Safety of and Immune Response to Two Different Dengue Virus Vaccines in Individuals Previously Immunized Against Dengue Virus

Completed · Phase 1 · Has a placebo group

Conditions studied: Dengue Hemorrhagic Fever

In brief

Dengue fever, which is caused by dengue viruses, is a major health problem in subtropical regions of the world. There are four different forms (serotypes) of dengue virus that can cause dengue fever. The purpose of this study is to determine the safety and immune response to a vaccine containing a particular dengue serotype when an individual has been previously vaccinated with a different dengue serotype.

Key facts

Study ID

NCT00458120

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

36

Starts

2007-03-01

Expected to finish

2008-08-01

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…

• Previous vaccination with rDEN1delta30, rDEN2/4delta30(ME), OR rDEN4delta30 vaccine
• 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
• 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 — 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.