Lassa Virus Infection Clinical Trial
Official title:
A Randomized, Placebo-controlled Trial to Evaluate the Optimal Dose of MV-LASV, a New Vaccine Against LASSA Virus Infection, Regarding Safety, Tolerability & Immunogenicity in Healthy Volunteers Consisting of an Unblinded Dose Escalation & an Observer-blinded Treatment Phase
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.
This is a prospective, interventional, observer-blinded, randomized, phase I trial, comparing different dose levels of MV-LASV. As safety precaution, the study will begin with 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 bei enrolled to 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. ;
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