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

January 21, 2022 updated by: Themis Bioscience GmbH

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.

Study Overview

Status

Completed

Detailed Description

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

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed informed consent obtained before any trial-related activities
  2. Healthy men or women aged 18 to ≤ 55 years on the day of consenting
  3. 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
  4. All female participants of childbearing potential, defined as all woman physiologically capable of becoming pregnant, must have a negative pregnancy test at screening
  5. 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
  6. Availability during the duration of the trial

Exclusion Criteria:

  1. 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
  2. History of immunodeficiency, known HIV infection or current hepatitis B/C infection
  3. History of drug addiction including alcohol dependence within the last two years
  4. Inability or unwillingness to avoid intake of more than around 20g alcohol per day during 48 hours after each vaccination
  5. Vaccination within four weeks prior to first vaccination or planning to receive any non-study vaccine within 182 days after the first vaccination
  6. Prior receipt of any Lassa vaccine
  7. Recent infection within one week prior to Screening visit
  8. 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
  9. 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
  10. 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
  11. 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
  12. 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
  13. History of or present hearing deficit
  14. Present thrombocytopenia and/or history of thrombocytopenia and/or bleeding disorders.
  15. History of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the volunteer
  16. Use of medication during two weeks before the first vaccination and throughout the study, which the investigator considers affecting the validity of the study, except hormonal contraception or hormonal replacement therapy in female participants (prior to taking any medication within 72 hours before study vaccination, the participant should consult the investigator)
  17. Use of immunosuppressive drugs like corticosteroids (excluding topical preparations) within 30 days prior to the first vaccination or anticipated use before completion of day 182
  18. Receipt of blood products or immunoglobulins within 120 days prior to the Screening Visit or anticipated receipt of any blood product or immunoglobulin before completion of day 182
  19. Pregnancy or lactation at screening or planning to become pregnant before completion of day 182
  20. Unreliable contraception Methods
  21. Persons in a direct relationship with the sponsor, an investigator or other study team members. Direct dependent relationships include close relatives (i.e. children, parents, partner/spouse, siblings) as well as employees of the clinical study site or the sponsor
  22. Individuals who are living and/or working with severely immunocompromised people, children under 15 months old or pregnant women
  23. Participants who travelled within one year prior to the first vaccination or plan to travel during the study to an endemic country
  24. A rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MV-LASV low dose: treatment group A
In total 24 participants will receive two low dose treatments with MV-LASV on day 0 and 28.
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.
Experimental: MV-LASV high dose: treatment group B
In total 24 participants will receive two high dose treatments with MV-LASV on day 0 and 28.
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.
Placebo Comparator: Placebo: treatment group C
In total 12 participants will receive placebo treatment on day 0 and 28.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of solicited and unsolicited Adverse Events (AEs)
Time Frame: 56 days
Rate of solicited and unsolicited adverse events (AEs) during the treatment period up to day 56
56 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Serious Adverse Events (SAEs)
Time Frame: 365 days
Rate of Serious Adverse Events (SAEs) during the treatment period up to study day 365
365 days
Cell-mediated immunity as confirmed by the presence of functional CD4+ and CD8+ T-cells
Time Frame: 56 days
Cell-mediated immunity specific for LASV up to day 56 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)
Time Frame: 56 days
Measurement of anti-LASV antibodies up to day 56 determined by Enzyme-linked Immunosorbent Assay (ELISA)
56 days
Quantification of functional, neutralizing antibodies via Virus Neutralization Tests (VNT)
Time Frame: 56 days
Quantification of functional, neutralizing antibodies on days 0, 28 and 56 via Virus Neutralization Tests (VNT)
56 days
Rate of abnormal laboratory parameters
Time Frame: 56 days
Rate of abnormal laboratory parameters until day 56
56 days
RT-qPCR Analysis of MV-LASV Viral Vector in Human Blood, Urine, and Saliva Samples
Time Frame: 42 days
Shedding of live recombinant virus up to day 42
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2019

Primary Completion (Actual)

March 13, 2020

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 21, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • V182-001
  • MV-LASV-101 (Other Identifier: Themisbio)
  • 2018-003647-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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