MV-LASV vaccine candidate is a recombinant, live-attenuated, viral vectored vaccine, based on the backbone of the measles Schwarz virus strain for prophylaxis of Lassa infection
MV-LASV vaccine candidate is indicated for at-risk populations during outbreaks of Lassa Fever an emerging infectious disease.
MV-LASV is administered in two different dose levels by intramuscular (i.m.) injection. These dosages are under evaluation in a phase 1 clinical trial.
Clinical Trial NCT04055454: A Trial to Evaluate the Optimal Dose of MV-LASV
- This is a prospective, interventional, observer-blinded, randomized, phase I trial, comparing different dose levels of MV-LASV. As a safety precaution, the study will begin with an enrollment of two successive unblinded dose groups of sentinel participants randomized into groups of four in an open-label fashion (group A and B).
- Thereafter, 52 participants will be enrolled in an observer-blinded, randomized manner into one of the three treatment groups (A, B or C). Placebo will be applied to blind the different Treatment schedules.
- After the screening visit, participants will be enrolled in one of three Treatment groups. Visits for immunogenicity sample collection and safety assessments will be performed for 56 days, and additionally, subjects will for long-term follow-up up to 365 days.
- The investigator and site personnel assessing Adverse Events (AEs), all participants, as well as the sponsor's representatives involved in the monitoring and conduct of the study will be unblinded to which vaccine was administered within the unblinded treatment phase. Only the site personnel performing randomization, reparation and administration of Investigational Medicinal Product (IMP) will be unblinded within the randomized observer-blinded treatment phase.