Last updated on November 2019

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.


Brief description of study

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 will investigate 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 will receive 3 immunizations of the vaccine at a monthly interval. The study will assess the immune response as well as the safety profile of the vaccine.

Detailed Study Description

This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study.

In the Run-in phase, a total of 120 subjects aged 18 to 40 years will be randomized 1:1:1:1 to receive one of three VLA15 doses (VLA15 low dose, VLA15 medium dose, VLA15 high dose) or Placebo (30 subjects per treatment group) as intramuscular vaccinations on Days 1, 29 and 57. Dosing will be adjusted by injection volume.

In the Main Study phase, a total of 450 subjects aged 18 to 65 years will be randomized 2:2:1 to receive one of two VLA15 doses that are selected from the Run-in Phase for further investigation (180 subjects each) or placebo (90 subjects), as intramuscular vaccinations on Days 1, 29 and 57. Subjects will be enrolled in two age groups (18-49 years and 50-65 years) in a ratio of approx. 2:1.

In both study phases, target is to enroll approx. 10 % or more of subjects that are baseline seropositive for Borrelia burgdorferi sensu latu (Bb s.l.).

Clinical Study Identifier: NCT03769194

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