Safety of and Immune Response of a 2-dose Regimen of rDEN1delta30 Dengue Virus Vaccine

Completed · Phase 1 · Has a placebo group

Conditions studied: Dengue

In brief

Dengue fever, 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 of and immune response to a 2-dose regimen of a new monovalent dengue virus vaccine. This study will test the dengue virus vaccine DEN1delta30 in healthy adults.

Key facts

Study ID

NCT00473135

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Starts

2007-05-01

Last updated by the study team

2010-01-13

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 (23 weeks for Cohort 1 and 32 weeks for Cohort 2)
• Willing to use acceptable forms of contraception for the duration of the study

You may not qualify if…

• Clinically 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
• Severe asthma
• HIV-1 infected
• Hepatitis C virus (HCV) infected
• Hepatitis B surface antigen positive
• Known immunodeficiency syndrome
• Use of corticosteroids or immunosuppressive medications within 30 days prior to study entry. Individuals using topical or nasal corticosteroids are not excluded.
• Previous receipt of a live vaccine within 4 weeks prior to study entry
• Previous receipt of a killed vaccine within 2 weeks prior to study entry
• Absence of spleen
• Previous receipt of blood products within 6 months prior to study entry
• Previous receipt of dengue virus or other flavivirus (e.g., yellow fever virus, St.Louis encephalitis, West Nile virus) infection
• Previous receipt of yellow fever or dengue vaccine
• Plans to travel to an area where dengue infection is common
• Previous receipt of any 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

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

Full record on ClinicalTrials.gov

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