A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine
Key facts
- Where
- Bangor, Burlington, Cortland, Duncansville, East Greenwich, Erie, Flemington, Horseheads, Pittsburgh, Sayre, Scottdale, Scranton, Smithfield, Uniontown, Winchester, and Worcester, United StatesSee the 19 sites
- Phase
- Phase 3
Where in United States
- Northern Light Eastern Maine Medical CenterBangor, United StatesNot yet recruiting
- Northern Light Family Medicine and Residency CenterBangor, United StatesNot yet recruiting
- The University of Vermont Medical Center Inc.Burlington, United StatesNot yet recruiting
- Smith Allergy and Asthma SpecialistsCortland, United StatesTaking people
- Altoona Center For Clinical ResearchDuncansville, United StatesTaking people
- Velocity Clinical Research, ProvidenceEast Greenwich, United StatesNot yet recruiting
- Allegheny Health and Wellness PavilionErie, United StatesTaking people
- Central Erie Primary CareErie, United StatesTaking people
- Hunterdon Medical CenterFlemington, United StatesNot yet recruiting
- Smith Allergy & Asthma SpecialistsHorseheads, United StatesTaking people
- Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)Pittsburgh, United StatesTaking people
- Preferred Primary Care Physicians, Preferred Clinical Research-St. ClairPittsburgh, United StatesNot yet recruiting
- Robert Packer HospitalSayre, United StatesTaking people
- Frontier Clinical Research, LLCScottdale, United StatesTaking people
- Northeast Clinical Trials GroupScranton, United StatesTaking people
- Frontier Clinical Research, LLCSmithfield, United StatesTaking people
- Preferred Primary Care PhysiciansUniontown, United StatesNot yet recruiting
- Amherst Family Practice P.C.Winchester, United StatesNot yet recruiting
- University of Massachusetts Chan Medical SchoolWorcester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Pfizer
- Trial code
- NCT07500506
- Record updated
- 6 May 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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; Participants must have received 4 doses of VLA15 in the C4601003 study, and have a V7 blood sample available.
Exclusion: Recent or concurrent participation in a separate interventional study; 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; Pregnant or breastfeeding participants; Staff or direct family of the study site staff and Sponsor.