Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3-3'Ddelta30) in Healthy Adults

Completed · Phase 1

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

Key facts

Study ID

NCT00712803

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

29

Starts

2008-12-01

Expected to finish

2009-09-01

Last updated by the study team

2013-01-03

Who can join

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

You may qualify if…

• General good health
• Available for the duration of the study
• Willing to use accepted forms of contraception

You may not qualify if…

• Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease by history, physical examination, or laboratory studies including urinalysis
• Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
• Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
• Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months of study entry
• History of severe allergy or anaphylaxis
• Severe asthma requiring an emergency room visit or hospitalization within 6 months of study entry
• HIV infected
• Hepatitis C virus infected
• Hepatitis B surface antibody positive
• Known immunodeficiency syndrome
• Use of corticosteroids or immunosuppressive drugs 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.
• Receipt of live vaccine within 4 weeks of study entry
• Receipt of killed vaccine within 2 weeks of study entry
• Absence of spleen
• Plan to travel to an area where dengue virus is common
• Any investigational product within 30 days of 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, Johns Hopkins School of Public Health — Washington D.C., District of Columbia, United States
• Center for Immunization Research, Johns Hopkins University of Public Health — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.