Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population

Summary

VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A) and Booster Phase (Part B). The study will compare the safety and immunogenicity of two different primary immunization schedules applying three (Month 0-2-6) or two (Month 0- 6) vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included. Subjects with a history of Lyme borreliosis (previous infection with Borrelia) as well as Borrelia naïve subjects will be enrolled. Study duration per subject will be a maximum of 50 months per subject.

Timeline

Start

2021-03-08

Primary completion

2022-03-25

Completion

2025-07-02

Publications

• Wagner L, Obersriebnig M, Hochreiter R, Kadlecek V, Larcher-Senn J, Hegele L, Maguire JD, Murphy T, Derhaschnig U, Bezay N, Jaramillo JC, Eder-Lingelbach S, Messier M. Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in children, adolescents, and adults in the USA: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2026 Mar;26(3):314-328. doi: 10.1016/S1473-3099(25)00541-9. Epub 2025 Nov 7.
• Wagner L, Obersriebnig M, Kadlecek V, Hochreiter R, Ghadge SK, Larcher-Senn J, Hegele L, Maguire JD, Derhaschnig U, Jaramillo JC, Eder-Lingelbach S, Bezay N. Immunogenicity and safety of different immunisation schedules of the VLA15 Lyme borreliosis vaccine candidate in adults, adolescents, and children: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2025 Sep;25(9):986-999. doi: 10.1016/S1473-3099(25)00092-1. Epub 2025 Apr 25.

Drugs

Indications