drugset / Trial / NCT01502345
Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines
Phase 1
Completed
31 enrolled
U.S. Army Medical Research and Development Command
Ichor Medical Systems Incorporated · collabUS Army Medical Research Institute of Infectious Diseases · collabUnited States Army Medical Materiel Development Activity · collabWalter Reed Army Institute of Research (WRAIR) · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
The purpose of this study is: • To assess safety and tolerability of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), administered intramuscularly using a TDS-IM electroporation device Secondary: • To evaluate clinical immunogenicity of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), including an assessment of the acute procedure tolerability when administered with the TDS-IM electroporation.
Timeline
- Start
- 2012-01
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HTNV DNA Vaccine | Vaccine | 1 mg/ml | Intramuscular |
| Subject | HTNV DNA Vaccine | Vaccine | 2 mg/ml | Intramuscular |
| Subject | PUUV DNA Vaccine | Vaccine | 1 mg/ml | Intramuscular |
| Subject | PUUV DNA Vaccine | Vaccine | 2 mg/ml | Intramuscular |