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Assessment of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain

NCT02372175 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2019-07-15

No results posted yet for this study

Summary

To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to develop an appropriate challenge model. To this end, this first-in-human study will examine the safety and effectiveness of the Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) product and assess the ability of this virus strain to elicit an uncomplicated dengue-like illness.

Conditions

  • Dengue

Interventions

BIOLOGICAL

Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)

Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5 administered as a single injection.

Sponsors & Collaborators

  • State University of New York - Upstate Medical University

    collaborator OTHER

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Timothy P Endy, MD, MPH · State University of New York, Upstate Medical University (SUNY-UMU)

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-06-28
Completion
2019-06-28

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 NCT02372175 on ClinicalTrials.gov