Vermonters interested in participating in a clinical trial for a Pfizer vaccine to protect against Lyme disease will again have that opportunity. But no one previously enrolled through sites that closed in February is eligible.
The University of Vermont Medical Center and UVM’s Larner College of Medicine announced on Friday that they will operate a study site in Burlington and are recruiting adults and children ages 5 and older via the medical school’s Vaccine Testing Center website. Specifically, participants should be healthy people who either work or recreate frequently outdoors where ticks are common.
Called the Vaccine Against Lyme for Outdoor Recreationists, or VALOR, trial, the study will take place over 30 months and involve at least seven visits to a clinic at the Burlington hospital, as well as four or five blood draws, according to a press release.
Lyme disease is caused by tick-borne bacteria that has become increasingly present in Vermont. A Vermont Department of Health study of ticks collected throughout the state in 2020 found that more than half of all ticks were infected with the bacteria, with the greatest percentage of infected ticks — more than 70 percent — found in Chittenden and Franklin counties.
“Bites from infected ticks can transfer the bacteria to humans and cause a characteristic rash, fevers and fatigue,” said Dr. Kristen Pierce in the release. Pierce is the principal investigator for the trial site and a UVM professor, as well as an infectious disease specialist at the UVM Medical Center.
The disease can usually be successfully treated by two to four weeks of antibiotics. In some cases a bout with the disease can also cause longer-term chronic symptoms, though researchers are unsure whether the cause is the continued presence of the bacteria or the body’s immune response.
Currently, there are no approved vaccines capable of preventing Lyme disease in humans, though a vaccine made for dogs is available through veterinary clinics.
Pfizer recently announced successful results of a Phase 2 series of tests that found the vaccine produced an immune system response in participants and did not cause concerning side effects in either children or adults.
The currently active Phase 3 trial will test whether three doses of the vaccine and a booster do better at protecting participants from Lyme disease than the same number of doses of a saline placebo. Participants will not be told whether they are receiving the vaccine or not.
Pfizer and its European partner, Valneva, are conducting the study in Finland, Germany, the Netherlands, Poland, Sweden and the United States, concentrating on locations where Lyme disease is common. The companies have told investors that they plan to pursue commercial approval in both the U.S. and Europe by 2026 if the Phase 3 test shows positive results.
This is the same trial that started last August in locations in Brattleboro and Middlebury operated by a private medical research company called Care Access. Those sites were closed suddenly, and Pfizer and Valneva announced in February that they had found problems with how the sites were being operated.
Pfizer has informed its investigators that people who were previously enrolled at those closed sites will not be eligible to participate in the trial elsewhere, according to UVM Health Network spokesperson Neal Goswami.
UVM Medical Center CEO Stephen Leffler said in the press release that the opening of the trial at the hospital “highlights the benefit of having a world‐class, academic medical center in Vermont and Northern New York.”
