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

NCT04055454 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-11

No results posted yet for this study

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.

Conditions

  • Lassa Virus Infection

Interventions

BIOLOGICAL

MV-LASV

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • Harmony Clinical Research BVBA

    collaborator OTHER

  • Assign Data Management and Biostatistics GmbH

    collaborator OTHER

  • Themis Bioscience GmbH

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2020-03-13
Completion
2021-01-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04055454 on ClinicalTrials.gov