Lyme disease has become an insidious epidemic in the United States. Caused by bacteria transmitted by an infected tick bite, arthritis and cardiac and neurological problems if left untreated. It is the most common tick-borne illness in the United States, and the Centers for Disease Control and Prevention estimates that likely contract the disease each year.
Scientists, doctors and ecologists have worked for decades to slow the spread of Lyme and the blacklegged, or deer, ticks that carry the . However, the ticks鈥 range continues to expand. Today, where these ticks are found.
The U.S. Food and Drug Administration approved a vaccine against Lyme in 1998, but it was met by controversy and . Efforts continue today to create a human vaccine as well as stop the spread of Lyme by other means, including using that can transmit the bacteria to ticks, and using to control ticks.
My colleagues and I have been working on a different kind of prevention: a yearly injection. I am an and have been studying and working toward preventing Lyme disease for much of my career. I also oversee , the only nonprofit, FDA-licensed manufacturer of vaccines and biologics in the United States.
Our method, known as Lyme PrEP, delivers a single anti-Lyme antibody directly to a person rather than triggering the patient鈥檚 own immune system to make many antibodies as vaccines do. It is designed to be a seasonal shot that people can get once a year before tick season begins. We have published several peer-reviewed articles on this methodology, and nonhuman primates. Later this year, we are scheduled to begin our first human Phase I trial.
A vaccine鈥檚 cautionary tale
In 1998, the FDA approved a composed of protein antigens from the surface of the Lyme bacteria, Borrelia burgdorferi.
A vaccine works by introducing proteins from the disease-causing agent into the body to trigger the body鈥檚 immune response, which includes making antibodies against bacterial proteins. Antibodies have been used to prevent and treat infectious diseases for over a century. In the case of the Lyme vaccine it can take many months for the body to build up the necessary level of immunity to prevent infection. It also means that some of the antibodies induced by the vaccine can have 鈥渙ff-target鈥 effects, or side effects.
The vaccine, known as LYMErix, largely reduced infections but was because of limitations and controversy.
It needed to be administered by multiple injections over a year before immunity developed. Uncertainty about the length of immunity from the vaccine also raised questions of whether a booster shot would be regularly needed. Further, such as arthritis, reported by some who had been vaccinated, contributed to its decline in popularity.
Today, a French biotech company, in collaboration with Pfizer, is that is currently in clinical trials.
A different approach
Unlike a vaccine, Lyme PrEP uses a single human antibody, or blood protein, to kill the bacteria in the tick鈥檚 gut while it takes its blood drink, before the bacteria can get into the human host.
Through our research, we realized that just one of the antibodies that the human body developed after multiple injections of the LymeRx vaccine was sufficient to prevent infection. So we identified which antibody led to immunity and tested it in animals where
These animal studies show Lyme PrEP gives protection immediately upon injection, as it circulates through the blood. Unlike a vaccine which induces many antibodies that may not contribute to protection but can cause side effects, this approach uses a single, defined antibody, thus reducing the risk of side effects.
Initial tests of a single injection of Lyme PrEP protected mice for several weeks.
Humans, however, need to be protected longer, likely for the nine-month season when over 90 percent of cases occur. We have developed the Lyme PrEP antibody to extend its protective effects to cover this amount of time. Yet, the actual duration of protection will have to be determined during clinical trials.
Our goal for the Phase I clinical trial later this year is to test for the treatment鈥檚 safety and determine how long it lasts in the bloodstream in humans.
For the Phase I trial we want to avoid testing the Lyme PrEP antibody on volunteers who may have already been exposed to the Lyme bacteria and have developed responses to the bacteria that could confuse the results. For that reason, initial testing will take place in volunteers who have not been exposed to Lyme disease.
If all goes well, Phase I clinical trials would be completed in 2021. The Phase II trial to test for safety and efficacy in a small group of volunteers would follow and then be followed by a Phase III trial to test the efficacy on many volunteers. We hope to complete these larger studies in late 2022 or 2023.
The COVID-19 pandemic has put in sharp focus the need to prevent infections and the old adage, 鈥淎n ounce of protection is worth a pound of cure.鈥
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