Lyme Disease Prevention Vaccine Trial Begins Recruiting in Vermont
Enrollment is open to participants five years of age and older
The University of Vermont Medical Center and the Vaccine Testing Center at UVM’s Larner College of Medicine will operate as a study site for a worldwide Phase 3 clinical study to investigate the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate. The study, known as the Vaccine Against Lyme for Outdoor Recreationists (VALOR) trial, is sponsored by Pfizer and is enrolling participants five years of age and older.
“Lyme disease is a common illness caused by a bacteria found in ticks. Bites from infected ticks can transfer the bacteria to humans and cause a characteristic rash, fevers, and fatigue,” said Kristen Pierce, M.D., infectious disease specialist at the University of Vermont Medical Center, professor of medicine at the UVM Larner College of Medicine, and principal investigator at the UVM site. “
There are currently no approved vaccines available to prevent Lyme disease in humans. The VALOR research study is evaluating if an investigational vaccine is safe and effective for preventing Lyme disease in people who have been exposed through tick bites.
Healthy adults and children five years of age or older who live in or often visit outdoor areas that may expose them to ticks may be eligible to participate. Trial participants cannot have been diagnosed with Lyme disease within three months of enrollment.
This study will last about 30 months and participants will be randomly assigned to receive the study vaccine or placebo. As part of the study, participants will have at least seven in‐clinic study visits at UVM Medical Center in Burlington, including four or five visits with blood draws. Additional blood samples may be needed if participants develop symptoms of Lyme disease. Over the course of the study, participants will need to report any changes in their health to the study team.
The study is being conducted at up to 50 sites located in areas where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden and the United States. Participants will receive three doses of the vaccine or a saline placebo as a primary vaccination series followed by one booster of the vaccine or saline placebo. Data from the Phase 2 studies continue to demonstrate strong immunogenicity in adults as well as in children with acceptable safety and tolerability profiles in both study populations.
“This vaccine trial highlights the benefit of having a world‐class, academic medical center in Vermont and Northern New York. We can help further develop important new medical interventions needed for our community, such as vaccines, right here with the help of our community and our excellent research teams,” said Stephen Leffler, M.D., president and chief operating officer of UVM Medical Center and professor of emergency medicine at Larner College of Medicine.
“We all should take pride in the partnership between the University of Vermont Medical Center and the Vaccine Testing Center at the Larner College of Medicine,” added Larner College of Medicine Dean Richard Page, M.D. “The local enrollment into this international trial will contribute to the global effort to combat Lyme Disease and its impact on our community and beyond.”
People interested in participating in the VALOR study through the UVM Medical Center can visit the UVM LCOM Vaccine Testing Center Current Opportunities webpage or call 802‐656‐0013 to find out more.