Status:
COMPLETED
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN2/4delta30[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 Fever
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 test the safety of and immune response to a...
Detailed Description
Dengue viruses cause dengue fever, as well as 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...
Eligibility Criteria
Inclusion
- Willing to be followed for the duration of the study
- Willing to use acceptable methods of contraception
- Good general health
Exclusion
- Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
- Hematologic disease
- Alcohol or drug abuse 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 infected
- Hepatitis B surface antigen positive
- Known immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive drugs within 30 days prior to study entry. Participants who have used 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
- Blood products within 6 months prior to study entry
- Participation in another investigational vaccine or drug trial within 60 days of starting this study, or while this trial is ongoing
- Previously received a licensed or experimental yellow fever or dengue vaccine
- Surgical removal of spleen
- History of dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus, Japanese encephalitis virus)
- Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
- Plan to travel to an area where dengue infection is common
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00094705
Start Date
January 1 2005
End Date
April 1 2006
Last Update
January 21 2008
Active Locations (1)
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1
Johns Hopkins School of Public Health
Baltimore, Maryland, United States, 21205