Actively Recruiting
A Controlled Human Infection Model of Dengue
Led by Tan Tock Seng Hospital · Updated on 2026-02-17
5
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
Sponsors
T
Tan Tock Seng Hospital
Lead Sponsor
A
A*Star
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Controlled Human Infection Model of Dengue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Adults aged 21 to 45 years inclusive
- No known history of prior dengue, Zika, or other Orthoflavivirus infection
- No prior vaccination for dengue, yellow fever, Japanese encephalitis virus, or other Orthoflavivirus
- Suitable serology result from pre-screening
- Female participants must use contraception from 2 weeks before viral challenge to 1 month after final virus dose, with negative pregnancy tests before screening and inoculation
- Male participants must use contraception from viral challenge date for 1 month and agree not to donate sperm until 1 month after viral challenge
- Good health without clinically significant medical conditions as determined by medical history, physical exam, labs, ECG, and chest X-ray
- Willing and able to participate in the study
You will not qualify if you...
- History or evidence of significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
- History of active depression or anxiety with severe psychiatric comorbidities such as psychosis
- Behavioral, cognitive, or psychiatric conditions affecting understanding or cooperation
- History of drug or alcohol misuse
- History of anaphylaxis or severe allergic reactions to foods or drugs
- Family history of sudden cardiac or unexplained death in first-degree relative aged 50 years or less
- Body weight 45 kg or less and BMI less than 18 or greater than 30 kg/m2
- Inadequate venous access for blood sampling
- Clinically significant abnormalities in blood tests or urinalysis, including elevated HbA1C, positive HIV, or active hepatitis B or C
- Abnormal ECG findings as judged by investigator
- Receipt of live vaccine within 60 days or non-live vaccine within 30 days prior to viral challenge, or intention to receive vaccines before day 28 follow-up
- Previous receipt of any flavivirus vaccine
- Receipt of blood products or significant blood loss within 3 months before or planned within 3 months after viral challenge
- Use of investigational drugs within 3 months prior to viral challenge
- Use of systemic glucocorticoids or antivirals within 6 months prior to viral challenge
- Overuse of certain medications such as paracetamol or ibuprofen in the week before viral challenge
- Prior use of chemotherapy, immunoglobulins, cytotoxic or immunosuppressive drugs
- Mentally or legally incapacitated
- Females breastfeeding within 6 months before study or pregnant recently or positive pregnancy test
- First-degree relatives of research team members
- Any other investigator-determined unsuitability
- Presence of infection symptoms or fever over 37.9ºC at pre-challenge on day 0
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Centre for Infectious Diseases (NCID)
Singapore, Singapore
Actively Recruiting
Research Team
X
Xuan Ying Poh, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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