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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03883113 | Efficacy of MVA-NP+M1 in the Influenza H3N2 Human Challenge Model | PHASE2 | COMPLETED | 145 | — | — | Jun 3, 2019 | Apr 17, 2020 | Mar 18, 2021 | 1 | Belgium |
Measure of nasopharyngeal viral shedding during challenge; recorded as viral area under curve (vAUC) as determined by quantitative real time polymerase chain reaction (qRT-PCR). vAUC is calculated by plotting the log viral particles number/ml for each time point against time and is using the trapezoidal rule.
| Arm | Type | Description |
|---|---|---|
| MVA-NP+M1 & H3N2 Challenge Virus | EXPERIMENTAL | Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10\^8 pfu.); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml) |
| Saline Placebo & H3N2 Challenge Virus | PLACEBO_COMPARATOR | Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml) |
| Name | Type | Description |
|---|---|---|
| MVA-NP+M1 | BIOLOGICAL | Trial Vaccine |
| Saline | BIOLOGICAL | Sodium Chloride Placebo |
| H3N2 (A/Belgium/2417/2015) | BIOLOGICAL | Challenge Agent |
Inclusion Criteria: * Healthy males and females aged ≥18 and ≤55 years of age at the point of enrolment. * Non-smokers or those who stopped smoking ≥ 3 months prior to screening 1 visit. * Willingness to remain in isolation for the duration of the study. * A female participant is eligible for this ...