drugset / Trial / NCT02116205
Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever
Phase 2
Completed
130 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-groupDouble-blindPrevention
Summary
The purpose of this study is to compare the immune responses of two different doses (1.0 mg and 2.0 mg) and two different dosing schedules (two doses or three doses) of a mixed Hantaan virus (HTNV) and Puumala virus (PUUV) DNA vaccine in healthy participants. To maintain a blind, participants in the two-dose group will receive one dose of normal saline placebo. All of the groups will also receive a booster dose 6 months after first vaccination. The results will help to determine which dose and vaccination schedule will be best to move forward in the vaccine development process.
Timeline
- Start
- 2014-07-09
- Primary completion
- 2016-12-07
- Completion
- 2017-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HTNV/PUUV DNA vaccine | Vaccine | 1 mg | Intramuscular |
| Subject | HTNV/PUUV DNA vaccine | Vaccine | 2 mg | Intramuscular |