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Tests treatment safety and results for Lyme Disease
Official title A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine
ClinicalTrials.gov ID: NCT07500506
What this study is testing
What is VLA15?
VLA15 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for lyme disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to learn about the safety effects of the Lyme disease vaccine (called VLA15), and its ability to protect people from Lyme disease after a 5th dose of the vaccine. This study is seeking participants who: are generally healthy and 7 years of age and older, have already been vaccinated with 4 doses of VLA15 (from the VALOR study), and have blood sample taken post dose 4.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 and older. Healthy volunteers may be eligible.
You may be able to join if
- Participants who are healthy as determined by medical history and clinical judgment.
- Participants willing and able to comply with all scheduled visits, IP receipt, and other procedures throughout the study.
- Able to provide Informed Consent.
- Participants must have received 4 doses of VLA15 in the C4601003 study, and have a V7 blood sample available.
You likely can't join if
- Pregnant or breastfeeding participants.
- Allergies or contraindications to vaccines or their components.
- Health issues including: blood clotting deficiencies, immunodeficiencies, bone marrow disorder, or uncontrolled psychiatric conditions.
- Receipt of therapies to treat malignancies, blood/plasma products and immunoglobulins, systemic corticosteroids and immunosuppressants, or...
- Recent or concurrent participation in a separate treatment study.
- Staff or direct family of the study site staff and Sponsor.
The study team makes the final eligibility decision.
Where it's taking place
- Bangor, Maine, United States
- Worcester, Massachusetts, United States
- Flemington, New Jersey, United States
- Cortland, New York, United States
- Horseheads, New York, United States
- Duncansville, Pennsylvania, United States
- Erie, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Sayre, Pennsylvania, United States
- Scottdale, Pennsylvania, United States
- Scranton, Pennsylvania, United States
- Smithfield, Pennsylvania, United States
- Uniontown, Pennsylvania, United States
- East Greenwich, Rhode Island, United States
- Burlington, Vermont, United States
- Winchester, Virginia, United States
- London, Ontario, Canada
- Stouffville, Ontario, Canada
- Sherbrooke, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangor, Maine, United States; Worcester, Massachusetts, United States; Flemington, New Jersey, United States; Cortland, New York, United States; Horseheads, New York, United States; Duncansville, Pennsylvania, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.