Lyme vaccine trial underway
Marshfield Clinic Research Institute seeks participants
FOR THE STAR JOURNAL
Healthy adults and children age five and older who spend time outdoors are needed for a Lyme disease vaccine trial.
Marshfield Clinic Research Institute is the sole participant from the United States’ Midwest in a worldwide Pfizer Phase 3 clinical trial, Vaccine Against Lyme for Outdoor Recreationists (VALOR). The trial will investigate the efficacy, safety and immunogenicity of their investigational Lyme disease vaccine candidate, VLA15.
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. If untreated, Lyme disease can sometimes progress to more a complicated disease involving the heart, nervous system, or joints.
Today there are no vaccines approved to prevent Lyme disease. This research study is evaluating if an investigational vaccine is safe and effective for preventing the disease.
“Lyme disease is a threat for all of us in the Midwest who recreate outdoors in the summer,” said Dr. Matthew Hall, a Marshfield Clinic infectious disease physician and researcher. “A vaccination that could provide some reassurance against contracting this life-altering disease would be a game-changer.”
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.
Study participants will be randomly assigned to receive the study vaccine or a placebo.
This study will last about 30 months. During this time, participants will have at least seven in-clinic study visits, including four to 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 vaccine and study-related procedures will be provided at no cost.