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Safety, Virological and Immunological Assessment of the Controlled Dengue Human Infection Model in Dengue-Immune Participants in Thailand (DHIT-Immune)

Study acronym: DHIT-Immune
StatusNot Yet Recruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 3, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
rDEN2Δ30-7169 is a dengue challenge strain that previously reports its viremia induction effect in participants with minimal symptoms in US flavivirus naïve participants. Moreover, preliminary result of five Thai dengue naïve participants from previous project (registered number NCT05476757) demonstrated 100% viremia status without severe adverse event after 60 days post-virus challenge. However, result from previous project may not fully represent the clinical manifestation and immunological responses of major population of endemic areas, where most people in endemic area have dengue immune status. Therefore, this controlled human infection model protocol proposes to challenge the attenuated virus in 12 dengue-immune participants recruited from Bangkok metropolitan area, Thailand. We aim to assess the safety, viremia, NS1 antigenemia profile, and immunogenicity of the challenge virus in the dengue immune participants. After finish safety assessment, all participants will be vaccinated with a full course of dengue vaccines to prevent recurrent dengue infection. Immunological responses after vaccination will be also evaluated the vaccine efficacy. Our expected outcomes are all participants present viremia profiles after virus challenge without serious adverse events (SAE). The exploratory profiles include assesment of immune profiles and parameters comparison with the other dengue challenge study.
Trial Details
NCT Number NCT06908018
Lead Sponsor Mahidol University
Collaborators: National Institutes of Health (NIH), Johns Hopkins University
Conditions Safety Issues, Dengue, Viremia, Immune-related Adverse Event
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov