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Dengue 3 Human Infection Model (DENV-3) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Dengue 3 Human Infection Model (DENV-3)

Phase One, Open Label Assessment of a Dengue-3-Virus-Live Virus Human Challenge - (DENV-3-LVHC) Virus Strain

NCT04298138•State University of New York - Upstate Medical University

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.

Detailed Description

Healthy subjects between 18 and 45 years old will be inoculated with Dengue 3 Live Virus Human Challenge (DENV-3-LVHC) in a dose ranging study. Subjects will be closely monitored for the first 28 days with continued follow up through 6 months. Clinical and laboratory parameters, viremia and antibody levels will be assessed. The goal is to determine the dose that produces uncomplicated dengue-like illness.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age 18-45 at the time of consent
•2. Ability and willingness to sign informed consent
•3. Passing score on comprehension test of at least 75%, with up to 3 attempts
•4. Available for the study period
•5. Willing to use contraception for the duration of the study
•6. Provide consent for release of medical history records from primary care physician, college or university, urgent care or emergency room visit

Exclusion Criteria

•1. Female: pregnant or lactating
•2. Heavy menstrual bleeding within the last 6 months- menstrual periods lasting longer than 6 days, or requiring 5 or more pads or tampons per day.
•3. Female subjects using an intrauterine device (IUD) or Mirena®
•4. Female subjects with fibroids or uterine polyps, endometriosis, adenomyosis, and uterine scarring (e.g., after D\&C)
•5. Blood tests confirming infection with human immunodeficiency virus- 1 (HIV-1), hepatitis C, hepatitis B (assessed by HbsAg) virus, or positive antibodies to the flaviviruses (FV) dengue, West Nile, Yellow Fever, Japanese encephalitis, or Zika.
•6. Active Diabetes or active peptic ulcer disease (PUD)
•7. Chronic obstructive pulmonary disease (COPD) or coronary artery disease (CAD)
•8. Known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
•9. Current, or a history of, auto-immune disease
•10. History of Guillain-Barré syndrome (GBS)
+19 more criteria

Locations (1)

State University of New York, Upstate Medical University (SUNY-UMU)

Syracuse, New York, United States

Key Dates

Start Date

August 3, 2020

Primary Completion Date

December 14, 2021

Completion Date

December 14, 2021

Last Updated

April 11, 2024

Enrollment

ACTUAL participants

Conditions

Dengue

Interventions

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

BIOLOGICAL

Dengvaxia US Pregnancy Registry

NCT04486638

Dengue Virus Infection

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RECRUITING

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection

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RECRUITINGPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dengue 3 Human Infection Model (DENV-3)

Inclusion Criteria

Exclusion Criteria

Dengvaxia US Pregnancy Registry

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection

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