Does A Lyme Disease Prevention Exist?

Although a vaccine against Lyme Disease does not yet exist, Mark Klempner, Professor of Medicine and Executive Vice Chancellor for MassBiologis at the University of Massachusetts Medical School, describes work currently being conducted that may soon be available to guard you against Lyme disease infection.

I have quoted from his article, Can a seasonal shot help slow the epidemic spread by ticks? below.

Lyme disease has become an insidious epidemic in the United States. Caused by bacteria transmitted by an infected tick bite, symptoms can include arthritis, 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 around 300,000 people 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 disease-causing bacteria. However, the ticks’ range continues to expand. Today, over 50% of the American population lives in an area where these ticks are found…

My colleagues and I have been working on a different kind of prevention: a yearly injection. I am an infectious diseases physician-scientist and have been studying and working toward preventing Lyme disease for much of my career. I also oversee UMass Medical School‘s MassBiologics, 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‘s 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, including its success in mice and nonhuman primates. Later this year, we are scheduled to begin our first human phase 1 trial.

Unlike a vaccine, Lyme PrEP uses a single human antibody, or blood protein, to kill the bacteria in the tick’s 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 it proved 100% effective.

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% 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 1 clinical trial later this year is to test for the treatment‘s safety and determine how long it lasts in the bloodstream in humans.

For the phase 1 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 1 clinical trials would be completed in 2021. The phase 2 trial to test for safety and efficacy in a small group of volunteers would follow and then be followed by a phase 3 trial to test the efficacy on many volunteers. We hope to complete these larger studies in late 2022 or 2023.