NCT03970733

Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis

ALTERNATIVE SCHEDULE STUDY FOR VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS, IN HEALTHY ADULTS AGED 18 TO 65 YEARS - A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (lower or higher dose) or Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1, Day 57 and Day 180. In the Booster Phase subjects from the higher dose group who completed their primary immunization schedule according to protocol will be randomized 2:1 to receive an additional higher dose VLA15 vaccination or Placebo at Month 18. Study duration in the Main Study Phase per subject is a maximum of 20 months. Overall study Duration is estimated to be 22 months. Study duration per subject in the Booster Phase is a maximum of approximately 13 months. Study duration per subject in the Main Study Phase and Booster Phase together is estimated to be a maximum of approximately 33 months. Overall study duration (i.e., First-Subject-In to Last-Subject Out/ end of Booster Phase) is estimated to be approximately 37 months.

Detailed description

This is a randomized, observer-blind (subject, Sponsor and investigator/site staff involved in Clinical Evaluation of subjects are blinded), Placebo controlled, multicenter Phase 2 study. In Main Study Phase a total of 246 healthy subjects,aged 18 to 65 years, were randomized 2:2:1 to receive either VLA15 with Alum (lower or higher doser Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1 (Month 0), Day 57 (Month 2) and Day 180 (Month 6). Subjects from the higher dose group who completed their primary immunization schedule according to protocol, will be randomized 2:1 to receive an additional injection of the higher dose VLA15 with Alum or Placebo in a Booster Phase. The additional vaccination is administered as intramuscular injection approximately 18 months after the first immunization.

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: 2019-07-01
• Primary completion: 2020-04-07
• Completion: 2022-03-28
• First posted: 2019-05-31
• Last updated: 2023-04-21
• Results posted: 2021-07-08

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study