Lyme disease is a tick-borne illness that can cause serious long-term symptoms if left untreated. For people who live in areas where ticks are common, a preventative vaccine would be better than current measures like insect repellants and checking for ticks. Currently, there are no approved vaccines available to prevent Lyme disease in exposed populations. This clinical trial will evaluate if an investigational vaccine is safe and effective in preventing Lyme disease in people 5 years of age and older. By choosing to volunteer, you will represent others like you – in age, race, ethnicity, and from communities like yours.
Joining a clinical trial is an important and personal decision for you and your family. We hope it is one you will consider.
Who May Participate
Healthy children (between 5 and 17 years old) and adults (18 years of age and older) who live in places or participate in activities that increase their risk for Lyme disease may be eligible to participate. Risk factors for Lyme disease include:
- Outdoor occupations such as landscaping, forestry, or wildlife and parks management
- Frequent outdoor recreational activities such as hiking, camping, fishing, hunting, or gardening
- Living in or frequently visiting wooded areas, tree lines, tall grass, open fields, lakesides, or riversides
- Owning a pet that may return from outdoors with attached ticks
Note: These are not the only eligibility criteria for this clinical research study. A clinical research team member will help determine if this study is right for you based on all participation criteria.
About the Lyme Disease Vaccine Study
This study is comparing the investigational (study) vaccine against a placebo (shot with no active ingredient) to learn if it is safe and effective in preventing Lyme disease. If you choose to participate, you will receive 4 injections in your upper arm and be asked to attend at least 7 in person study visits, including 4-5 visits with blood draws, over the course of 30 months. You can change your mind and leave the study at any time. There is no cost to participate, and you will be reimbursed for expenses and time related to completing certain study tasks. You do not need health insurance to take part in this study.
How Can I Learn More?
Deciding to join a clinical trial is a personal and important decision for you and your family. If you’d like to learn more, please call 1-800-836-0388 or email firstname.lastname@example.org. The study team will answer your questions and see if you qualify to participate.