Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis

Summary

Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age. 180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the deltoid region on Days 0, 28 and 56. Study participants will be followed up until one year after first vaccination. Booster Extension: Subjects in the 48µg and 90µg Treatment groups who received a complete Primary immunization schedule will be included into a Booster Extension 13 months after the first immunization.

Timeline

Start

2017-01-31

Primary completion

2017-09-28

Completion

2019-01-16

Publications

• Bezay N, Hochreiter R, Kadlecek V, Wressnigg N, Larcher-Senn J, Klingler A, Dubischar K, Eder-Lingelbach S, Leroux-Roels I, Leroux-Roels G, Bender W. Safety and immunogenicity of a novel multivalent OspA-based vaccine candidate against Lyme borreliosis: a randomised, phase 1 study in healthy adults. Lancet Infect Dis. 2023 Oct;23(10):1186-1196. doi: 10.1016/S1473-3099(23)00210-4. Epub 2023 Jul 4.

Drugs

Indications