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

NCT05691530 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2026-04-28

Study results available
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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, 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.

Conditions

  • Response To Dengue Exposure

Interventions

DRUG

rDEN3Δ30/31-7164

The rDEN3Δ30/31-7164 vaccine is a live attenuated virus constructed by creating two deletions in the 3' untranslated region (UTR) of the DENV-3 Sleman/78 strain. The vaccine dose consists of 0.5 mL of 10\^3.3 PFU/mL of rDEN3Δ30/31-7164 plus Plasma-Lyte A pH 7.4 diluent delivered subcutaneously into the deltoid area on day 0.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2025-04-23
Completion
2026-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05691530 on ClinicalTrials.gov