CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 572 enrolled
Drug / intervention
VLA15 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03769194
NCT03769194Phase 2Completed
CompareCT.gov

Immunogenicity and Safety Study of VLA15, A Multivalent Recombinant OspA (Outer Surface Protein A) Based Vaccine Candidate Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. A Randomized, Controlled, Observer-blind Phase 2 Study.

Pfizer·interventional·Posted Dec 7, 2018·Updated Jan 10, 2023

In Brief

A Phase 2 clinical trial evaluating VLA15 and Placebo for Lyme Borreliosis. Completed, enrolled 572 participants across 9 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLyme Borreliosis
CountriesBelgium, Germany, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 7, 2018
Enrollment StartDec 17, 2018
Primary CompletionDec 18, 2019
Study CompletionOct 2, 2020
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.6 years ago

Interventions

VLA15biological

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

Placebobiological

Placebo: PBS (Phosphate Buffered Saline)