A major new Lyme vaccine clinical trial has arrived on Nantucket, and a new mobile clinic area has been established at the rear parking lot of the VFW facility off New South Road.
"We're up and running," said Joe Small, a patient liaison with Care Access, the company facilitating the vaccine trial on Nantucket. "Now it's about how we get people to respond."
The vaccine - manufactured by the pharmaceutical giant Pfizer and its partner Valneva - is now in the third and final phase of a clinical trial. With Nantucket's incidence rate of tick-borne diseases among the highest in the nation, the island was selected as one of the sites for the clinical trial of the vaccine, along with Martha's Vineyard, Block Island, Maine, and other "Lyme disease-endemic" areas in the U.S. and Europe.
Pfizer is contracting with Care Access, a decentralized research organization, to operate the vaccine clinic at the VFW and has partnered with Dr. Tim Lepore, the island’s leading expert on tick-borne diseases, as well as Briarpatch Pediatrics’ Dr. Leif Norenberg, to help roll out the clinical trial on Nantucket.
Island residents can visit www.lymetrial.com to pre-qualify for the vaccine clinical trial, and if eligible, can receive compensation up to $400 for participating in the trial.
So far more than 200 island residents have initiated the pre-screening process, and Care Access' Dr. Tyler Miller told the Current he expects the first patients to have their initial visits at the VFW clinic on Thursday.
The vaccine - dubbed VLA15 - is a “traditional protein-based vaccine,” Dr. Miller said, and is not an mRNA vaccine.
Dr. Lepore described it as similar to the LYMErix vaccine that was available in the late 1990s before it was pulled from the market over concerns regarding autoimmune reactions, despite evidence it was safe.
Care Access vaccine clinic includes two mobile trailers and three service vehicles at the VFW, along with a number of rented tents, and as many as 10 staff members who are commuting from Cape Cod.
Anyone over the age of 5 will be eligible to participate in the clinical trial, although there will be caps on the number of patients in different age groups. Individuals who have previously had Lyme disease will be able to participate in the trial, but those who have had the LYMErix vaccine, or a severe case of Lyme, will be prohibited. In addition, there will be a restriction on anyone who has had a tick bite within the previous four weeks.
"We're conducting a very focused outreach to a segment of our society on the Cape and Islands who happen to work outside, predominantly in landscaping and the construction trades," Small said. "We want to make sure we can reach them and the community in English, Spanish, and Portuguese."
Small said Care Access is working on PSAs in those languages to encourage participation.
Nantucket continues to have one of the highest incidence rates of tick-borne diseases in the country, with Lyme disease the No. 1 culprit. Since 2019, more than 500 cases of Lyme have been diagnosed on Nantucket, according to Nantucket Cottage Hospital’s infection prevention manager Elizabeth Harris.
And that number is strictly confirmed laboratory tests, so it doesn’t include cases in which clinicians diagnosed obvious incidences of Lyme disease (for example, when a patient’s bullseye rash is prominent) and prescribed antibiotics without laboratory confirmation. It also does not encompass patients who may have acquired Lyme disease while visiting Nantucket but were diagnosed elsewhere.
Nationally, the CDC estimates that Lyme disease affects more than 476,000 people annually.
Participants in the Pfizer trial would receive three doses: one shot to start; a second shot 50 to 70 days later, and a booster dose in mid- to late-2023. Half of the recipients would receive a placebo.
Overall, the clinical trial aims to have roughly 6,000 participants in the U.S. and Europe.