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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: Completed Phase 2 study, sponsored by U.S. Army Medical Research and Development Command.
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, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT02116205 record still lists
NCT02116205 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02116205 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02116205's enrollment target sits among peer trials
130 543rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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