MedTrace Logo

Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines

NCT01502345 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2013-01-31

No results posted yet for this 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.

Conditions

  • Hemorrhagic Fever With Renal Syndrome

Interventions

BIOLOGICAL

Vaccine/device combination for prevention of HFRS

PUUV DNA Vaccine, 2.0mg/ml TDS-IM injection HTNV DNA Vaccine, 2.0 mg/ml TDS-IM injection HTNV + PUUV Vaccine mixture, 1.0mg/mL + 1.0mg/ml TDS-IM injection

Sponsors & Collaborators

  • US Army Medical Research Institute of Infectious Diseases

    collaborator FED

  • United States Army Medical Materiel Development Activity

    collaborator FED

  • Ichor Medical Systems Incorporated

    collaborator INDUSTRY

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • James E Moon, MD · WRAIR, Clinical Trials Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01502345 on ClinicalTrials.gov