YOUR CHILD CAN MAKE A DIFFERENCE, VOLUNTEER FOR A LYME DISEASE VACCINE STUDY
The VALOR investigational Lyme disease vaccine study is underway for healthy children 5 years of age or older who live in or frequently visit areas that may expose them to ticks.
About the Lyme Disease Vaccine Study
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 rashes, fever, and fatigue. Children account for a large portion of those at the greatest risk of Lyme disease. If left untreated, Lyme disease can progress to cause severe, sometimes permanent symptoms. Currently, there are no approved vaccines available to prevent Lyme disease.
VALOR is an ongoing clinical trial which has already enrolled more than 4,000 adults and 300 children. This study is evaluating if an investigational Lyme vaccine is safe and effective for preventing Lyme disease in people who have been exposed through tick bites.
Joining a clinical trial is an important and personal decision. We hope it is one your family will consider.
Who Can Participate
Healthy children 5 years of age or older who live in or often visit outdoor areas that may expose them to ticks may be eligible to participate. Study participants cannot have been diagnosed with Lyme Disease within 3 months of enrollment.
Activities that may increase the risk of Lyme Disease include:
Live in or frequently visit areas where ticks that carry Lyme disease are found, such as wooded areas, tree lines, open fields, lakesides or riversides
Hiking, camping, fishing, hunting, or gardening
Owning a pet that has returned with ticks attached after being outside
What to Expect
Your child will be randomly assigned to receive the study vaccine or a placebo (shot with no active ingredient). Neither you, your child nor the study doctor will know which has been assigned.
This study will last about 30 months (2 and a half years). During this time, your child will have at least 7 in clinic study visits, including 4-5 visits with blood draws. Additional blood samples may be needed if your child develops symptoms of Lyme disease.
Over the course of the study, you will need to report any changes in your child's health to the study team.
The study vaccine and study-related procedures will be provided at no cost. You do not need health insurance to take part in this study.
Research studies are voluntary, and taking part in a research study is a personal choice. You or your child may leave the study at any time, for any reason.
To learn more, contact the study team:
Email: valorlymestudy@marshfieldresearch.org
Phone: 1-844-256-1469