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

Completed · Phase 1

Conditions studied: Response To Dengue Exposure

In brief

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.

Key facts

Study ID

NCT05691530

Run by

National Institutes of Health Clinical Center (CC)

People needed

127

Starts

2023-03-07

Expected to finish

2025-10-27

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Pregnant at screening.
• History of or positive test result for HIV, hepatitis B, or hepatitis C.
• History of previous dengue vaccine.
• Has any of the following:
• More than 10 days of systemic immunosuppressive medications (>=10 mg prednisone dose or its equivalent) or cytotoxic medication within the 30 days prior to vaccination or immunomodulating therapy within 180 days prior to vaccination.
• Received blood products, including immunoglobulin products, within 120 days prior to vaccination.
• History of serious reactions to vaccines.
• Hereditary, acquired, or idiopathic forms of angioedema.
• Idiopathic urticaria within the past year.
• Asthma that is not well controlled or required emergency care, urgent care, hospitalization, or intubation during the past two years or that requires the use of oral or intravenous steroids.
• Type 1 or type 2 diabetes mellitus that is not well controlled (hemoglobin A1c > 8).
• Clinically significant autoimmune disease or immunodeficiency.
• Blood pressure >= 180/110 (stage 3 hypertension) on at least 2 measures.
• Documented diagnosis of a bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
• Significant bruising or bleeding difficulties with subcutaneous injections or blood draws.
• Malignancy that is active or treated malignancy for which there is no reasonable assurance of sustained cure, or malignancy that is likely to recur during the study period.
• Asplenia or functional asplenia.
• Current alcohol or drug abuse or addiction and/or positive drug screen with substances other than marijuana.
• Any medical, psychiatric, or social condition that, in the judgement of the investigator, is a contraindication to protocol participation.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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