CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
HTNV/PUUV DNA vaccine +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02116205
NCT02116205Phase 2Completed
CompareCT.gov

A Phase 2a Double-Blind, Dose-optimizing Study to Evaluate the Immunogenicity of Hantaan/Puumala Virus DNA Vaccine Administered to Healthy Adult Volunteers by Electroporation for Prevention of Hemorrhagic Fever With Renal Syndrome

U.S. Army Medical Research and Development Command·interventional·Posted Apr 16, 2014·Updated Feb 12, 2021

In Brief

A Phase 2 clinical trial evaluating HTNV/PUUV DNA vaccine, Placebo, and 1 other intervention for Hemorrhagic Fever With Renal Syndrome. Completed, enrolled 130 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhagic Fever With Renal Syndrome
CountriesUnited States
CollaboratorsWalter Reed Army Institute of Research (WRAIR), Ichor Medical Systems Incorporated, United States Army Medical Materiel Development Activity, US Army Medical Research Institute of Infectious Diseases

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 16, 2014
Enrollment StartJul 9, 2014
Primary CompletionDec 7, 2016
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.2 years ago

Interventions

HTNV/PUUV DNA vaccinebiological

HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)

Placebobiological

0.9% sodium chloride

TriGrid Delivery System (TDS)device

The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses