A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Lyme Borreliosis
In brief
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.
Key facts
- Study ID
- NCT07226882
- Run by
- Pfizer
- People needed
- 207
- Starts
- 2025-11-19
- Expected to finish
- 2028-01-27
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older, up to 44. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- IMA Clinical Research Warren — Warren Township, New Jersey, United States
- Smith Allergy and Asthma Specialists — Cortland, New York, United States
- Smith Allergy & Asthma Specialists — Horseheads, New York, United States
- Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) — Pittsburgh, Pennsylvania, United States
- Northeast Clinical Trials Group — Scranton, Pennsylvania, United States
- Preferred Primary Care Physicians — Uniontown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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