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Dengue 3 Human Infection Model (DENV-3)

NCT04298138 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-04-11

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. This study will examine the safety and effectiveness of the Dengue 3 Live Virus Human Challenge (DENV-3-LVHC) product and assess the ability of this virus strain to elicit an uncomplicated dengue-like illness.

Conditions

  • Dengue

Interventions

BIOLOGICAL

Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC)

Dengue subtype 3 Challenge Virus (DENV-3) strain CH53489 administered as a single injection.

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • State University of New York - Upstate Medical University

    lead OTHER

Principal Investigators

  • Stephen J Thomas, MD · State University of New York, Upstate Medical University (SUNY-UMU)

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2021-12-14
Completion
2021-12-14
FDA Drug
Yes

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 NCT04298138 on ClinicalTrials.gov