NCT06908018

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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Safety Issues
• Dengue
• Viremia
• Immune-related Adverse Event

Interventions

Type	Name	Description
BIOLOGICAL	rDEN2Δ30-7169	rDEN2Δ30-7169 is a recombinat virus that could induce viremia and immunological responses with out serious adverse effect. The virus will be challenged after participants screening and consent for hospitalization. After virus challenge, the virological, immunological and clinical manifestation will be recorded and analyzed for the result from day 0-60 post-virus challenge.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-06-01
• Completion: 2028-09-01
• First posted: 2025-04-03
• Last updated: 2025-04-03

Regulatory

• FDA-regulated drug study