Status:
COMPLETED
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-4995) in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Johns Hopkins Bloomberg School of Public Health
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 and immune response to ...
Detailed Description
Dengue viruses account for more than 50 million cases of dengue fever and a half million cases of the more severe disease, dengue hemorrhagic fever/dengue shock syndrome. Infection with dengue viruses...
Eligibility Criteria
Inclusion
- Adult males and non-pregnant females between 18 and 50 years of age
- Good general health
- Available for the duration of the study
- Willing to use acceptable methods of contraception for the duration of the study
Exclusion
- Significant neurologic, cardiac, 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 serotype infected
- Hepatitis C virus (HCV) infected
- Hepatitis B surface antigen positive
- Immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive medications within 2 weeks prior to study entry. Individuals using topical or nasal corticosteroids are not excluded.
- Live vaccine within 4 weeks prior to study entry
- Killed vaccine within 2 weeks prior to study entry
- Absence of spleen
- Blood products within 6 months prior to study entry
- Previous dengue virus or other flavivirus (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus) infection
- Prior receipt of yellow fever or dengue vaccine (licensed or experimental)
- Plans to travel to an area where dengue infection is common
- Received an 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00322946
Start Date
January 1 2007
Last Update
August 7 2009
Active Locations (1)
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1
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232-2581