The trial, Vaccine Against Lyme for Outdoor Recreationists (VALOR) will investigate the efficacy, safety, and immunogenicity of the investigational Lyme disease vaccine candidate, VLA15. “We are extremely pleased to reach this important milestone in the development of VLA15. Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere,” said Juan Carlos Jaramillo, MD, chief medical officer of Valneva, in a release. “We look forward to further investigating the VLA15 candidate in phase 3, which will take us a step closer to potentially bringing this vaccine to both adults and children who would benefit from it.” “I think it’s great that we’re getting a new vaccine for Lyme disease — I think it’s important that we have one, especially in environments where there are lots of opportunities to get a tick bite that can transmit the disease,” says Mark Soloski, PhD, professor (emeritus) of molecular microbiology and immunology at the Johns Hopkins School of Medicine in Baltimore, who has conducted research on Lyme disease. “The data from the phase 1 and 2 trials is promising,” he adds.
New Lyme Disease Vaccine ‘A Long Time Coming’
If the Phase 3 trial is successful and the vaccine is approved, it will be the only Lyme disease vaccine available for humans in the United States. However, that process will take a few more years, according to the companies — there aren’t plans to seek authorization for the vaccine until 2025. A new vaccine for Lyme disease “has been a while coming,” says Dr. Soloski. “We did have a vaccine back in the 1990s that was taken off the market. That vaccine, called LYMERix, was withdrawn 20 years ago due to some adverse reactions that were reported, including arthritis, which some believed was caused by specific segments of the vaccine protein, according to the National Institute of Allergy and Infectious Diseases. Although an analysis by the U.S. Food and Drug administration didn’t find evidence to support these reports, sales of the vaccine tumbled, and the manufacturer chose to stop making it.
New Vaccine Engineered to Reduce Potential Side Effects
This new vaccine has a similar mechanism of action to that discontinued vaccine; it also targets the OspA, the outer surface protein of the Borrelia bacteria that causes Lyme disease. This inhibits the bacterium’s ability to leave the tick and infect humans. But the new vaccine has been engineered differently, says Soloski. “The part of the protein that was thought to be drive significant side effects like promoting arthritis or other kinds of musculoskeletal illnesses has been taken out,” he says.
Incidence of Lyme Disease Has Nearly Doubled Over the Last 3 Decades
Lyme disease is the most common vector-borne illness in the United States, effecting an estimated 476,000 people in the United States, per the Centers for Disease Control and Prevention (CDC), and 130,000 people in Europe, according to research. The incidence of Lyme disease has nearly doubled in the last 30 years, a trend that the U.S. Environmental Protection Agency (EPA) links to climate change. The disease is caused by the bacteria Borrelia burgdorferi and, rarely, Borrelia mayonii, which is transmitted to humans through the bite of infected blacklegged ticks, according to the CDC. Symptoms can include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. Lyme disease is diagnosed based on symptoms, physical findings and the whether or not tick exposure might have occurred; lab testing is helpful if used correctly and performed with validated methods. If diagnosed early, most cases of Lyme disease can be treated successfully with a few weeks of antibiotics. If left untreated, infection can spread to joints, the heart, and the nervous system.
Nearly 6,000 People Expected to Enroll in New Trial
The randomized, placebo-controlled, phase 3 trial plans to enroll approximately 6,000 participants age 5 or older. The study is being conducted at up to 50 different sites located in areas where Lyme disease is very prevalent, including Finland, Germany, the Netherlands, Poland, Sweden and some states in the United States. Participants will receive three doses of the vaccine or a saline placebo as a primary vaccination series followed by one booster dose of VLA15 or saline placebo. Investigators will follow the participants to see if the vaccine safely stimulates immunity in any natural occurrence of Lyme disease. “If approved, the vaccine will be voluntary — it will be someone’s personal choice,” says Soloski. People who may choose to be vaccinated against Lyme disease might include those who live in New England, or states like Maryland, or people who spend time outdoors working construction, gardening, farmers, as well as people who do a lot of hiking or camping, he says. The CDC offers information on its website to help determine your risk.
An Estimated 10 to 15 Percent of People With Lyme Disease Have Symptoms That Persist After Treatment
Some people with Lyme disease often return to health after being diagnosed and treated, while others still have persistent symptoms, says Soloski. “It can be really debilitating; this vaccine will really benefit those folks,” he says. It’s estimated that about 10 to 15 percent of people who have Lyme disease have “post-treatment Lyme disease (PTLD), according to John Hopkins Medicine. “These individuals can have cognitive issues, sleep issues, vision issues, brain fog, pain and fatigue. If we can stop the infection from occurring at all, that would be a really good thing — then you won’t be one of these individuals,” says Soloski.
Other Potential Vaccines and Prevention Tools for Lyme Disease in the Pipeline
In addition to the Pfizer-Valneva vaccine, there are other potential therapies and vaccines in the pipeline designed to protect people against Lyme disease, says Soloski. “There’s a company, MassBiologics, which has developed a monoclonal antibody that can prevent a tick bite from transmitting the bacteria that causes Lyme disease,” he says. That shot may be available as early as 2024, according to a UMass Chan Medical School release. Another vaccine that is still in the early experimental phase is working on a vaccine that would immunize people against any tick bite — not just the blacklegged ticks, says Soloski. “That’s important because that vaccine would not only protect against Lyme disease but many other tickborne diseases as well,” he says.
