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NCT02116205 · ClinicalTrials.gov registry record · Phase 2
Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever
A Phase 2 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
NCT02116205 is a Phase 2 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 130 participants.
The verdict
NCT02116205, a Phase 2 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL HTNV/PUUV DNA vaccine
- DEVICE TriGrid Delivery System (TDS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2014-07-09 |
| Est. Completion | 2017-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02116205
The ClinicalTrials.gov registry entry for NCT02116205 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is U.S. Army Medical Research and Development Command, which has 77 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02116205 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02116205 about?
NCT02116205 is a clinical study titled "Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever". 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...
What is the current status of trial NCT02116205?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2014-07-09. Estimated completion is 2017-07.
What interventions are being tested in trial NCT02116205?
The interventions under investigation include: Placebo (BIOLOGICAL), HTNV/PUUV DNA vaccine (BIOLOGICAL), TriGrid Delivery System (TDS) (DEVICE).
Who is sponsoring clinical trial NCT02116205?
This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.
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