Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: Dengue Fever

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 test the safety of and immune response to a new dengue virus vaccine in healthy adults.

Key facts

Study ID

NCT00089908

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

28

Starts

2004-09-01

Expected to finish

2005-11-01

Last updated by the study team

2008-01-18

Who can join

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

You may qualify if…

• Willing to be followed for the duration of the study
• Willing to use acceptable methods of contraception
• Good general health

You may not qualify if…

• Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
• Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
• Liver, renal, or hematologic disease
• Alcohol or drug abuse within 12 months of study entry
• History of severe allergic reaction or anaphylaxis
• Emergency room visit or hospitalization for severe asthma within 6 months of study entry
• HIV-1 infected
• HCV infected
• Hepatitis B surface antigen positive
• Known immunodeficiency syndrome
• Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical or nasal corticosteroids are not excluded.
• Live vaccine within 4 weeks of study entry
• Killed vaccine within 2 weeks of study entry
• Blood products within 6 months of study entry
• Investigational drugs or vaccines within 60 days prior to study entry or while currently enrolled in this clinical trial
• Previously received a licensed or experimental yellow fever or dengue vaccine
• Surgical removal of spleen
• History of dengue virus infection or other flavivirus infection
• Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
• Pregnancy or breastfeeding
• Plan to travel to an area where dengue infection is common

Where it is running

• Center for Immunization Research, Johns Hopkins School of Public Health — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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