Status:
NOT_YET_RECRUITING
Safety, Virological and Immunological Assessment of the Controlled Dengue Human Infection Model in Dengue-Immune Participants in Thailand (DHIT-Immune)
Lead Sponsor:
Mahidol University
Collaborating Sponsors:
National Institutes of Health (NIH)
Johns Hopkins University
Conditions:
Safety Issues
Dengue
Eligibility:
All Genders
18-40 years
Phase:
EARLY_PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Thai healthy volunteers, aged between 18 to 40 years old, weight is greater than or equal to 50 kg and have Thai language literacy.
- Have not given blood donation in the past 3 months.
- Education: high school diploma or above
- Positive dengue-immune status against DENV-1 and/or DENV-3 and/or DENV-4 with naive DENV-2 status by the standard FRNT 50% (FRNT50) as follows: FRNT50 titer against
- DENV1 ≥ 1:5 and/or
- DENV3 ≥ 1:5 and/or
- DENV4 ≥ 1:5 with
- DENV2 ≤ 1:16
- Willingness to participate in the study as evidenced by signing the informed consent document.
- Female participants of childbearing potential should be agreed to either abstinence or use at least one primary form of contraception from the time of screening for rDEN2Δ30-7169 administration until 1 month after complete course of Dengue vaccination (Study Day 298).
Exclusion
- For female participants: Currently pregnant, as determined by positive urine human choriogonadotropin (HCG) test or breast-feeding, and given birth or abortion within 6 months.
- History of previous acute undifferentiated febrile illness leading to hospitalization in the past 3 months.
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the subject's ability to understand and cooperate with the requirements of the study protocol.
- Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by subject history.
- History of a severe allergic reaction or anaphylaxis.
- Severe asthma (emergency room visit or hospitalization within the last 6 months).
- Any known immunodeficiency syndrome.
- Having any pre-existing medical conditions consist of thrombocytopenia, autoimmune disease and cancer based on history, physical examination, and/or laboratory studies.
- Current use of anticoagulant medications (this includes anti-platelet medication such as aspirin or non-steroidal anti-inflammatory medications).
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as ≥ 10 mg of a prednisone equivalent per day for ≥ 14 days.
- Asplenia
- Receipt of any vaccine within 28 days or a killed vaccine within 14 days prior to receiving virus administration, or anticipated receipt of any vaccine during the 28 days following rDEN2Δ30-7169 administration.
- Has an obvious history of receiving any type of dengue vaccine or has previously participated in dengue vaccine research.
- Receipt of blood products within the past 6 months, including transfusions or immunoglobulin, or anticipated receipt of any blood products or immunoglobulin during the 28 days following rDEN2Δ30-7169 administration.
- History of allergy to Qdenga vaccine or any components of the vaccine.
- Previous episode of severe dengue infection defined by WHO 2009
- Screening laboratory values of Grade 1 or above (as defined in this protocol) for ANC (\<750 /mm3), Platelet (\<100,000 /mm3), PT (\> 1.25 x ULN), APTT (\> 1.66 x ULN), ALT (\>2.5 x ULN) and plasma creatinine (\> 1.3 x ULN OR Increase to \>1.3 x participant's baseline).
- A participant with hemoglobin level less than 10 g/dL at initial screening.
- Body temperature is greater than or equal to 38.0 °C (Oral)
- HIV infection, as indicated by anti-HIV screening assays.
- Hepatitis C virus (HCV) infection, as indicated by anti-HCV screening assays.
- Hepatitis B virus (HBV) infection, as indicated by hepatitis B surface antigen (HBsAg) and/or anti-HBc screening.
- Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, or would render the subject unable to comply with the protocol.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06908018
Start Date
September 1 2025
End Date
September 1 2028
Last Update
April 3 2025
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