbiologists.

Maria is an associate professor at the university of Tennessee. And Luciana is our laboratory director and one of our principal scientists. And over the course of several years they created in the laboratory this edible form of a vaccine that showed to be, substantially, protect these mice against the infection of Lyme disease.

And then they performed a five year field trial with the Cary Institute of Ecosystem Studies. In Millbrook, New York. And this is where they systematically put the the baits out. And they were a little bit different form. I'll tell you about in just a second. They would put these out every night.

The mice would eat them. They would capture the mice. They would test the mice, safety check, all those kinds of things. And then they looked at it year over year and they saw a 76 percent drop in the number of infected ticks in certain fields. This was a handmade cookie. This is, they had oatmeal and they literally had to.

Do this every single night, hundreds of these every single night because it couldn't last very long, it still had to be refrigerated and all those other things. And so after that time, by the way, that was about 7 million dollars of an investment from the NIH and the CDC. So there's a major investment by those agencies.

So when we got a hold of it, then Maria. And finally, she said, look I'm, I've done what I can do on this. Now it's time to start a company. And so she helped co found along with four other folks myself and the CEO and two scientists from St. Jude Children's Hospital here in Memphis, Howard Hughes Medical Institute scholars.

And we had to do we had a really a lot of challenges. We had to create something where we could make a billion doses, have them be made incredibly cheaply and incredibly fast. And so our method was to buy pellets from Purina. Purina made for us these really non nutritive pellets. They have very little carbohydrates in them.

They're very hard, just like an acorn. They're beveled just like an acorn because mice like to hold on to it and eat from the outside in, like we'd eat an apple. And we spray coated those pellets then. With the vaccine and with some with a couple of things that would protect the pellets as it would protect the vaccine as it would go into the animals and protect it through the gut of the animals.

And that's where we saw the inoculation. So you make all those things and you make it, you say, okay, we can manufacture it now. Now we have to get, we have to see that it works in the field, right? We have to know that it actually works. And so we then partnered with the Connecticut agricultural experiment station and ran a three year trial in Redding, Connecticut people's backyards.

And that's where we showed the same 75, 76 percent drop in number of infected ticks. So it was at that time we said, now we're ready to go into the USDA licensure process. Now USDA focuses on purity potency. Efficacy and safety. Those four things. It's always the, those four things. And we had to go through a number of very rigorous laboratory trials to prove every single one of those.

For example, on the safety program, we had to inoculate just hundreds and hundreds of mice. And we had to watch them over a period of several weeks and we had to make sure there were zero adverse events. The mice were not sick. Nobody died. They didn't stop eating. They weren't hunched over.

And. Looked like they were in some sort of distress and, we had performed that full thing. We then had to do an efficacy trial where we had to really we inoculated the animals and then we tried to infect them with Lyme disease. And we really, we took a needle and we just put in an enormous amount of Borrelia into the animals.

Okay. There's far more than they would ever see in a tick. Or a number of ticks, right? We just had to see that it worked and push it as far as we could go with it and we protected 65 percent of the animals that were vaccinated, which is a good number for us in the one. And and then along with that, we did purity and potency, which basically just said it's.

Exactly what we said it was. There's no other elements in there. We had to prove that step by step, and we had to show that we could manufacture it at scale the same way every single time. So the regulatory process is very rigorous. It's very unforgiving. USDA has been great. We've been working with them every step of the way, but it's, 2012. And it's been 12 years and we got to market a handful of months ago in July of 23. So it's a thank you. Yeah. It's a process though. Yeah. We know from the EPA too, cause it's a, it was on the other side, but yeah, it's important that people, I think it's important that people understand in this world, if you're making claims like this, they have to be backed up and there's many things out there that you can't That are naturals, which I'm sure absolutely there's some that work and there's some that don't.

But what I often say to people is the one thing with anything that has a registration, like from a USDA, an EPA, or an FDA, that they had to be proven. And these claims are all backed up by science. And there might be certain things you're buying on the market and it says, a natural, no one had to, no one's checking to make sure what's in there is what the label says.

So I think that it's. It's essential. Yeah, it's absolutely essential from our perspective. It was safety first And then did it make an impact, right? Is it safe? And then does it matter? And so the safety piece we did the regulatory piece, but we really took it a couple of steps further eight years of field trials.

We never saw any adverse events. We never found any mice. We, you would trap a mouse and you check its blood and you would check the ticks on the mice and then you would let the mouse go. Because we want them back in the environment. We want them to be able to do what they're doing. We never found any dead mouse, mice because of the pellets.

We also did, and of course we never found any birds or foxes, any of the natural predators. We never found anyone that was distressed or anything. We took another step further and we put it into three dozen beagles. We wanted to really put it into them and see what would happen in an off target species, is the term.

I was going to ask you about dogs, because I would think many people would be just making sure that in their backyard, their dog is not going to happen. Oh, absolutely. Yeah, and they should have questions, and they should ask questions, and they should demand this information from anybody. Certainly us.

And we put it into these dozens of dogs, and we, again, we looked at them for a long time, and we said, how are they looking? Are there, there are so many things. Are they feeding okay? Is their stool looking okay? Do they have any other, impact like fevers or anything you would normally see and we saw it was all safe.

We saw no adverse events again. These dogs were in such good shape. We are actually allowed to get them adopted. Usually when you do a dog study and if you make them sick or distress them, you usually have to sacrifice them for humanitarian reasons. In this case, the USDA examined their veterinary reports and said, they're fine, just go ahead and give them away.

And we were able to find them all homes, which made us pretty happy. None of us wanted that. So they're out, out in the wild as it were, but those are different people's homes and stuff. So actually that is, so are these, are mice attracted to the pellets in a certain way? Is there concern that like a fox is going to come eat all of them and before the mice get to them?

How does that work? That's a really important question. And there is no attractant on these pellets. There's no meat smell. There's no fish smell. There's no sugar smell. There's really nothing. And the mice are, they really do a great job of consumption. So we did a study where we went down to the field and we put the pellets out there and we put a biomarker on it and then we trapped the mice around it.

And what we found were in the stations, about 80 percent of the mice in that immediate area ate the pellets within 48 hours. So those mice went out there and they found those pellets over and over again, and they consumed those pellets at a really high rate. And when you did a simple broadcast where you would broadcast the pellets freely out into the field, 90 percent of the mice found it.

So they actually found it better when you were just randomly, broadcasting it out and the station we found we found raccoons were an interesting thing. And so one of the earlier versions of this, the station itself it allowed the raccoons to get on their side and reach under the the station.

We have nighttime cameras that were showing that. So we built new the new, the next version of the station actually has raccoon guards in it. So the raccoons can't get into it. Now, don't get me wrong. A raccoon could shred it. Okay. They can try to metal trap if they want to, but there's no meat smell in here.

There's no fish smell in here. They don't care that much to spend that much energy. They know the pellets are in there. It's just easier to go to a garbage can, or something of that nature for them. And so that's why we have very little animal. And the stations themselves are actually on a 20 pound paver stone.

So it's not like a dog can't nose it up, okay, that's what we saw earlier when we had just stakes in the ground, the dogs would get under it and push it up, and so we got a lot of stations that were at 45 degree angles. And so that's when we started putting more paper stones. So now the dogs cannot interfere with them either.

And so it's really does limit the types of critters that can get in there and get to those pellets. Oh, it's great. And I think one thing is mice. I think mice are important in our ecosystem. It's funny. I asked another Lyme expert one day and I said, are ticks important in our ecosystem? He was like, no, I haven't met anybody who can tell me.

And even that's where some of his mosquitoes too, because mosquitoes do have a place because other, like maybe other, They get eaten and so they're a food source, ticks seem to have no purpose anymore. Maybe they did at some point, but I think it's important because you, we do need mice to control other, within, especially in our backyards, we're all getting closer to nature.

We don't want to just eliminate mice cause then other things would take over. And that's, you're right. And people ask me a lot. Why don't you just kill the mice? If you have a pellet that so many mice can get to just put a poison on it. And the answer is actually really simple because it won't matter because other mice will enter that territory.

Mice are territorial. They're just like a lion. They have their area that they defend, and it's not about it. We counted on an acre by acre basis. Obviously mouse doesn't care what acre is but we counted on an acre by acre basis. And we know there are about 20 mice in that acre.

In general, it'll be anywhere between five and 20 mice in that area. And if you killed all the mice, new mice will come in. So what we do instead is inoculate those mice in that area, have them passing out those antibodies to everybody, all the ticks have them running around generating those antibodies.

We're basically making little mobile biomanufacturing facilities for the antibodies against Borrelia burgdorferi. And we want them then to maintain that ecosystem because that's where you're going to get, that, that effect you were talking about where the less infected, animals you have, the less infection spread you have, which just makes sense.

Okay, almost wrapping up, but have you, what happens when the mice have babies? Is there any pass along? Yeah, so we don't have any claim on that. We only talk about inoculating mice with our pellets. Now what we have seen in the literature though, with other people using a Lyme vaccine in different ways what they did was they inoculated the the female mice.

They were able to impregnate those mice and those mice had pups. And they did see that the pups had raised antibody levels against Borrelia and could be protected for a short amount of time. So we have seen that. Again, that's not our pellet. We don't make claims on that. But when you look at the scientific literature, that has been observed in the field.

And that's cool. That's really neat. Because again, you're, Maternal antibodies are not a new thing. We've known about these for a long time. They're enormously important across multiple species for birth rates and being able to have survival rates. But at the same time we have seen that impact here.

So it's a cool mechanism. No it's, yeah. Do you think about yet what it could do long term and, as the years and how it could just, The more it can really dramatically reduce the amount of ticks that are carrying the germs and just how the whole, the snowball effect to people and health.

And no it's really cool. So what how do people, what, if someone wanted to use the pellets, get their yard, because again, like an insect shield, we believe that it's, there's many parts to the world of protecting yourself and your family from ticks. We love that this is a new way people can protect themselves.

And especially in their own space. And I think people often forget about their own yards. They're thinking, Oh, only when I'm going on the trail, I'm going on the hike. I have to worry about ticks. Actually I think yards are high up there for people being bitten and getting potential diseases.

Yeah, absolutely. Lymeshield. com, yeah, Lymeshield. com, L Y M E Shield. com. And you'll see some more information about it and you'll see all the pretty pictures. And then when you scroll down, you'll see a contact form at the bottom. And if you reach out to us we will get you in touch with a local pest management professional who's been trained and who is certified to, sell and apply these.

And that's really the only way right now to do that. That's the, The licensure process, this is a licensed product for that, like any other pest management. And so we'll set you up in those states where, we currently have permits. And we'll let you know if that's the case. Okay, excellent.

And we'll put a link to that at the bottom of the interview. And my last question Is there a myth about ticks that you would like to debunk for us here today? Deer. It's really about the deer. I think a lot of people, the majority of people I've met over the years they believe that deer are the main purveyors of Lyme disease to the mice.

I'm sorry, to the ticks. And so they ask, why don't you just inoculate the deer? The reality is that deer, the major role of the deer is where the tips propagate. That's where they go up and they made, they lay the eggs and the next generation is born. And then as larval ticks. As baby ticks, they fall to the ground and that's where they found a mice, a mouse that's infected.

And that's when they get infected. So the deer are very important for the number of ticks that we have. And we have exploding population of deer. You're now having an exploding population of ticks, right? That's just to be expected, but they're not the source of that infection. Really, they're not it's going to be about the mice predominantly about 90 percent of the time.

There are some other squirrels or birds, that sort of thing. And but in the Northeast and the Midwest where Lyme disease really happens in the U. S. That's what the animal is that mouse. Over in California, where they do have Different. They do have different species, but even then it's a peromyscus leucopus, the white footed mouse, or it's the the, one of the rats that they have out there.

Yeah, but the deer all about the number of ticks, but it's the mouse about the infection. Okay. And I do have one more question. I just thought of, are you all potentially working on this for other tick borne? Diseases and germs. Yeah. Yeah. That is a great question because yeah, ticks pass over a lot of diseases, right?

We do have Lyme is the most prevalent but there's Babesiosis, there's Anaplasmosis, there's Alpha Gal, all these different pieces. Our solution to that is actually an anti tick vaccine. That we're working on. This will go right alongside Lyme vaccine, and this actually will reduce the number of ticks by making it more difficult for those ticks to reproduce.

And so we're working on that in the laboratory right now. We'll be entering field trials soon. And we're going to roll that out and talk about that more as we get make more progress. It's very exciting. Yeah. This is, no, it's so cool. And it's really interesting to, you're coming at it from such a different side, which is wonderful because, there's a lot of the repellent world and just protecting yourself and your family, but to say, okay, how do we, it's the animals that it's all starts from.

Let's go to the beginning and get that see what you can do there. So it's really cool. And just, we're thrilled to tell what you guys are up to and we'll keep an eye and and I appreciate that. If we want to get serious about infectious diseases, we got to go to this horse.

Really, we have to have, we have to have diagnostics for humans and treatments and, vaccines for humans, like absolutely. But we, if we're actually going to be serious about it, this is a harsh statement to say, cause it makes it sound like we haven't been serious, but if we're actually going to be serious about it, we got to go to the animal source and that's where we are.

And we're spreading the good word along with these pellets that inoculate mice against Lyme. Okay. Wonderful. Thank you so much for for joining me today and we'll be we'll be watching you. Thanks. I appreciate you so much. Okay. Have a great day. Take care. Thank you.