A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults
Public ClinicalTrials.gov record NCT07226882. 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, PLACEBO-CONTROLLED, DOUBLE-BLINDED, RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF DIFFERENT VACCINATION SCHEDULES OF 6-VALENT OSPA-BASED LYME DISEASE VACCINE, VLA15, IN HEALTHY ADULT PARTICIPANTS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to learn about the safety and effects of the Lyme disease vaccine (called VLA15) when given at different time points. This study is seeking participants who: * are generally healthy and between 18 and 44 years of age, * have never had a vaccine for Lyme disease before, * are not currently taking, or haven't recently taken, medicines like chemotherapy, blood products, or blood thinners, and * 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 5 doses through a shot in the upper arm. Four doses will be the study vaccine (VLA15), and 1 dose will be saltwater. The study will compare the experiences of people receiving the study vaccine at different time points. This will help see if the study vaccine is safe and will help understand its effect on the body. Participants will take part in this study for about 2 years. During this time, the participants will have 11 planned visits - 8 will be at the study clinic and 3 will be done over the phone. The clinic visits may include having a health check, giving a small amount of blood (about 20 mL or 4 teaspoons), and getting the study vaccine or saltwater as a shot.
Study identification
- NCT ID
- NCT07226882
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 207 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 44 Years
- 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
- Nov 18, 2025
- Primary completion
- Jan 26, 2028
- Completion
- Jan 26, 2028
- Last update posted
- May 5, 2026
2025 – 2028
United States locations
- U.S. sites
- 6
- U.S. states
- 3
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| IMA Clinical Research Warren | Warren Township | New Jersey | 07059 | — |
| Smith Allergy and Asthma Specialists | Cortland | New York | 13045 | — |
| Smith Allergy & Asthma Specialists | Horseheads | New York | 14845 | — |
| Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) | Pittsburgh | Pennsylvania | 15236 | — |
| Northeast Clinical Trials Group | Scranton | Pennsylvania | 18510 | — |
| Preferred Primary Care Physicians | Uniontown | Pennsylvania | 15401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07226882, 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 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07226882 live on ClinicalTrials.gov.