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Clinical Trials in the USA / NCT07226882
Active, not recruiting Phase 3

A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults

NCT07226882 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2025-11-19
Last updated
2026-05-06

Condition(s) studied

Lyme Borreliosis

Investigational drug(s) / intervention(s)

VLA15 →Placebo

VLA15: Participants will receive IM injection of 6-valent OspA-based Lyme disease vaccine

Placebo: Saline

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
44 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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. Exclusion Criteria: * 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 anticoagulant therapy in recent medical history. * Any prior Lyme disease vaccination, or recent or concurrent participation in a separate interventional study. * Staff or direct family of the study site staff and Sponsor.

Primary outcome measure(s)

  • Geometric Mean Concentration (GMC) of Anti-Outer Surface Protein A (OspA) Immunoglobulin G (IgG) — At 1 month after the fourth VLA15 dose
  • Geometric Mean Fold Rise (GMFR) of Anti-Outer Surface Protein A (OspA) Immunoglobulin G (IgG) Concentrations — Before the first dose to 1 month after the fourth VLA15 dose
  • Sero-Response Rate Based on Anti-Outer Surface Protein A (OspA) Immunoglobulin G (IgG) Concentrations. — Before the first dose to 1 month after the fourth VLA15 dose
  • Percentage of Participants With Local Reactions For Each Group — Within 7 days after each vaccination
  • Percentage of Participants With Systemic Events For Each Group — Within 7 days after each vaccination
  • Percentage of Participants With Adverse Events (AEs) For Each Group — Within 1 month after each vaccination
  • Percentage of Participants With Serious Adverse Events (SAEs) For Each Group — From the time the participant provides informed consent up to approximately 6 months after the last vaccination
  • Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) For Each Group — From the time the participant provides informed consent up to approximately 6 months after the last vaccination

Trial sites (6)

FacilityCityRegionStatus
IMA Clinical Research Warren Warren Township New Jersey
Smith Allergy and Asthma Specialists Cortland New York
Smith Allergy & Asthma Specialists Horseheads New York
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) Pittsburgh Pennsylvania
Northeast Clinical Trials Group Scranton Pennsylvania
Preferred Primary Care Physicians Uniontown Pennsylvania

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07226882 on ClinicalTrials.gov ↗ ← All trials in the USA