A Trial to Evaluate the Optimal Dose of MV-LASV (V182-001) (NCT04055454) | Clinical Trial Compass
CompletedPhase 1
A Trial to Evaluate the Optimal Dose of MV-LASV (V182-001)
Belgium60 participantsStarted 2019-09-26
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of solicited and unsolicited Adverse Events (AEs)
. 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