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.
