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New treatment option for Dengue
Official title A Controlled Human Infection Model of Dengue
ClinicalTrials.gov ID: NCT07412483
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- ) that would interfere with subject safety, as defined by medical history, physical examination and routine laboratory tests, ECG, and Chest X-Ray...
- History or evidence of any clinically significant or currently active neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal...
- 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...
- 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.
See the full eligibility 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...
- ) that would interfere with subject safety, as defined by medical history, physical examination and routine laboratory tests, ECG, and Chest X-Ray and determined by the Investigator at an admission evaluation. 8 Willing...
- History or evidence of any clinically significant or currently active neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease.
- 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.
- Any clinically significant abnormal finding on screening biochemistry, haematology and microbiology blood tests or urinalysis apart from minor deviations which are clinically acceptable and approved by the investigator...
- Elevated HbA1C
- Positive HIV, active/chronic hepatitis B or hepatitis C test. 10 Twelve-lead ECG recording with clinically relevant abnormalities as judged by the study investigator. 11 Receipt of a live vaccine within 60 days prior to...
- Receipt of any investigational drug within 3 months prior to the planned date of viral challenge
- Receipt of systemic (intravenous and/or oral) glucocorticoids or systemic antiviral drugs within 6 months prior to the planned date of viral challenge.
- Over the counter medications (e.g., paracetamol or ibuprofen) where the dose taken over the preceding 7 days prior to the planned date of viral challenge had exceeded the maximum permissible 24-hour dose (e.g., \>4g per...
- Participants who have received any systemic chemotherapy agent, immunoglobulins, or other cytotoxic or immunosuppressive drugs at any time. 15 Participant is mentally or legally incapacitated in the opinion of the...
- Are breastfeeding within 6 months of study commencement, or
- Had been pregnant within 6 months prior to the study, or
- Had a positive pregnancy test at any point during screening or prior to inoculation with challenge virus 17 Anyone who is first degree related to anyone who is a delegated member of the research team. 18 Any other...
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.