Homologous Re-infection With Dengue 1 or Dengue 3

Dengue Clinical Trial

Official title: Phase One, Open Label, Homologous Reinfection With Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) or Dengue-3-Virus-Live Virus Human Challenge (DENV-3-LVHC) Virus Strains

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

The purpose of this study is to explore the clinical, virologic, and immunologic response of subjects following primary controlled dengue infection or following controlled homologous dengue reinfection.

SUNY Upstate Medical University completed three Dengue Human Infection Model studies, two with dengue 1 (DENV-1-LVHC), NCT 02372175 and NCT 03869060, and one with dengue 3 (DENV-3-LVHC), NCT 04298138 and investigators gained incredible knowledge about primary dengue infection. The investigators are moving to the next step in acquiring knowledge about the kinetics of homologous secondary infection in a controlled setting in this study. People who acquire natural dengue infection and who are subsequently infected by the same serotype are thought to have lifelong protection to that serotype.

Investigators will recruit up to 10 naive participants and infect them with either DENV-1-LVHC or DENV-3-LVHC with the same dose of virus as in previous studies. These participants will be followed over 6 months and reinfected with the same serotype originally received, i.e. homologous reinfection, and followed for another three months. Investigators will also recruit up to 10 participants who received either DENV-1-LVHC or DENV-3-LVHC in previous studies. These participants will be reinfected with the same serotype that was previously received and followed for 6 months. Investigators intend to collect similar information about the kinetics of homologous secondary infection as was collected in the studies following primary infection. ;

Related Conditions & MeSH terms

• Dengue

• NCT number: NCT05967455
• Study type: Interventional
• Source: State University of New York - Upstate Medical University
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 30, 2023
• Completion date: September 2024