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Clinical trialNCT05691530CompletedPhase 1Interventional

Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine

SponsorNational Institutes of Health Clinical Center (CC)Enrollment127Response To Dengue Exposure
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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, dengue vaccines are limited and do not protect all people equally. One vaccine actually increased the risk of severe disease in some people and was taken off the market. 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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Camila D Odio, M.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • National Institutes of Health Clinical Center

    Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

RDEN3Δ30/31-7164
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
7 Mar 2023
Primary completion
23 Apr 2025
Completion
27 Oct 2025
Last update posted
16 Jun 2026
Registered enrollment
127
Registry id
NCT05691530

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.