Status:
COMPLETED
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3/4delta30[ME]) 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, caused by dengue viruses, is a major health problem in the tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new ...
Detailed Description
Dengue viruses, which cause dengue fever and dengue shock syndrome, are a major cause of morbidity and mortality in several of the world's tropical and subtropical regions. The rDEN3/4delta30(ME) vacc...
Eligibility Criteria
Inclusion
- Good general health
- Available for the duration of the study
- Willing to use acceptable forms of contraception for the duration of the study
Exclusion
- 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
- Emergency room visit or hospitalization for severe asthma within 6 months prior to study entry
- HIV-1 infected
- Hepatitis C virus (HCV) infected
- Hepatitis B surface antigen positive
- Immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive medications within 30 days prior to study entry. Participants 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
- Previously received yellow fever or dengue vaccine
- 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 interfere with the study
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00375726
Start Date
October 1 2006
End Date
September 1 2008
Last Update
December 14 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Immunization Research
Baltimore, Maryland, United States, 21205