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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 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.

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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.

Interventions

  • BIOLOGICAL Vaccine/device combination for prevention of HFRS

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2012-01
Est. Completion 2013-01
Phase Phase 1

What the Registry Record Tells You About NCT01502345

The ClinicalTrials.gov registry entry for NCT01502345 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 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 1 intervention - of which Vaccine/device combination for prevention of HFRS is the first listed.

NCT01502345 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.