A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine
Public ClinicalTrials.gov record NCT07500506. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07500506
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,712 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 7 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 7, 2026
- Primary completion
- Dec 3, 2026
- Completion
- Dec 3, 2026
- Last update posted
- May 5, 2026
2026
United States locations
- U.S. sites
- 19
- U.S. states
- 8
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northern Light Eastern Maine Medical Center | Bangor | Maine | 04401 | Not yet recruiting |
| Northern Light Family Medicine and Residency Center | Bangor | Maine | 04401 | Not yet recruiting |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01655 | Recruiting |
| Hunterdon Medical Center | Flemington | New Jersey | 08822 | Not yet recruiting |
| Smith Allergy and Asthma Specialists | Cortland | New York | 13045 | Recruiting |
| Smith Allergy & Asthma Specialists | Horseheads | New York | 14845 | Recruiting |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | Recruiting |
| Allegheny Health and Wellness Pavilion | Erie | Pennsylvania | 16506 | Recruiting |
| Central Erie Primary Care | Erie | Pennsylvania | 16508 | Recruiting |
| Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) | Pittsburgh | Pennsylvania | 15236 | Recruiting |
| Preferred Primary Care Physicians, Preferred Clinical Research - St.Clair | Pittsburgh | Pennsylvania | 15243 | Not yet recruiting |
| Robert Packer Hospital | Sayre | Pennsylvania | 18840 | Recruiting |
| Frontier Clinical Research, LLC | Scottdale | Pennsylvania | 15683 | Recruiting |
| Northeast Clinical Trials Group | Scranton | Pennsylvania | 18510 | Recruiting |
| Frontier Clinical Research, LLC | Smithfield | Pennsylvania | 15478 | Recruiting |
| Preferred Primary Care Physicians | Uniontown | Pennsylvania | 15401 | Not yet recruiting |
| Velocity Clinical Research, Providence | East Greenwich | Rhode Island | 02818 | Not yet recruiting |
| The University of Vermont Medical Center Inc. | Burlington | Vermont | 05401 | Not yet recruiting |
| Amherst Family Practice, P.C. | Winchester | Virginia | 22601 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07500506, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07500506 live on ClinicalTrials.gov.