A Trial to Evaluate the Optimal Dose of MV-LASV (V182-001)

Summary

This is a randomized, placebo-controlled, single-center, dose finding phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and an observer-blinded treatment phase. The aim is to investigate the safety, tolerability and immunogenicity of MV-LASV after administration of two different dose levels of MV-LASV. Placebo will be applied to blind the different Treatment schedules.

Timeline

Start

2019-09-26

Primary completion

2020-03-13

Completion

2021-01-15

Publications

• Results Tschismarov R, Van Damme P, Germain C, De Coster I, Mateo M, Reynard S, Journeaux A, Tomberger Y, Withanage K, Haslwanter D, Terler K, Schrauf S, Mullner M, Tauber E, Ramsauer K, Baize S. Immunogenicity, safety, and tolerability of a recombinant measles-vectored Lassa fever vaccine: a randomised, placebo-controlled, first-in-human trial. Lancet. 2023 Apr 15;401(10384):1267-1276. doi: 10.1016/S0140-6736(23)00048-X. Epub 2023 Mar 16.

Drugs

Indications