Lassa Virus InfectionPhase 1NCT04055454
A Trial to Evaluate the Optimal Dose of MV-LASV (V182-001)
A Phase 1 study testing MV-LASV in people with Lassa Virus Infection, run by Themis Bioscience GmbH at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Lassa Virus Infection
- What is being tested?
- MV-LASV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Sep 2019to 15 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
- 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)
- 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
- 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
- Pregnancy or lactation at screening or planning to become pregnant before completion of day 182
- Unreliable contraception Methods
- 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
- Individuals who are living and/or working with severely immunocompromised people, children under 15 months old or pregnant women
- Participants who travelled within one year prior to the first vaccination or plan to travel during the study to an endemic country
- A rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University of Antwerpen, Centre for the Evaluation of Vaccination (CEV)
Antwerp
About this study
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.
Read the 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.
- Conditions
- Lassa Virus Infection
- Being tested
- MV-LASV, Placebo
- Keywords
- Lassa Virus Infection, Prevention, Vaccine, Phase 1, Lassa Fever
- Medical subject headings
- Lassa Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MV-LASVBiological
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: MV-LASV |
| Placebo: treatment group C | Placebo comparator | In total 12 participants will receive placebo treatment on day 0 and 28. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of solicited and unsolicited Adverse Events (AEs)
Rate of solicited and unsolicited adverse events (AEs) during the treatment period up to day 56
Measured: 56 days
Secondary outcomes (6)
Rate of Serious Adverse Events (SAEs)
Rate of Serious Adverse Events (SAEs) during the treatment period up to study day 365
Measured: 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
Measured: 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)
Measured: 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)
Measured: 56 days
Rate of abnormal laboratory parameters
Rate of abnormal laboratory parameters until day 56
Measured: 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
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start26 Sep 2019
- Primary completion13 Mar 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lassa Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Themis Bioscience GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Coalition for Epidemic Preparedness Innovations, Harmony Clinical Research BVBA, Assign Data Management and Biostatistics GmbH
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055454
- Sponsor's protocol ID
- V182-001
- Other IDs
- MV-LASV-101, 2018-003647-40, 2018
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2019
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 36934733
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04055454
- Acronym / sponsor ID
- V182-001
- Conditions
- Lassa Virus Infection
- Keywords
- Lassa Virus Infection, Prevention, Vaccine, Phase 1, Lassa Fever
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Themis Bioscience GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Coalition for Epidemic Preparedness Innovations, Harmony Clinical Research BVBA, Assign Data Management and Biostatistics GmbH
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MV-LASV low dose: treatment group A | Experimental | Biological: MV-LASV, Other: PlaceboIn total 24 participants will receive two low dose treatments with MV-LASV on day 0 and 28. |
| MV-LASV high dose: treatment group B | Experimental | Biological: MV-LASVIn total 24 participants will receive two high dose treatments with MV-LASV on day 0 and 28. |
| Placebo: treatment group C | Placebo comparator | Other: PlaceboIn total 12 participants will receive placebo treatment on day 0 and 28. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MV-LASVThe 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. | Biological | MV-LASV high dose: treatment group B, MV-LASV low dose: treatment group A |
| PlaceboA 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. | Other | MV-LASV low dose: treatment group A, Placebo: treatment group C |
Primary outcome
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
6 secondary outcomes
Rate of Serious Adverse Events (SAEs)
Time frame: 365 days
Cell-mediated immunity 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)
Time frame: 56 days
Quantification of functional, neutralizing antibodies via Virus Neutralization Tests (VNT)
Time frame: 56 days
Rate of abnormal laboratory parameters
Time frame: 56 days
RT-qPCR Analysis of MV-LASV Viral Vector in Human Blood, Urine, and Saliva Samples
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Results publication: PubMed 36934733Tschismarov 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.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MV-LASV in people with Lassa Virus Infection, run by Themis Bioscience GmbH at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of solicited and unsolicited Adverse Events (AEs) (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04055454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.