<p>Organizers of a first-of-its-kind Lyme disease vaccine trial on Martha’s Vineyard are still looking for signups, after an initial wave of recruitment has slowed down in recent months.</p>
Organizers of a first-of-its-kind Lyme disease vaccine trial on Martha’s Vineyard are still looking for participants, after an initial wave of recruitment has slowed down in recent months.
Developed by Pfizer in partnership with the French pharmaceutical company Valneva, the Lyme disease vaccine is in the third phase of its clinical trials and is the only Lyme disease vaccine candidate currently in development worldwide. The clinical trial is being managed by Care Access, a company contracted by Pfizer.
Trials for the vaccine, known as VLA15, are being conducted in 50 Lyme-endemic communities across the northern hemisphere, including Europe and the United States. Martha’s Vineyard, which has rates of Lyme disease nearly 10 times as high as the rest of the state, was selected as a trial site earlier this summer.
Although trial organizers initially sought to enroll close to 500 Islander participants, they have only received about 150 signups since beginning the trials in August, according to Calvin Thompson, who works with Care Access. Mr. Thompson said Care Access was looking to enroll as many Islanders as possible, with about 300 spots still open in the trial.
The global phase three trial seeks to enroll approximately 6,000 people.
“It seemed like we had really good initial traction. But then as the season died down, it started to slow down,” Mr. Thompson said.
The vaccine trial involves three doses over an approximately five month period, Mr. Thompson said. Participants will receive a comprehensive physical before getting their first shot, which will contain either the actual investigational product, or a placebo, in a double-blind format.
“We don’t know, the patient doesn’t know,” Mr. Thompson said.
The initial intake process takes about two-to-three hours, Mr. Thompson said, with patients screened for pre-existing conditions. A second follow-up shot is scheduled for 60 days later, and a third follow-up shot is scheduled for 90 days after the second shot. Participants will receive monitoring throughout the trial.
The trial is jointly-based at a site on the Martha's Vineyard Regional High School property, as well as at Vineyard Medical Care in West Tisbury.
Mr. Thompson said the trial is open to anyone on-Island who is active outdoors and over the age of five. He said organizers were particularly interested in signing up more pediatric patients and reaching out to the Brazilian community on the Island.
Vaccine trials are conducted in phases, with early phases seeking to determine the safety and efficacy of the vaccine in animals and smaller human test groups. As the final step in the Lyme vaccine’s clinical trial, the phase three researchers on Martha’s Vineyard are looking to determine the efficacy of the vaccine in preventing Lyme disease among more granular human demographics, including age and ethnicity.
The vaccine has already been determined to be safe, Mr. Thompson said. Researchers are now interested in evaluating its performance.
“They are looking for a decent number of cases where someone will get the vaccine, and be exposed to a tick bite or Lyme, and either avoid infection because they’ve had the vaccine, or not,” Mr. Thompson said.
To sign up for the trial, interested patients can go to helpstoplyme.com, or call 351-222-5112 to register and schedule an intake appointment.

Comments
If you have had Lyme, or have
Thomas Hodgson wtIf you have had Lyme, or have friends who have, you know how miserable this sickness can be. A good vaccine for Lyme would spare many many thousands of people of that misery. If you've been thinking of signing up, do it! Your volunteering can make a positive difference. (I've signed up, and can report that the folks I have interacted with have been on-the-ball, perceptive, thorough, and kind.)
I am currently participating
Nancy Rose Steinbock EdgartownI am currently participating and pleased to be doing so! This is a highly professional, friendly group that is providing an essential service. Given the Lyme disease rates on-island, it is important to have a vaccine that works -- this is especially true for those of us who have been bitten several times, requiring treatment. Lyme, as noted, is a disease that can have long-lasting consequences. Taking part in this important work may have personal and certainly, positive commmunity outcomes.
I have chosen to participate
Linda Vadasz West TisburyI have chosen to participate in this important study and I urge you to sign up, too. We here on the island are at ground zero for Lyme Disease. Many members of my family and friends have endured the consequences that come with exposure to Lyme. It can be painful and long lasting.
The doctors and nurses who are administering the test are considerate and compassionate. Please join us.
It was remarkable to learn
Luigi Oak BluffsIt was remarkable to learn after signing up for the trial that Pfizer and it's affiliates will not be providing the vaccine to participants if/when it is approved. While it's admirable to volunteer for the benefit of others, it's hard to believe a huge pharma company would not provide the courtesy of actually benefiting the volunteers for their contribution and risk. Especially since many receive the placebo. This may explain the lack of momentum to the initial wave of participants. Also, contrary to the two to three hour initial intake mentioned, mine took three and a half hours.
Please tell us how you
Thomas Hodgson wtPlease tell us how you learned this. At the end of the study, half of the participants WILL have received the vaccine. It would seem a reasonable courtesy to offer the other half of the participants the vaccine to those who received a placebo, should they want it. You can be sure the vaccine will be available from doctors and at pharmacies. I was told to allow four hours for intake. It took a little longer. That is a very small extra "sacrifice", considering the potential benefit to our fellow humans. Participants are also being paid to participate, which is a fact you neglected to mention.
I finished my second visit
Schools Out TisburyI finished my second visit recently. I was told during my initial visit that if I was in the half of the test population that had the placebo that I would be offered the vaccine when approved. I'm sure my insurance would cover it, anyway. Seems Luigi is just looking to grumble. There's a 50/50 chance he is getting the vaccine. I agree with others -- the staff is very professional and do a good job of maintaining this double blind study. Getting paid a little bit of money is a bonus, too.
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