Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3/4delta30[ME]) in Healthy Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: Dengue

In brief

Dengue fever, caused by dengue viruses, is a major health problem in the tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.

Key facts

Study ID

NCT00375726

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

58

Starts

2006-10-01

Expected to finish

2008-09-01

Last updated by the study team

2010-12-14

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Good general health
• Available for the duration of the study
• Willing to use acceptable forms of contraception for the duration of the study

You may not qualify if…

• Significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
• Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
• Significant laboratory abnormalities
• Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months prior to study entry
• History of severe allergic reaction or anaphylaxis
• Emergency room visit or hospitalization for severe asthma within 6 months prior to study entry
• HIV-1 infected
• Hepatitis C virus (HCV) infected
• Hepatitis B surface antigen positive
• Immunodeficiency syndrome
• Use of corticosteroids or immunosuppressive medications within 30 days prior to study entry. Participants using topical or nasal corticosteroids are not excluded.
• Live vaccine within 4 weeks prior to study entry
• Killed vaccine within 2 weeks prior to study entry
• Absence of spleen
• Blood products within 6 months prior to study entry
• Previous dengue virus or other flavivirus (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus) infection
• Previously received yellow fever or dengue vaccine
• Plans to travel to an area where dengue infection is common
• Received an investigational agent within 30 days prior to study entry
• Other condition that, in the opinion of the investigator, would interfere with the study
• Pregnancy or breastfeeding

Where it is running

• Center for Immunization Research — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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