Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary… (NCT07706686) | Clinical Trial Compass
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
United States200 participantsStarted 2026-08-07
Plain-language summary
Background:
Dengue is a viral disease spread by mosquitoes. Most people bitten by mosquitoes carrying dengue viruses do not get sick, but severe cases can cause shock, internal bleeding, and death. There are no treatments for dengue. To develop treatments, researchers need to understand more about what dengue viruses do in the body.
Objective:
To infect healthy people with a mild dengue virus to study how their body responds.
Eligibility:
People ages 18 to 50 years with or without a history of dengue virus infection.
Design:
Participants will be screened. They will have a physical exam with blood tests. The tests will show whether they have ever been infected with dengue or related viruses in the past.
At their first study visit, participants will receive an injection of dengue virus into the arm. The injected virus is weaker than the natural virus, so any symptoms should be milder.
Participants will have a total of 11 study visits over 6 months; 8 of those visits will be in the first month. Blood will be drawn at each visit. Some visits will include ultrasound exams of their internal organs. They will discuss any symptoms they are having. Any rashes they develop may be photographed.
Two procedures are optional: Participants may have up to 5 lymph node aspirations and 3 bone marrow biopsies during the study. For both procedures, a needle will be inserted into the tissues to draw out immune cells.
Two more visits are optional: 1 visit up to 2 months before receiving the virus, for lymph node or bone marrow samples, and 1 about a year after for a blood draw.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18 to 50 years.
. In good general health as evidenced by medical history, physical examination, and laboratory screening results
. Willing to allow storage of samples and data for future research.
. Willing to forgo receipt of any vaccine in the 28 days preceding the challenge strain through the 28 days following administration of the challenge strain. For participants opting for LN FNA or bone marrow sampling on day 57, they must be willing to forgo any vaccine through day 57. For those opting for FNA or bone marrow sampling on day 180, they must be willing to forgo any vaccine for at least 28 days before sampling.
. For individuals who can become pregnant: use of at least one method of effective contraception (see below) from at least 28 days prior to challenge through 60 days after challenge.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The frequency and severity of AEs through day 28 and SAEs through day 180.
Timeframe: Through Day 180
2
Fold difference between groups in peak viral RNAemia titers on any day from days 2 to 19.
Timeframe: Through Day 19
3
Fold change in DENV1-4 neutralizing antibody GMTs between days 0 and 28 within each group.
Timeframe: Through Day 28
Trial details
NCT IDNCT07706686
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Willing to adhere to lifestyle considerations for the duration of the study.
. Willing to avoid travel to a dengue-endemic area as defined by the CDC from 1 month before administration of challenge through day 28. For participants opting for LN FNA or bone marrow sampling on day 57, they must be willing to forgo travel through day 57.
Exclusion criteria
. Pregnancy.
. Lactation during the first 28 days of the study.