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ACTIVE NOT RECRUITING
NCT05691530
PHASE1

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

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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.

Official title: Phase 1 Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine

Key Details

Gender

All

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

127

Start Date

2023-03-07

Completion Date

2026-05-01

Last Updated

2025-10-06

Healthy Volunteers

No

Interventions

DRUG

rDENdelta30/31-7164

The rDEN3delta30/31-7164 vaccine is a live attenuated virus constructed by creating two deletions in the 3 UTR of the DENV3 Sleman/78 strain. The rDEN3delta30/31-7164 vaccine will be delivered subcutaneously into the left deltoid area on day 0. The vaccine dose will consist of 0.5 mL of 10\^3 PFU/mL of rDEN3delta30/31-7164 plus Plasma-Lyte A pH 7.4 diluent.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States