Lyme trials coming to Vineyard

New vaccine offers hope against Lyme epidemic.

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A medical trailer that will be used to facilitate Lyme vaccine trials has arrived on the Vineyard. — Rich Saltzberg

The Vineyard is poised to be a proving ground for an experimental compound to help prevent Lyme disease. Pfizer, the pharmaceutical giant that developed lifesaving COVID-19 vaccines, is working toward a vaccine against Borrelia burgdorferi, the tick-borne bacteria that cause Lyme disease. Pfizer is developing the vaccine with French pharmaceutical company Valneva. Phase 3 trials of the drug will take place on the Vineyard, according to Michael Loberg, president of Vineyard Medical Care and a member of the Tisbury board of health.

Loberg said Pfizer has already conducted a phase 1 trial of the vaccine for safety, and a phase 2 trial of the vaccine for efficacy. The next phase will explore the extent of the protection the vaccine provides, Loberg said.

Vineyard Medical Care will be among the Vineyard facilities assisting with the trial. “For us it’s an easy decision to make to work with them, and we’re pleased they chose the Vineyard to do it,” Loberg said. 

The trials will help address what Loberg described as “one of the major unmet medical needs we have here on Martha’s Vineyard.”

Loberg said he expects four specialized medical trailers will be brought to the Vineyard to facilitate hundreds of people participating in the trial. One of those trailers, he said, came over on Sunday, and is parked at Tisbury Wharf Co. Loberg thanked property owner Ralph Packer for providing space for the trailer.

“What they’re trying to do is reduce the incidence of Lyme disease in areas that are epidemic with Lyme disease, and we are a good place to do the trials,” Loberg said.

In preparation for the trials, Pfizer has reached out to the Island boards of health, Loberg said.

“The boards of health are involved to the extent that we support the project and we’re here to help wherever we can,” Tisbury health agent Maura Valley said. 

Valley said she expects the trials will be in double-blind format and begin in August, with a second shot roughly 60 days later and a booster shot in April. 

“A Lyme disease vaccine would be very beneficial,” Valley said. She described Lyme as “one of our biggest public health issues on the island.” She also said she believes a lot of people will want to sign up for the trials. Information on how to do that should be available in the coming weeks, she said, and referred more detailed questions to trial representative Joseph Small. Small couldn’t immediately be reached for comment. 

Biotech news outlet FierceBiotech reported that the vaccine, VLA15, the only vaccine of its type, could be a game-changer. “Phase 3 success could give Pfizer a clear run at a growing opportunity,” the outlet reported. “The number of reported cases of Lyme disease in the U.S. has tripled since the late 1990s, potentially because of changes in land use that have brought more humans into close contact with tick hosts. Whatever the cause, the rise has led the Centers for Disease Control and Prevention to say new tools for preventing tick-borne diseases are needed urgently. VLA15 is a rare example of such a tool. SmithKline Beecham won approval for a Lyme vaccine in the late 1990s, but pulled it from the market a few years later. Pasteur Mérieux Connaught, now Sanofi, dropped its plans to seek approval for a Lyme vaccine around the same time.”

Pfizer says VLA15 looks promising thus far. “VLA15 is the only Lyme disease vaccine candidate currently in clinical development,” Pfizer’s website states. “This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick. The vaccine covers the six OspA serotypes expressed by Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe. VLA15 has demonstrated strong immunogenicity and safety data in preclinical and clinical studies so far. The program was granted fast-track designation by the U.S. Food and Drug Administration (FDA) in July 2017. Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15.2.”

12 COMMENTS

  1. How can one choose to participate in this trial? I am very interested, as I had life-threatening Lyme & several co-infections a few years ago.

  2. I find this very interesting since before I moved here in 2000 I received a Lymes vaccine. It was my understanding that the pharmaceutical company stopped manufacturing it because not enough people wanted it.

  3. Michael Loberg has been at the forefront of the effort to reduce Lyme and other tick borne diseases. he started the Tick-Borne Illness Prevention initiative that later morphed into the Martha’s Vineyard Tick Program. We all owe him a huge thank you for this and other Board of Health initiatives he has spearheaded over the years.

  4. I took part in the first vaccine trial years ago and received a low dose of the vaccine. I worked in the woods for almost 20 years, received a couple hundred tick bites and have never tested positive for Lyme, although I doubt the vaccine would still be effective after all these years. That vaccine was withdrawn after some anti-vaxer lawsuits but I believe it is still available in Europe.

  5. sign me up– I think I am a perfect candidate for this study– 70 years old, in pretty good shape, often in the woods or fields.. I have intimate contact with about 100 ticks a year.
    What happened to the plan to alter the genome of the white footed mouse ?

    • Don,
      The proposal to use CRISPR technology to alter the genes of the mice will not be implemented for many years and is just in a very early phase. It has to go through a lengthy approval process before it is deployed in even trials. As for the vaccine, it has been a long time coming but as far as I understand it will only protect one against Lyme. The ticks carry many other diseases which the vaccine doesn’t address. In my opinion, the only known effective way to control the tick borne diseases is to reduce the deer population on the island.

      • Very interesting because there are so many strains of Lyme how can one vaccine help them all? Plus many of the ticks carry other disease like Babesia and they aren’t even addressing that. Lastly, I would guess so many people on the island actually have had or have the disease already so how will getting a vaccine effect their bodies?

  6. Lyme disease and its variants have caused innumerable problems in young people over the years on MV, causing, slowed careers, failed attempts of higher education and an inability in general to get on with life. These studies and trials are more than welcome.

  7. Thank you for coming to the Vineyard. Thank you for pushing for all that we have and are going to be getting to cut down on and eventually stop infections illness and death from Lyme.
    I am curious about those who have been tested for chronic Lyme and if they are a subject to study ?
    Again thank you.

  8. This is my second year of getting Lyme disease!! I feel awful!! I want to be able to participate in the trails and get the vaccine!!

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