There is no Lyme disease vaccine, but annual antibody injections show promise in preventing infection

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Mark Kleppner, School of Medicine, University of Massachusetts

(Conversation) Lyme disease has become an insidious epidemic in the United States. Symptoms caused by bacteria transmitted by an infected tick bite can include arthritis, heart and nerve problems if left untreated. It is the most common tick-borne disease in the United States, and the Centers for Disease Control and Management estimates that it affects approximately 300,000 people each year.

Scientists, doctors, and ecologists have worked for decades to slow the spread of black foot or deer ticks that carry lime and disease-causing bacteria. However, the range of ticks continues to grow. Today, over 50% of the American population lives in the areas where these mites are found.

The US Food and Drug Administration approved a vaccine against Lyme in 1998, which was controversial and withdrew from the market three years later. In addition to using genetic vaccines to immunize mice that can infect ticks with bacteria, kill deer, and use insecticides to control ticks, humans are not only able to stop the spread of lime. We are also focusing on the development of vaccines.

My colleague and I have been working on another type of prevention: annual injections. I am an infectious disease doctor and scientist, and I have continued my research and research towards the prevention of Lyme disease. He also oversees Mass Biologics at UMass Medical School, the only non-profit, FDA-approved vaccine and biologics manufacturer in the United States.

Our method, known as Lyme PrEP, sends a single anti-Lime antibody directly to a person, rather than eliciting the patient’s own immune system to make as many antibodies as a vaccine does. It’s designed to be a seasonal shot that you can take once a year before the tick season begins. We have published several peer-reviewed articles on this methodology, including its success in primates other than mice and humans. Later this year, we plan to launch our first Phase I trial.

Vaccine notice

In 1998, the FDA approved a Lyme vaccine consisting of protein antigens from the surface of the Borrelia burgdorferi lime.

Vaccines work by introducing proteins from pathogenic bacteria into the body and producing antibodies to the body, such as making antibodies against bacterial proteins. Antibodies have been used to prevent and treat infections for over a century. With the lime vaccine, it can take months for the body to build the level of immunity needed to prevent infection. It also means that some antibodies elicited by the vaccine may have “off-target” effects or side effects.

The vaccine, known as LYMErix, significantly reduced infection, but withdrew from the market after three years due to restrictions and controversy.

It had to be given as multiple injections a year before the immunity developed. The uncertainty about the length of immunity to the vaccine also raises the question of whether boosters are needed regularly. In addition, advertising about side effects such as arthritis reported by vaccinated people contributed to the decline in popularity.

Today, a French biotechnology company is working with Pfizer to develop the Lyme vaccine, which is currently in clinical trials.

Another approach

Unlike vaccines, Lyme PrEP uses a single human antibody or blood protein to kill mites in the gut, while the blood is swallowed, before they enter the human host. ..

Our study found that only one of the antibodies developed by the human body after multiple injections of the LymeRx vaccine was sufficient to prevent infection. So we identified which antibodies led to immunity and tested them in animals that were 100% proven effective.

These animal studies show that Lyme PrEP circulates in the blood and thus provides protection shortly after injection. Unlike vaccines that induce many antibodies that do not contribute to protection but can cause side effects, this approach uses a single defined antibody, reducing the risk of side effects.

Initial testing with a single injection of Lyme PrEP protected mice for several weeks.

However, human protection needs to be lengthened, and over 90% of cases can occur in a 9-month season. We developed the Lyme PrEP antibody and extended its protective effect to cover this time. However, the actual duration of protection must be determined during clinical trials.

The goal of the Phase 1 clinical trial later this year is to test the safety of the treatment and determine how long it lasts in the human bloodstream.

In Phase 1 trials, try not to test Lyme PrEP antibodies in volunteers who may have already been exposed to Lyme bacteria and have shown reactions to bacteria that can confuse the results. Therefore, an initial examination will be performed on volunteers who have not been exposed to Lyme disease.

If all goes well, Phase 1 clinical trials will be completed in 2021. A Phase 2 trial testing safety and efficacy in a small group of volunteers, followed by a Phase 3 trial, testing the efficacy of many volunteers. These large studies will be completed by late 2022 or 2023.

The COVID-19 pandemic focuses on the need to prevent infections and old sayings, saying “1 ounce of protection is worth 1 pound of cure.”

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This article was republished from Conversation under the Creative Commons License. Read the original article here: https://theconversation.com/a-lyme-disease-vaccine-doesnt-exist-but-a-yearly-antibody-shot-shows-promise-at-preventing-infection- 138230.