NCT05477524

A study for healthy adults and children age 5+, who live in or often visit outdoor areas that may expose them to ticks.  We’re researching a potential vaccine for Lyme Disease.

The VALOR clinical trial is studying a potential Lyme Disease vaccine to see if it may protect people against contracting Lyme Disease (also called Lyme borreliosis).

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Who may participate

Participating in a clinical trial is an important and personal decision.  Thank you for considering the VALOR clinical trial. This study may be an option for you or your child if you live in areas where ticks that carry Lyme disease are found. You also need to regularly participate in activities that might put you in contact with ticks.

Some of these activities may include:

  • Living in or frequently visiting wooded areas, tree lines, tall grass, open fields, lakesides, or riversides
  • Hiking, camping, fishing, hunting, or gardening
  • Landscaping, forestry, wildlife or parks management
  • Pet ownership – such as dogs or cats that may have ticks attached
Condition

Healthy volunteers

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age

5+ years old

The age a person must be to participate in a clinical trial.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

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What to expect

Half of VALOR Study participants will receive the study vaccine; the other half will receive a placebo shot. Study participants will be randomly assigned to either receive the study vaccine or a placebo shot. Neither you nor the study doctor will know which group you have been assigned.

You or your child will receive 4 doses during your time in the study. 3 primary doses will be given before or during the first ‘Lyme season’ (typically spring through fall), followed by a booster dose about one year later.

Blood samples will be taken when you join the study then 1 month after the first doses, 1 month after the 4th dose, and at the end of the second ‘Lyme season’. Additional blood samples will be taken if you visit the study clinic for an illness that could be Lyme Disease.

Length of study treatment

About 30 months or 2 ½ years

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits

Up to 7 study visits

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

About Lyme Disease

Lyme disease is the most common tickborne disease in North America and Europe. Lyme disease may cause rash, fever, and fatigue. If left untreated, Lyme disease can progress to cause severe, sometimes permanent symptoms. Each year, an estimated 476,000 people in the U.S and more than 200,000 people in Europe are diagnosed and treated for Lyme disease.

Lyme Disease often impacts people who are regularly outdoors for work or recreational activities.

Currently, there are no approved vaccines to prevent Lyme disease.

About Lyme Disease

Symptoms of Lyme Disease

The most common and distinct symptom of Lyme disease is an enlarging, circular red rash around the tick bite, called erythema migrans (EM). This rash usually develops between 3 – 30 days after being bitten. Other symptoms like fever, headache, chills, joint aches, and swollen lymph glands may occur in addition to the rash. 

If the study doctor suspects you or your child has an EM rash, they may ask to collect a small 2mm skin sample from the area of the rash, called a skin punch biopsy*, in addition to a blood sample for tests to help diagnose Lyme disease.

*The skin punch biopsy is voluntary; you can still participate in study if you decline the biopsy.

Symptoms of Lyme Disease