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NCT05691530 · ClinicalTrials.gov registry record · Phase 1
Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine
A Phase 1 study of Response To Dengue Exposure, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 127
- Enrollment target
- 1
- Study location
NCT05691530: Active Phase 1 study of Response To Dengue Exposure, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05691530 is a Phase 1 study of Response To Dengue Exposure that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 127 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05691530, a Phase 1 study of Response To Dengue Exposure, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 127 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Dengue is a disease caused by a virus transmitted by mosquitoes in tropical and subtropical regions. Dengue is a leading cause of hospital stays and death in parts of Asia and Latin America, and outbreaks have occurred in the US. Currently, only one vaccine is licensed for dengue, but it only protects people who have had dengue before. In people who have never had dengue, that vaccine increases the risk of severe disease. Better vaccines are needed. Objectives: To test a potential new vaccine against dengue. To see if side effects and immune responses are different depending on a person s previous exposure to dengue. Eligibility: Healthy people aged 18 to 59 years. Design: Participants will visit the clinic 11 times in 7 months; 9 of those visits will be in the first 2 months. Two additional visits are optional. Participants will be screened. They will have a physical exam with urine and blood tests. They will complete a survey about their travel history. Participants may opt to have a lymph node aspiration before receiving the study vaccine. An area in the left armpit will be numbed. A needle will be inserted to remove some cells from a lymph node. The vaccine will be injected into the fat under the skin of the participant s upper left arm. Participants will return for a provider visit and blood draws every 3 days for about the first 2 weeks. Then they will return for a provider visit and blood draws after longer intervals up to 7 months. The lymph node aspiration may be repeated at later visits. Participants may opt to return for a last visit after 12 months.
Primary Outcome
Number of participants with at least one solicited local adverse events occurring within twenty-eight days of vaccine administration. Local reactogenicity included injection site pain, injection site tenderness, injection site bruising, injection site redness, injection site erythema, injection site swelling/induration, and injection site pruritus. Adverse events were captured by investigator examination and history from participants.
Conditions Studied
Interventions
- DRUG rDENdelta30/31-7164
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2023-03-07 |
| Est. Completion | 2026-05-01 |
| Phase | Phase 1 |
What the registry record for NCT05691530 still lists
NCT05691530 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher).
The record links to 1 condition, with Response To Dengue Exposure appearing as the primary indexed condition, and to 1 intervention - of which rDENdelta30/31-7164 is the first listed.
NCT05691530 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05691530 about?
NCT05691530 is a clinical study titled "Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine". Background: Dengue is a disease caused by a virus transmitted by mosquitoes in tropical and subtropical regions. Dengue is a leading cause of hospital stays and death in parts of Asia and Latin America, and outbreaks have occurred in the US. Currently, only one vaccine is licensed for dengue, but i...
What is the current status of trial NCT05691530?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2023-03-07. Estimated completion is 2026-05-01.
What conditions does trial NCT05691530 study?
This clinical trial studies the following conditions: Response To Dengue Exposure.
What interventions are being tested in trial NCT05691530?
The interventions under investigation include: rDENdelta30/31-7164 (DRUG).
Who is sponsoring clinical trial NCT05691530?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05691530 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05691530's enrollment target sits among peer trials
127 459th of 2000 higher than 1,540 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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