NCT04801420

Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population

SAFETY AND IMMUNOGENICITY STUDY OF VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS: A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY IN A HEALTHY PEDIATRIC AND ADULT STUDY POPULATION

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 625 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 5 Years – 65 Years
• Healthy volunteers: Accepted

Summary

VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A) and Booster Phase (Part B). The study will compare the safety and immunogenicity of two different primary immunization schedules applying three (Month 0-2-6) or two (Month 0- 6) vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included. Subjects with a history of Lyme borreliosis (previous infection with Borrelia) as well as Borrelia naïve subjects will be enrolled. Study duration per subject will be a maximum of 50 months per subject.

Detailed description

VLA15-221 is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study, which is set up in two parts: Main Study Phase (Part A) and Booster Phase (Part B). In Part A 600 subjects aged 5-65 years will be enrolled 1:1:1 into three groups: Group 1 will be vaccinated with VLA15 at Month 0-2-6, Group 2 will be vaccinated with VLA15 at Month 0-6 and with placebo at Month 2 and Group 3 will be vaccinated with placebo at Month 0-2-6. In Part B all eligible subjects will receive booster injections with VLA15 or placebo at Month 18, 30 and 42.

Conditions

• Lyme Borreliosis

Interventions

Type	Name	Description
BIOLOGICAL	VLA15	a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
BIOLOGICAL	Placebo	PBS (Phosphate Buffered Saline)

Timeline

• Start date: 2021-03-08
• Primary completion: 2022-03-25
• Completion: 2025-07-02
• First posted: 2021-03-17
• Last updated: 2025-11-12
• Results posted: 2023-06-07

Locations

22 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study