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Evaluation of the Safety and the Ability of a DNA Vaccine to Protect Against Dengue Disease

NCT01502358 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-11-04

No results posted yet for this study

Summary

The purpose of this study is to determine whether a new investigational dengue vaccine is safe, well-tolerated, and to see if an immune response against dengue disease will be generated.

Conditions

  • Dengue Disease
  • Dengue Fever

Interventions

BIOLOGICAL

Tetravalent Dengue Vaccine (TVDV)

Low dose delivered intramuscularly on Study Days 0, 30 and 90

BIOLOGICAL

Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose)

Low dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90

BIOLOGICAL

Tetravalent Dengue Vaccine TVDV with Vaxfectin® (High Dose)

High dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90

Sponsors & Collaborators

  • Vical

    collaborator INDUSTRY

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • Naval Medical Research Center

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Janine R Danko, MD · Naval Medical Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

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 NCT01502358 on ClinicalTrials.gov