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NCT04333459 · ClinicalTrials.gov registry record · Phase 2
Safety/Immunogenicity Hantaan Virus DNA Vaccine and Puumala Virus DNA Vaccine, For Prevention of HFRS
A Phase 2 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
NCT04333459: Completed Phase 2 study, sponsored by U.S. Army Medical Research and Development Command.
NCT04333459 is a Phase 2 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 132 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
NCT04333459, a Phase 2 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
Study Summary
A randomized 4 cohort study that is comparing the data collected during the earlier phase study and to determine if immunogenicity can be retained with a 1 mg dose of Hantaan DNA vaccine. The study is intended to substantiate the Phase 1 results with the 2 mg dose and to also determine if immunogenicity can be retained with a 1 mg dose (for HTNV DNA vaccine).
Primary Outcome
To assess the proportion of subjects in the high dose HTNV vaccine group (Group 1) that achieve immunologic seroconversion above the minimum target threshold of 80% seroconversion, after receiving 4 doses of vaccine using the PharmaJet Stratis ® device.
Interventions
- BIOLOGICAL Hantaan DNA Vaccine/Puumala DNA Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2021-08-23 |
| Est. Completion | 2024-10-15 |
| Phase | Phase 2 |
What the finished NCT04333459 record still lists
NCT04333459 is an interventional study that assigns participants to a tested intervention. The registered 132 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 1 intervention - of which Hantaan DNA Vaccine/Puumala DNA Vaccine is the first listed.
NCT04333459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04333459 about?
NCT04333459 is a clinical study titled "Safety/Immunogenicity Hantaan Virus DNA Vaccine and Puumala Virus DNA Vaccine, For Prevention of HFRS". A randomized 4 cohort study that is comparing the data collected during the earlier phase study and to determine if immunogenicity can be retained with a 1 mg dose of Hantaan DNA vaccine. The study is intended to substantiate the Phase 1 results with the 2 mg dose and to also determine if immunogeni...
What is the current status of trial NCT04333459?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2021-08-23. Estimated completion is 2024-10-15.
What interventions are being tested in trial NCT04333459?
The interventions under investigation include: Hantaan DNA Vaccine/Puumala DNA Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04333459?
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 NCT04333459's enrollment target sits among peer trials
132 539th of 2000 higher than 1,460 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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