A Controlled Human Infection Model of Dengue (NCT07412483) | Clinical Trial Compass
RecruitingNot Applicable
A Controlled Human Infection Model of Dengue
Singapore5 participantsStarted 2026-03
Plain-language summary
This study aims to conduct a safe human infection challenge using an attenuated serotype DEN3 dengue virus in adult volunteers. The clinical, viral and immune response characteristics of the model will be analysed to understand the pathophysiology of dengue fever. This data will be used to inform future studies, including a planned follow up study (DEN-CHIM-02) which will investigate the efficacy of an investigational dengue vaccine at protecting against DEN3 infection.
Study conditions that result in a safe, reproducible infection in ≥80% of research participants (attack rate) with the DEN3 challenge agent have been identified during studies conducted by our collaborators in the US. This includes the inoculum dose, safety monitoring, and necessary participant pre-screening to exclude prior Orthoflavivrus infection or vaccinations.
Study objectives are to:
1. Establish in seronegative volunteers in Singapore a safe DENV controlled human infection (CHI) model, with an infection rate of ≥80%, suitable for future studies of interventions.
2. Characterise the clinical, haematological and virological response following controlled inoculation of the attenuated DEN3 challenge agent.
3. Conduct deep immunophenotyping to understand the cellular, humoral and innate immune response to dengue infection.
4. Explore the longitudinal immune response in the 3 years after challenge, including following subsequent dengue vaccination.
Who can participate
Age range21 Years – 45 Years
SexALL
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Inclusion criteria
✓. An informed consent form (ICF) has been signed and dated by the participant, an investigator, and a witness
✓. Adult, aged between 21 and 45 years, inclusive (at the time of consent)
✓. No known history of prior dengue, zika or other Orthoflavivirus infection
✓. No history of prior dengue, yellow fever, Japanese encephalitis virus, or other Orthoflavivirus vaccination
✓. Sero-suitable based on the pre-screening serology result
✓. a Female participants must be willing and able to use contraception from 2 weeks before the scheduled date of viral challenge until 1 month after receipt of the final dose of study virus. Negative urine pregnancy tests will be required at screening, and on admission to the quarantine unit a negative serum beta human chorionic gonadotropin (β-hCG) is required prior to inoculation.
Exclusion criteria
✕. History or evidence of any clinically significant or currently active neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease.
What they're measuring
1
Incidence of unsolicited Adverse Events (AEs) [Safety]
Timeframe: From day of viral challenge (Day 0) to Day 28 follow-up visit
2
Severity of unsolicited AEs [Safety]
Timeframe: From day of viral challenge (Day 0) to Day 28 follow-up visit
3
Incidence of Serious Adverse Events (SAEs) related to the viral challenge [Safety]
Timeframe: Day of viral challenge (Day 0) to Day 28 follow-up visit
4
Number of participants with lab confirmed infection [Infectivity]
Timeframe: From day of viral challenge (Day 0) to discharge from quarantine (Day 10).
. History of active depression and/or anxiety with associated severe psychiatric comorbidities, for example psychosis.
✕. Behavioural, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol.
✕. Significant history or presence of drug or alcohol misuse
✕. History of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the PI.
✕. Family history of 1st degree relative aged 50 years or less with sudden cardiac or unexplained death
✕. A total body weight of ≤ 45kg and a Body Mass Index (BMI) ≤18 kg/m2 and ≥30 kg/m2.
✕. Venous access deemed inadequate for the phlebotomy demands of the study.