Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population
Public ClinicalTrials.gov record NCT04801420. 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
SAFETY AND IMMUNOGENICITY STUDY OF VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS: A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY IN A HEALTHY PEDIATRIC AND ADULT STUDY POPULATION
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A) and Booster Phase (Part B). The study will compare the safety and immunogenicity of two different primary immunization schedules applying three (Month 0-2-6) or two (Month 0- 6) vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included. Subjects with a history of Lyme borreliosis (previous infection with Borrelia) as well as Borrelia naïve subjects will be enrolled. Study duration per subject will be a maximum of 50 months per subject.
Study identification
- NCT ID
- NCT04801420
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 625 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 65 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
- Mar 8, 2021 (Actual)
- Primary completion
- Mar 25, 2022 (Actual)
- Completion
- Jul 2, 2025 (Actual)
- Last update posted
- Sep 15, 2026
2021 – 2025
United States locations
- U.S. sites
- 19
- U.S. states
- 7
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| New England Research Associates | Bridgeport | Connecticut | 06606 | — |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | — |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | — |
| Pediatric Associates of Conn. PC | Waterbury | Connecticut | 06708 | — |
| Clinical Research Institute, Inc. | Minneapolis | Minnesota | 55402 | — |
| Foundation Pediatrics | East Orange | New Jersey | 07018 | — |
| Med Clinical Research Partners, LLC | Irvington | New Jersey | 07111 | — |
| Meridian Clinical Research LLC | Binghamton | New York | 13905 | — |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | — |
| Advantage Clinical Trials | The Bronx | New York | 10467 | — |
| Velocity Clinical Research, Inc. | Cleveland | Ohio | 44122 | — |
| Allegheny Health and Wellness Pavilion | Erie | Pennsylvania | 16506 | — |
| Liberty Family Practice | Erie | Pennsylvania | 16508 | — |
| Lockman & Lubell Pediatric Associates | Fort Washington | Pennsylvania | 19034 | — |
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| The Miriam Hospital | Providence | Rhode Island | 02906 | — |
| Velocity Clinical Research Providence | Warwick | Rhode Island | 02886 | — |
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 NCT04801420, 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 Sep 15, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04801420 live on ClinicalTrials.gov.