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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02860650 | A Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adults | PHASE1 | COMPLETED | 72 | — | — | Aug 1, 2016 | Jan 1, 2018 | Feb 5, 2018 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Group 1: AD26.Filo/MVA-BN-Filo or Placebo | EXPERIMENTAL | Participants will receive Ad26.Filo or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57. |
| Group 2: MVA-BN-Filo/AD26.Filo or Placebo | EXPERIMENTAL | Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 57. |
| Group 3: MVA-BN-Filo/AD26.Filo or Placebo | EXPERIMENTAL | Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 15. |
| Subset of Group 3: AD26.Filo or Placebo | EXPERIMENTAL | The first 8 participants in Group 3 who are willing to enroll in the subset for third vaccination, will receive a third vaccination at Day 92. Participants who previously received placebo will receive placebo a third time and participants who previously received MVA-BN-Filo/Ad26.Filo vaccination will receive Ad26.Filo as third vaccination. After enrollment of the 8 participants, the unblinded monitor and unblinded pharmacist will assess whether 7 participants who previously received MVA-BN-Filo/Ad26.Filo vaccination have been enrolled. If less than 7 participants of the active vaccine regimen have been enrolled, 2 additional participants will be enrolled. If at least 7 participants of the active vaccine regimen have been enrolled, no further will be enrolled. The aim is to enroll 7 or 8 participants who will receive Ad26.Filo as third vaccination. |
| Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo | EXPERIMENTAL | Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57. |
| Name | Type | Description |
|---|---|---|
| Ad26.Filo | BIOLOGICAL | Ad26.Filo intramuscular (IM) injection at a dose of 9\*10\^10 viral particles (vp). |
| MVA-BN-Filo | BIOLOGICAL | MVA-BN-Filo intramuscular (IM) injection at a dose of 5\*10\^8 infectious units (Inf U). |
| Ad26.ZEBOV | BIOLOGICAL | Ad26.ZEBOV intramuscular (IM) injection at a dose of 5\*10\^10 vp. |
| Placebo | BIOLOGICAL | IM injection of 0.9 percent saline. |
Inclusion Criteria: * Body mass index (BMI) of greater than or equal to (\>=) 18.5 and less than (\<) 35.0 kilogram per square meter (kg/m\^2) * Healthy on the basis of physical examination, medical history, and the investigator's clinical judgment * All women of childbearing potential must have a ...