A Controlled Human Infection Model of Dengue
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, includ
| Condition(s) | Dengue |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 prio |
| Who can participate | Inclusion Criteria: 1. An informed consent form (ICF) has been signed and dated by the participant, an investigator, and a witness 2. Adult, aged between 21 and 45 years, inclusive (at the time of consent) 3. No known history of prior dengue, zika or other Orthoflavivirus infection 4. No history of prior dengue, yellow fever, Japanese encephalitis virus, or other Orthoflavivirus vaccination 5. Sero-suitable based on the pre-screening serology result 6. 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 |
| Ages | 21 Years to 45 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Tan Tock Seng Hospital |
| Locations | Singapore, Singapore |
| Start date | 2026-03 |
| NCT ID | NCT07412483 |
| Official listing | https://clinicaltrials.gov/study/NCT07412483 |