Status:
COMPLETED
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3-3'Ddelta30) in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Dengue
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
Dengue viruses cause dengue fever and the more severe dengue hemorrhagic fever/shock syndrome. More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue ...
Eligibility Criteria
Inclusion
- General good health
- Available for the duration of the study
- Willing to use accepted forms of contraception
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00712803
Start Date
December 1 2008
End Date
September 1 2009
Last Update
January 3 2013
Active Locations (2)
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1
Center for Immunization Research, Johns Hopkins School of Public Health
Washington D.C., District of Columbia, United States, 20037
2
Center for Immunization Research, Johns Hopkins University of Public Health
Baltimore, Maryland, United States, 21205