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Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study.

NCT03769194 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2023-01-10

Study results available
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Summary

This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study conducted in two study phases: a run-in phase and a main study phase. The study was investigated 3 doses of a multivalent OspA (Outer Surface Protein A) based Lyme vaccine (VLA15) in healthy adults aged 18 to 65 years of age. Study participants received 3 immunizations of the vaccine at a monthly interval. The study assessed the immune response as well as the safety profile of the vaccine.

Conditions

  • Lyme Borreliosis

Interventions

BIOLOGICAL

VLA15

a multivalent recombinant Outer surface protein A (OspA) based vaccine candidate

BIOLOGICAL

Placebo

Placebo: PBS (Phosphate Buffered Saline)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2019-12-18
Completion
2020-10-02
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03769194 on ClinicalTrials.gov