- The Centers for Disease Control and Prevention estimates nearly 500,000 cases of Lyme disease in the US each year.
- Bites from black-legged ticks spread Borrelia burgdorferi, the bacteria that causes Lyme disease.
- In Massachusetts, tick activity peaks in March and April and in October and November, according to the Department of Public Health.
- Tick-borne illness in Massachusetts peaks in July and August, with cases reported most often in children and older adults.
Do you like the outdoors? Lyme disease vaccine researchers are looking for you.
While Pfizer and the French company Valneva work to develop a potential Lyme disease vaccine called VLA 15, they’re looking for test subjects, including in Massachusetts, who want to try it.
Care Access, a clinical trial company, recruits participants ages 5 and older, with research sites in Wareham, Rockland and Vineyard Haven, a community on Martha’s Vineyard.
An application questionnaire can be found at careaccess.com.
Participants are being sought for the third of four required phases of human trials for vaccine development.
Pfizer said the study is being conducted at as many as 50 sites in the US and Europe where Lyme disease is well established. European sites include Finland, Germany, Netherlands, Poland and Sweden.
Trial coordinators are looking for people who spend a lot of time outdoors and are therefore at greater risk of tick bites that transmit Lyme disease.
If successful, the vaccine would be the first Lyme disease vaccine on the market in more than 20 years.
Participation is free of charge. A stipend may be available, the amounts of which vary depending on location.
Here’s what you need to know about the vaccine trials, what’s fueling the spread of Lyme disease, and efforts to fight it.
What kind of people are being sought for the Lyme disease vaccine trial?
“Basically, the goal is to enroll volunteers who are healthy or stable,” says Dr. Peta-Gay Jackson Booth, a physician and principal investigator in the Care Access study. “Age and size is as old as you want to be and still be able to hang out outside.”
“We are particularly interested in the pediatric population,” Jackson Booth said.
Researchers will consider anyone who has been exposed to Lyme disease through regular outdoor activities — hunting, jogging, landscaping, soccer — who would normally come into contact with ticks, or has been bitten by ticks, or has previously been exposed to Lyme disease.
Even if they had a past [with Lyme disease,] they still need to be exposed.
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Why were the three locations in Massachusetts chosen?
Jackson Booth said, “Studies are being conducted in the northeastern US and New England, where Lyme disease is endemic.”
This means that a disease is spreading at a normal and predicted level. Other sites include communities in Connecticut, Rhode Island, Pennsylvania and Maryland.
Before any new or different vaccine can receive Food and Drug Administration approval, four phases of human trials follow animal testing. Animal testing is used to determine if it works and if it is safe to test on humans.
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Jackson Booth said, “The idea is that you could release the primary series in the spring of next year. The ticks survive the winter any time of the year, but the highest prevalence is spring to fall.”
Jackson Booth explained that the four human testing phases are:
- testing with a small group of people
- testing with a larger group
- the third phase, where the vaccine is currently, with a group of several thousand people
- the so-called open market phase, in which it is continuously monitored how well the medication is doing.
Once the data is analyzed, it will be presented to the FDA, which will probably take place in about two years.
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How many injections does the vaccination consist of?
Jackson Booth said the vaccination consists of a primary series, with three injections over a period of four to eight months, followed by a booster shot a year later.
How many participants are being sought for this phase?
Jackson Booth said the goal is to enroll 6,000 people from North America, but said “as many as are willing to participate.”
Are there people who wouldn’t be good candidates for the vaccine study?
Jackson Booth said some people aren’t good candidates for the study, including “people who don’t have an active outdoor life. People who have a chronic or long-term infection or are on immune-suppressing drugs.” Those with unstable medical conditions are also unsuitable.
How are potential subjects screened for the study?
“We do a virtual, short phone screen to find out if that person would be a good candidate,” Jackson Booth said. “We then schedule an on-site appointment where they get a full disclosure of the study. We go over a consent form, detailed medical history, blood work and a physical exam.”
Are there any possible side effects?
As for the side effects of the vaccine, Jackson Booth said, “So far we’re seeing the kind of stuff that’s typical of a shot in the arm. Painful swelling, a little fever, the very typical stuff.”
What is the hoped-for purpose of the vaccine?
Jackson Booth said Lyme disease can lead to long-term consequences, including cardiovascular disease that can lead to death.
“There can be nerve damage, long-term Lyme arthritis. Some people have debilitating or at least frustrating fatigue, things that can persist,” Jackson Booth said. “Because ticks’ ability to survive is longer as our weather patterns change, this disease is increasingly impacting humans. The goal is to be able to stop that.”
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Jackson Booth said, “The warmer the winters are, the ticks don’t die out. We see different migrations of ticks with the deer population.”
Other human activities may also contribute, including the movement of animals, including deer, due to habitat loss.
“I live in Maryland,” Jackson Booth said. “It’s a very normal suburban community. It’s normal to see deer crossing the roads, and foxes and rabbits, things that we didn’t have three years ago because of the impact of humans.”
Are there other efforts to fight Lyme disease?
The first phase of a clinical trial started in May for an injection against Lyme disease, which is being developed at UMass Chan Medical School’s Mass Biologics.
Dubbed LymePrEP, the shot is not a vaccine.
The CDC notes that MassBiologics of UMass Medical School has developed a human monoclonal antibody designed to be used as pre-exposure prophylaxis for Lyme disease, with the goal of providing seasonal protection against Lyme disease.
The CDC said it would likely consist of a single shot people would get each year at the start of tick season.
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What happened to the first Lyme disease vaccine?
Two decades ago, a Lyme disease vaccine came on the market but was discontinued after disappointing sales, even as Lyme disease cases continued to rise.
In December 1998, the FDA approved a vaccine licensed as LYMErix and developed by SmithKline Beecham, now known as GlaxoSmithKline. The development of the vaccine is described in an article from the National Institute of Allergies and Infectious Diseases, part of the National Institutes of Health.
The article says that shortly after licensing, some recipients of the vaccine reported side effects.
In April 2002, GlaxoSmithKline discontinued the vaccine as sales fell. The GGD states that anyone who has received this vaccine probably no longer has protection against Lyme disease.
A review of data by the FDA found no definitive link between the vaccine and harm. GlaxoSmithKline settled a lawsuit with plaintiffs in 2003 alleging adverse effects.