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Phase 1 Study of rDEN2delta30-7169 for Dengue Virus Infection

This study is looking for healthy volunteers, aged 18 to 50, to understand how the body responds to dengue virus infection. Researchers will use a weakened form of the dengue virus, called rDEN2delta30-7169, to infect participants. This will help them learn more about how dengue viruses work in the body, especially in people who have or have not had dengue before. The main goals are to check the safety of rDEN2delta30-7169 and to see how the body's immune system reacts. They will measure side effects for up to 180 days and look at how much virus is in the blood and changes in protective antibodies for up to 28 days. The study is currently unclear on its recruitment status and plans to enroll 200 participants.

Study design
This is a Phase 1 interventional human challenge trial. It will involve healthy adults who have never had dengue, or who have had specific types of dengue infections in the past.
What's involved
Participants will undergo a screening process, including a physical exam and blood tests. They will be infected with the rDEN2delta30-7169 virus.
Compensation
Not stated in the trial record.
Follow-up
The study will monitor for side effects for up to 180 days. Viral levels and antibody changes will be measured for up to 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07706686

Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection

Recruiting
PHASE1Ages 18–50InterventionalBasic science
National Institute of Allergy and Infectious Diseases (NIAID)
~200 participants
Updated 2026-09-10 on ClinicalTrials.gov
What's tested:rDEN2delta30-7169

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The frequency and severity of AEs through day 28 and SAEs through day 180.
Measured over Through Day 180
+2 more outcomes measured

Conditions

Healthy Volunteers
Dengue
Human Challenge Trial

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NCT07706686

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Camila D Odio, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

Who to contact

Camila D Odio, M.D.
[email protected]
(240) 338-4945
Email the study team

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Eligibility criteria

Inclusion

Intrauterine device or equivalent.
Hormonal contraceptive (e.g., consistent, timely, and continuous use of contraceptive pill, patch, ring, implant, or injection that has reached full efficacy prior to challenge).
Condom, diaphragm, or cervical cap plus spermicide.
A stable, long-term monogamous relationship with a partner who does not pose any potential pregnancy risk, e.g., has undergone a vasectomy at least 6 months prior to administration of challenge strain or is of the same sex as the participant.
A hysterectomy and/or a bilateral tubal ligation, bilateral oophorectomy, or post-menopausal status defined as age \>=45 years and at least 1 year since last menstrual period.

What this trial measures

  • The frequency and severity of AEs through day 28 and SAEs through day 180.Through Day 180

    Evaluate the safety of the challenge strain in all groups.

  • Fold difference between groups in peak viral RNAemia titers on any day from days 2 to 19.Through Day 19

    Evaluate viral replication by qRT-PCR and compare the peak replication among groups.

  • Fold change in DENV1-4 neutralizing antibody GMTs between days 0 and 28 within each group.Through Day 28

    Evaluate the immunogenicity of the challenge by examining the change in antibody titers in each group.