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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 44
Healthy Volunteers: t
View:

• 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.

Locations
United States
Pennsylvania
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
NOT_YET_RECRUITING
Pittsburgh
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
RECRUITING
Pittsburgh
Preferred Primary Care Physicians
RECRUITING
Uniontown
Virginia
Clinical Research Partners, LLC
NOT_YET_RECRUITING
Richmond
Amherst Family Practice, P.C.
NOT_YET_RECRUITING
Winchester
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-11-19
Estimated Completion Date: 2028-02-14
Participants
Target number of participants: 200
Treatments
Experimental: Group 1
Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 3. Injections will be given as intramuscular shots.
Experimental: Group 2
Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 5. Injections will be given as intramuscular shots.
Experimental: Group 3
Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 7. Injections will be given as intramuscular shots.
Experimental: Group 4
Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 9. Injections will be given as intramuscular shots.
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov