Status:
COMPLETED
Safety of and Immune Response of a 2-dose Regimen of rDEN1delta30 Dengue Virus Vaccine
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 tropical and subtropical regions of the world. The purpose of this study is to evaluate the safety of and immune response to a 2-do...
Detailed Description
Dengue viruses account for more than 50 million cases of dengue fever and one half million cases annually of dengue hemorrhagic fever/shock syndrome. Dengue virus infections can cause illness ranging ...
Eligibility Criteria
Inclusion
- Good general health
- Available for the duration of the study (23 weeks for Cohort 1 and 32 weeks for Cohort 2)
- Willing to use acceptable forms of contraception for the duration of the study
Exclusion
- Clinically 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
- Severe asthma
- HIV-1 infected
- Hepatitis C virus (HCV) infected
- Hepatitis B surface antigen positive
- Known immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive medications within 30 days prior to study entry. Individuals using topical or nasal corticosteroids are not excluded.
- Previous receipt of a live vaccine within 4 weeks prior to study entry
- Previous receipt of a killed vaccine within 2 weeks prior to study entry
- Absence of spleen
- Previous receipt of blood products within 6 months prior to study entry
- Previous receipt of dengue virus or other flavivirus (e.g., yellow fever virus, St.Louis encephalitis, West Nile virus) infection
- Previous receipt of yellow fever or dengue vaccine
- Plans to travel to an area where dengue infection is common
- Previous receipt of any 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 :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00473135
Start Date
May 1 2007
Last Update
January 13 2010
Active Locations (1)
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1
Center for Immunization Research, Johns Hopkins School of Public Health
Baltimore, Maryland, United States, 21205