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NCT01502345 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines
A Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01502345: Completed Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
NCT01502345 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01502345, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study 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.
Primary Outcome
• The nature, frequency, and severity of local and systemic AEs or SAEs associated with TDS-IM-EP-based administration of HTNV and PUUV vaccines
Interventions
- BIOLOGICAL Vaccine/device combination for prevention of HFRS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
What the finished NCT01502345 record still lists
NCT01502345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which Vaccine/device combination for prevention of HFRS is the first listed.
NCT01502345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01502345 about?
NCT01502345 is a clinical study titled "Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines". 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...
What is the current status of trial NCT01502345?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2012-01. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01502345?
The interventions under investigation include: Vaccine/device combination for prevention of HFRS (BIOLOGICAL).
Who is sponsoring clinical trial NCT01502345?
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 NCT01502345's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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