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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02543567 | A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants | PHASE3 | COMPLETED | 525 | — | — | Sep 21, 2015 | Nov 29, 2016 | May 25, 2025 | 6 | United States |
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Ad26.ZEBOV 5\*10\^10 viral particles (vp) single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 1\*10\^8 Infectious Unit \[Inf. U.\] single dose IM injection on Day 57 |
| Group 2 | EXPERIMENTAL | Ad26.ZEBOV 2\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U single dose IM injection on Day 57 |
| Group 3 | EXPERIMENTAL | Ad26.ZEBOV 0.8\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U. single dose IM injection on Day 57 |
| Group 4 | EXPERIMENTAL | Participants will receive intramuscular (IM) injection of Placebo (0.9% saline) once on Day 1 and Day 57 |
| Name | Type | Description |
|---|---|---|
| Ad26.ZEBOV 5*10^10 viral particles (vp) | BIOLOGICAL | Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1 |
| Ad26.ZEBOV 2*10^10 (vp) | BIOLOGICAL | Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 2\*10\^10 viral particles on Day 1 |
| Ad26.ZEBOV 0.8*10^10 (vp) | BIOLOGICAL | Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 0.8\*10\^10 viral particles on Day 1 |
| MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] | BIOLOGICAL | MVA-BN-Filo- live replication incompetent vaccine, IM injection of 1\*10\^8 Infectious Unit \[Inf. U.\] once on Day 57 |
| MVA-BN-Filo 5*10^7 Inf. U. | BIOLOGICAL | MVA-BN-Filo- live replication incompetent vaccine, IM injection of 5\*10\^7 Inf. U. once on Day 57 |
| Placebo | BIOLOGICAL | One 0.5 ml IM injection of 0.9% saline administered once on Day 1 and Day 57 |
Inclusion criteria : * Must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening * Must be healthy on the basis of clinical laboratory tests performed at Screening * Before randomizat...