Homologous Re-infection With Dengue 1 or Dengue 3

NCT05967455 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-11-13

No results posted yet for this study

Summary

Previous studies with one dengue infection in a controlled environment at Upstate generated data that has been important in understanding the clinical signs and symptoms and how a person's body reacts to dengue infection over time. This has helped investigators compare what is seen in the clinic to what is seen in areas where dengue is prevalent. The investigators want to collect similar information when a person gets the same dengue twice in a controlled environment with the hope that this will lead them to a better understanding of the disease.

New participants

* will receive one inoculation of dengue and then return to the clinic or be contacted by phone over 6 months;
* will receive a second inoculation after 6 months and return to the clinic or be contacted by phone for three more months;
* will collect saliva at home;
* will allow the study team to collect blood and saliva at the clinic visits.

Participants who have been in previous dengue inoculation studies at SUNY Upstate

* will receive one inoculation of dengue and then return to the clinic or be contacted by phone over 6 months;
* will collect saliva at home;
* will allow the study team to collect blood and saliva at the clinic visits.

All participants will be seen in the clinic every other day for the first three weeks after any inoculation.

Conditions

  • Dengue

Interventions

BIOLOGICAL

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

Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5

BIOLOGICAL

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

Dengue subtype 3 Challenge Virus (DENV-3) strain CH53489

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED
  • Walter Reed Army Institute of Research (WRAIR)

    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

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2024-08-26
Completion
2024-08-26
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 NCT05967455 on ClinicalTrials.gov