What is Lyme Disease?
Lyme disease is caused by a bacteria that is transferred to humans
through the bite of an infected tick. Anyone can get Lyme disease,
but it is more common in children and teens.
People who get Lyme disease often get a red circular rash (called
a “bullseye rash”) around the tick bite and may feel tired, achy, and
feverish.
In most cases, Lyme disease can be treated with antibiotics. If left
untreated, the bacteria that causes Lyme disease can spread through
bloodstream and cause serious problems in the brain, joints, and heart.
Right now, the best way to prevent Lyme disease is to prevent tick bites.
About the Study
The purpose of this study is to learn more about the safety of an
investigational Lyme vaccine in people between the ages of 5-17
years old.
About [3,000] participants will be enrolled at study sites in the United
States.
Why Consider Volunteering?
Currently, there are no approved vaccines available to prevent Lyme disease. Before a new vaccine can be approved, it must first be tested in a series of clinical trials, also known as research studies. All clinical trials are carefully designed and monitored to ensure the health and safety of the volunteers that make them possible.
Make an Important Contribution
By choosing to volunteer for this new study, participants could receive an investigational vaccine that may help to prevent Lyme disease. Participants will represent others like them – in age, gender, race, ethnicity, and from communities like their own. Including people from different backgrounds will help us develop a Lyme disease vaccine that is more likely to be effective for everyone.
Joining a clinical trial is an important, personal decision. Thank you
for considering this study.
What to expect
If your child or teen is interested in participating, the study team may schedule a pre-study visit to determine if this study is a good fit for him/her.
Eligible participants will be randomly assigned to receive the study vaccine or placebo (an injection that looks like the study vaccine but does not contain any active ingredients).
Participants are 3 times more likely to receive the study vaccine than placebo. Participants, parents, and doctors will not know which has been assigned.
Participants will receive 4 shots in the upper arm: 3 in the first 6 months, and a booster 1 year later.
Participants will be enrolled for about 2 years, including 6 planned in-office visits and 2 follow-up phone calls.
Participants may be reimbursed up to $1,276 for study-related expenses like travel.
Qualified participates are:
Children or teens 5 to 17 years old
Children or teens in good health
Children or teens who have not been diagnosed with Lyme disease in the past 3 months
