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A Single-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Hantaan Puumala Virus DNA Vaccine

NCT02776761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-02-16

No results posted yet for this study

Summary

This is a single-center, randomized, single-blinded study of the Hantaan virus HTNV DNA vaccine alone, Puumala virus PUUV DNA vaccine alone, and mixed Hantaan/Puumala HTNV/PUUV DNA vaccines delivered intramuscularly IM by the needle-free PharmaJet Stratus DSJI device.

Conditions

  • Hantaan Virus

Interventions

BIOLOGICAL

Hantaan Vaccine:

DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline

BIOLOGICAL

Puumala Vaccine

DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline

BIOLOGICAL

Hantaan/Puumala Vaccine

DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Kristopher Paolino, MD · Walter Reed Army Institute of Research (WRAIR)

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
2016-08-30
Primary Completion
2017-09-27
Completion
2017-09-27

Countries

  • United States

Study Locations

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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 NCT02776761 on ClinicalTrials.gov