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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02116205 | Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever | PHASE2 | COMPLETED | 130 | — | — | Jul 9, 2014 | Jul 1, 2017 | Feb 12, 2021 | 1 | United States |
The primary endpoint will be to determine the seroconversion rates of the vaccines. Seroconversion is defined as production of neutralizing antibody titers measured using a pseudovirion neutralization assay (PsVNA). A PsVNA50 titer ≥ 20 is considered positive. Sera were collected on Days 0, 28, 56, 84, 140, 168, 196, 252, 365 and evaluated for the presence of neutralizing antibodies using PsVNA50. Percentages for seroconversion are based on the number of subjects presenting non-missing data.
| Arm | Type | Description |
|---|---|---|
| Vaccine + Placebo at 1.0 mg | EXPERIMENTAL | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28. |
| Vaccine at 1.0 mg | EXPERIMENTAL | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. |
| Vaccine + Placebo at 2.0 mg | EXPERIMENTAL | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28. |
| Vaccine at 2.0 mg | EXPERIMENTAL | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. |
| Name | Type | Description |
|---|---|---|
| HTNV/PUUV DNA vaccine | BIOLOGICAL | HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) |
| Placebo | BIOLOGICAL | 0.9% sodium chloride |
| TriGrid Delivery System (TDS) | DEVICE | The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses |
Inclusion Criteria: * Healthy adult male or non-pregnant, non-lactating female, ages 18-49 (inclusive) at the time of screening * Have provided written informed consent before screening * Free of clinically significant health problems, as determined by pertinent medical history and clinical examina...