Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04055454 | A Trial to Evaluate the Optimal Dose of MV-LASV (V182-001) | PHASE1 | COMPLETED | 60 | — | — | Sep 26, 2019 | Jan 15, 2021 | Jul 11, 2025 | 1 | Belgium |
Rate of solicited and unsolicited adverse events (AEs) during the treatment period up to day 56
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Placebo: treatment group C | PLACEBO_COMPARATOR | In total 12 participants will receive placebo treatment on day 0 and 28. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
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 ...