A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine (NCT07500506)
A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A FIFTH DOSE OF 6-VALENT OSPA-BASED LYME DISEASE VACCINE, VLA15, IN HEALTHY PARTICIPANTS ≥7 YEARS OF AGE
🩺 Plain-English Summary (8th-Grade Level)
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. * are not currently taking, or haven't recently taken, medicines like chemotherapy, blood products, or blood thinners. * are not pregnant or breastfeeding and do not plan to become pregnant while receiving the study vaccine. All participants in this study will receive a total of 1 dose through a shot in the upper arm, either VLA15 or saline shot (saltwater). The study will compare the experiences of people receiving the study vaccine or saltwater shot. Participants will take part in this study for about 12 months. During this time, they will have 4 planned clinic visits. The clinic visits may include having a health check, giving a small amount of blood and getting the study vaccine or saltwater as a shot at the first visit.
Who can join: Review the eligibility criteria below.
Location: Northern Light Eastern Maine Medical Center — Bangor, Maine
Age range: 7 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (22 Sites)
- Northern Light Eastern Maine Medical Center — Bangor, Maine
- Northern Light Family Medicine and Residency Center — Bangor, Maine
- University of Massachusetts Chan Medical School — Worcester, Massachusetts
- Hunterdon Medical Center — Flemington, New Jersey
- Smith Allergy and Asthma Specialists — Cortland, New York
- Smith Allergy & Asthma Specialists — Horseheads, New York
- Altoona Center For Clinical Research — Duncansville, Pennsylvania
- Allegheny Health and Wellness Pavilion — Erie, Pennsylvania
- Central Erie Primary Care — Erie, Pennsylvania
- Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) — Pittsburgh, Pennsylvania
- Preferred Primary Care Physicians, Preferred Clinical Research - St.Clair — Pittsburgh, Pennsylvania
- Robert Packer Hospital — Sayre, Pennsylvania
- Frontier Clinical Research, LLC — Scottdale, Pennsylvania
- Northeast Clinical Trials Group — Scranton, Pennsylvania
- Frontier Clinical Research, LLC — Smithfield, Pennsylvania
- Preferred Primary Care Physicians — Uniontown, Pennsylvania
- Velocity Clinical Research, Providence — East Greenwich, Rhode Island
- The University of Vermont Medical Center Inc. — Burlington, Vermont
- Amherst Family Practice, P.C. — Winchester, Virginia
- Milestone Research Inc. — London, Ontario
- Stouffville Medical Research Institute Inc. — Stouffville, Ontario
- Diex Recherche Inc. Division Sherbrooke — Sherbrooke, Quebec
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Lyme Disease
- A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure — Pikesville, Maryland
- A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age) — Truro, Nova Scotia
- Evaluation, Treatment, and Follow-up of Patients With Lyme Disease — Bethesda, Maryland
- Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure — Washington D.C., District of Columbia
- A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations — Bethesda, Maryland
Explore by condition: All Lyme Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.