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HTNV/PUUV DNA vaccine · 1 trial · 1 indication
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...
HTNV/PUUV DNA vaccine is an investigational vaccine being studied for the prevention of Hemorrhagic Fever With Renal Syndrome, a condition caused by Hantaan and Puumala viruses. It is designed to generate an immune response against these viruses. The vaccine is currently in clinical development and has not been approved by regulatory authorities.
HTNV/PUUV DNA vaccine is being developed by United Therapeutics Corporation, a publicly traded company listed on NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity for the prevention of Hemorrhagic Fever With Renal Syndrome.
HTNV/PUUV DNA vaccine is in Phase 2 clinical development. A Phase 2a study has been completed, which evaluated the vaccine's immunogenicity for the prevention of Hemorrhagic Fever With Renal Syndrome. The vaccine remains investigational and has not received regulatory approval for commercial use.
HTNV/PUUV DNA vaccine has been studied in one completed clinical trial, identified as NCT02116205. This was a Phase 2a immunogenicity study conducted in the United States with 130 participants, including healthy volunteers aged 18 years and older. The trial was randomized, double-blind, and controlled, with biomarker selection.
Yes, HTNV/PUUV DNA vaccine is a DNA vaccine targeting Hantaan and Puumala viruses, which cause Hemorrhagic Fever With Renal Syndrome. The vaccine is designed to elicit an immune response against these viruses. It is being developed by United Therapeutics Corporation and has completed a Phase 2a clinical trial.