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 range18 Years – 55 Years
SexALL
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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
✕. 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
✕
What they're measuring
1
Rate of solicited and unsolicited Adverse Events (AEs)
. 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