NCT07226882

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

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: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 3, randomized, parallel-group, placebo-controlled, double-blinded (third-party unblinded) study to evaluate the safety, tolerability, and immunogenicity of different vaccination schedules of the 6-valent OspA-based Lyme disease (LD) vaccine, VLA15, in healthy participants 18 through 44 years of age. Participants will be randomized in a 1:1:1:1 ratio to 1 of the 4 parallel study groups. Each participant will receive 4 doses of VLA15 and 1 dose of placebo (saline) at different time points. This study will use an external data monitoring committee (EDMC). The EDMC is independent of the Pfizer study team and includes only external members. The EDMC charter describes the role of the EDMC in more detail. Approximately 200 participants will be enrolled in the study. Healthy individuals 18 through 44 years of age who are willing to comply with all study procedures and provide signed informed consent will be enrolled. Pregnant or breastfeeding individuals and fertile individuals who are unwilling or unable to use effective contraceptive methods as outlined in this protocol will not be enrolled. Individuals who have contraindication to vaccination, conditions or treatments that can inhibit the ability to mount an immune response to a vaccine, or other conditions that may increase the risk of study participation will be excluded from this study. Individuals who have previously received a licensed or investigational vaccine for LD will also be excluded from this study.

Conditions

• Lyme Borreliosis

Interventions

Type	Name	Description
BIOLOGICAL	VLA15	Participants will receive IM injection of 6-valent OspA-based Lyme disease vaccine
BIOLOGICAL	Placebo	Saline

Timeline

• Start date: 2025-11-19
• Primary completion: 2028-01-27
• Completion: 2028-01-27
• First posted: 2025-11-12
• Last updated: 2026-04-17

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study