Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-4995) in Healthy Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: Dengue

In brief

Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to evaluate the safety and immune response to the dengue vaccine DEN4delta30-4995 in healthy adults.

Key facts

Study ID

NCT00322946

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

84

Starts

2007-01-01

Last updated by the study team

2009-08-07

Who can join

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

You may qualify if…

• Adult males and non-pregnant females between 18 and 50 years of age
• Good general health
• Available for the duration of the study
• Willing to use acceptable methods of contraception for the duration of the study

You may not qualify if…

• Significant neurologic, cardiac, 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
• Severe asthma
• HIV-1 serotype infected
• Hepatitis C virus (HCV) infected
• Hepatitis B surface antigen positive
• Immunodeficiency syndrome
• Use of corticosteroids or immunosuppressive medications within 2 weeks prior to study entry. Individuals 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
• Prior receipt of yellow fever or dengue vaccine (licensed or experimental)
• 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 affect participation in the study
• Pregnant or breastfeeding

Where it is running

• Vanderbilt University School of Medicine — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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