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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
The 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 and will be administered in two different dose levels by intra muscular (i.m.) injection.
A sterile physiological saline solution will be used as placebo to ensure blinding of the treatment with low dose MV-LASV and placebo within treatment group A. Additionally, the Placebo will be used as a control arm to enable comparison of treatment reactions within treatment groups B and C.
University of Antwerpen, Centre for the Evaluation of Vaccination (CEV)
Antwerp, Belgium
Rate of solicited and unsolicited Adverse Events (AEs)
Rate of solicited and unsolicited adverse events (AEs) during the treatment period up to day 56
Time frame: 56 days
Rate of Serious Adverse Events (SAEs)
Rate of Serious Adverse Events (SAEs) during the treatment period up to study day 365
Time frame: 365 days
Cell-mediated immunity as confirmed by the presence of functional CD4+ and CD8+ T-cells
Cell-mediated immunity specific for LASV up to day 56 as confirmed by the presence of functional CD4+ and CD8+ T-cells
Time frame: 56 days
Measurement of anti-LASV antibodies determined by Enzyme-linked Immunosorbent Assay (ELISA)
Measurement of anti-LASV antibodies up to day 56 determined by Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: 56 days
Quantification of functional, neutralizing antibodies via Virus Neutralization Tests (VNT)
Quantification of functional, neutralizing antibodies on days 0, 28 and 56 via Virus Neutralization Tests (VNT)
Time frame: 56 days
Rate of abnormal laboratory parameters
Rate of abnormal laboratory parameters until day 56
Time frame: 56 days
RT-qPCR Analysis of MV-LASV Viral Vector in Human Blood, Urine, and Saliva Samples
Shedding of live recombinant virus up to day 42
Time frame: 42 days
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