Safety IssuesEarly Phase 1DHIT-ImmuneNCT06908018
Safety, Virological and Immunological Assessment of the Controlled Dengue Human Infection Model in Dengue-Immune Participants in Thailand (DHIT-Immune)
A Early Phase 1 study testing rDEN2Δ30-7169 in people with Safety Issues and Dengue, run by Mahidol University.
Trial 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 of five Thai dengue naïve participants from previous project (registered number NCT05476757) demonstrated 100% viremia… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Dengue, Viremia
- What is being tested?
- rDEN2Δ30-7169
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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 of five Thai dengue naïve participants from previous project (registered number NCT05476757) demonstrated 100% viremia status without severe adverse event after 60 days post-virus challenge. However, result from previous project may not fully represent the clinical manifestation and immunological responses of major population of endemic areas, where most people in endemic area have dengue immune status. Therefore, this controlled human infection model protocol proposes to challenge the attenuated virus in 12 dengue-immune participants recruited from Bangkok metropolitan area, Thailand. We aim to assess the safety, viremia, NS1 antigenemia profile, and immunogenicity of the challenge virus in the dengue immune participants. After finish safety assessment, all participants will be vaccinated with a full course of dengue vaccines to prevent recurrent dengue infection. Immunological responses after vaccination will be also evaluated the vaccine efficacy.
Our expected outcomes are all participants present viremia profiles after virus challenge without serious adverse events (SAE). The exploratory profiles include assesment of immune profiles and parameters comparison with the other dengue challenge study.
- Conditions
- Safety Issues, Dengue, Viremia, Immune-related Adverse Event
- Being tested
- rDEN2Δ30-7169
- Medical subject headings
- Dengue, Viremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rDEN2Δ30-7169Biological
rDEN2Δ30-7169 is a recombinat virus that could induce viremia and immunological responses with out serious adverse effect. The virus will be challenged after participants screening and consent for hospitalization. After virus challenge, the virological, immunological and clinical manifestation will be recorded and analyzed for the result from day 0-60 post-virus challenge.
| Study group | Role | What they receive |
|---|---|---|
| Open label DENV2delta30 virus challenge | Experimental | Not described Receives: Biological: rDEN2Δ30-7169 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of rDEN2Δ30-7169 in Dengue immune participants
To evaluate the safety of rDEN2Δ30-7169 in dengue-immune participants as assessed by the frequency of virus-related adverse events (AEs), graded by severity.
Measured: Day 0 -60 after virus challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study startSep 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Challenge the attenuated virus in 12 dengue-immune participants
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Johns Hopkins University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908018
- Sponsor's protocol ID
- MU-MOU780/2567(IRB1)
- Acronym
- DHIT-Immune
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Virological and Immunological Assessment of the Controlled Dengue Human Infection Model in Dengue-Immune Participants in Thailand (DHIT-Immune)
- ClinicalTrials.gov ID
- NCT06908018
- Acronym / sponsor ID
- DHIT-Immune / MU-MOU780/2567(IRB1)
- Conditions
- Safety Issues, Dengue, Viremia, Immune-related Adverse Event
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Johns Hopkins University
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 of five Thai dengue naïve participants from previous project (registered number NCT05476757) demonstrated 100% viremia status without severe adverse event after 60 days post-virus challenge. However, result from previous project may not fully represent the clinical manifestation and immunological responses of major population of endemic areas, where most people in endemic area have dengue immune status. Therefore, this controlled human infection model protocol proposes to challenge the attenuated virus in 12 dengue-immune participants recruited from Bangkok metropolitan area, Thailand. We aim to assess the safety, viremia, NS1 antigenemia profile, and immunogenicity of the challenge virus in the dengue immune participants. After finish safety assessment, all participants will be vaccinated with a full course of dengue vaccines to prevent recurrent dengue infection. Immunological responses after vaccination will be also evaluated the vaccine efficacy.
Our expected outcomes are all participants present viremia profiles after virus challenge without serious adverse events (SAE). The exploratory profiles include assesment of immune profiles and parameters comparison with the other dengue challenge study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Challenge the attenuated virus in 12 dengue-immune participants
| Arm | Type | Receives |
|---|---|---|
| Open label DENV2delta30 virus challenge | Experimental | Biological: rDEN2Δ30-7169 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
- Willingness to participate in the study as evidenced by signing the informed consent document.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rDEN2Δ30-7169rDEN2Δ30-7169 is a recombinat virus that could induce viremia and immunological responses with out serious adverse effect. The virus will be challenged after participants screening and consent for hospitalization. After virus challenge, the virological, immunological and clinical manifestation will be recorded and analyzed for the result from day 0-60 post-virus challenge. | Biological | Open label DENV2delta30 virus challenge |
Primary outcome
The safety of rDEN2Δ30-7169 in Dengue immune participants
Time frame: Day 0 -60 after virus challenge
To evaluate the safety of rDEN2Δ30-7169 in dengue-immune participants as assessed by the frequency of virus-related adverse events (AEs), graded by severity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing rDEN2Δ30-7169 in people with Safety Issues and Dengue, run by Mahidol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Panisadee Avirutnan, M.D., Ph.D. (+6624196667-70, panisadee.avi@mahidol.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of rDEN2Δ30-7169 in Dengue immune participants (time frame: Day 0 -60 after virus challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.