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

NCT04055454 | Completed Phase 1 DMC

• 3 other identifiers: V182-001MV-LASV-1012018-003647-40
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lassa Virus Infection; Prevention; Vaccine; Phase 1; Lassa Fever

Outcome Measures

Primary Outcomes (1)

• Rate of solicited and unsolicited Adverse Events (AEs)

  Rate of solicited and unsolicited adverse events (AEs) during the treatment period up to day 56

  56 days

Secondary Outcomes (6)

• Rate of Serious Adverse Events (SAEs)

  365 days

• Cell-mediated immunity as confirmed by the presence of functional CD4+ and CD8+ T-cells

  56 days

• Measurement of anti-LASV antibodies determined by Enzyme-linked Immunosorbent Assay (ELISA)

  56 days

• Quantification of functional, neutralizing antibodies via Virus Neutralization Tests (VNT)

  56 days

• Rate of abnormal laboratory parameters

  56 days

Study Arms (3)

MV-LASV low dose: treatment group A

EXPERIMENTAL

In total 24 participants will receive two low dose treatments with MV-LASV on day 0 and 28.

Biological: MV-LASV; Other: Placebo

MV-LASV high dose: treatment group B

EXPERIMENTAL

In total 24 participants will receive two high dose treatments with MV-LASV on day 0 and 28.

Biological: MV-LASV

Placebo: treatment group C

PLACEBO COMPARATOR

In total 12 participants will receive placebo treatment on day 0 and 28.

Other: Placebo

Interventions

MV-LASV BIOLOGICAL

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.

MV-LASV high dose: treatment group B; MV-LASV low dose: treatment group A

Placebo OTHER

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.

MV-LASV low dose: treatment group A; Placebo: treatment group C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent obtained before any trial-related activities
• Healthy men or women aged 18 to ≤ 55 years on the day of consenting
• Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study
• All female participants of childbearing potential, defined as all woman physiologically capable of becoming pregnant, must have a negative pregnancy test at screening
• Willingness not to become pregnant or to father a child during the study up to 182 days after the first vaccination by practicing reliable methods of contraception
• Availability during the duration of the trial

You may not qualify if:

• Participation in another investigational clinical study (including exposure to an IMP or device) within four weeks before the screening visit or planned concurrent participation in another clinical study before study completion
• History of immunodeficiency, known HIV infection or current hepatitis B/C infection
• History of drug addiction including alcohol dependence within the last two years
• Inability or unwillingness to avoid intake of more than around 20g alcohol per day during 48 hours after each vaccination
• Vaccination within four weeks prior to first vaccination or planning to receive any non-study vaccine within 182 days after the first vaccination
• Prior receipt of any Lassa vaccine
• Recent infection within one week prior to Screening visit
• Blood donations including plasma donations, 90 days prior to Screening visit and anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until end of treatment period
• Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory, autoimmune or neurological diseases or clinically relevant abnormal laboratory values, that in the opinion of the investigator may interfere with the aim of the study
• History of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past five years or a history of any hematological malignancy
• Behavioral, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
• History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine
• History of or present hearing deficit
• Present thrombocytopenia and/or history of thrombocytopenia and/or bleeding disorders.
• History of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the volunteer

Sponsors & Collaborators

• Themis Bioscience GmbH: lead
• Coalition for Epidemic Preparedness Innovations: collaborator
• Harmony Clinical Research BVBA: collaborator
• Assign Data Management and Biostatistics GmbH: collaborator

Study Sites (1)

University of Antwerpen, Centre for the Evaluation of Vaccination (CEV)

Antwerp, Belgium

Location

Related Publications (1)

• 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.

  PMID: 36934733 RESULT

MeSH Terms

Conditions

Lassa Fever

Condition Hierarchy (Ancestors)

Arenaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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). All site personnel, Sponsor and participants will be unblinded. Then remaining participants will be randomized in a blinded manner to one of three Treatment Groups (A, B, C). Site personnel responsible for study medication handling, preparation and Administration will be unblinded, only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 13, 2019
• Study Start: September 26, 2019
• Primary Completion: March 13, 2020
• Study Completion: January 15, 2021
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)