Status:
COMPLETED
Safety and Immune Response to Two Doses of rDEN2/4delta30 Dengue Vaccine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Dengue Fever
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 rDEN2/4delta30(ME) vacc...
Eligibility Criteria
Inclusion
- Good general health as determined by means of the screening procedures.
- Available for the duration of the study (32 weeks for cohort 1 and 23 weeks for cohort 2)
- Willing to use effective methods of contraception
Exclusion
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator will affect the ability of the volunteer to understand and cooperate with the requirements of the study protocol
- Neutropenia as defined by an ANC ≤1500/mm3
- ALT level above the laboratory-defined upper limit of normal
- Serum creatinine level above the laboratory-defined upper limit of normal
- Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
- History of a severe allergic reaction or anaphylaxis
- Severe asthma (emergency room visit or hospitalization within the last 6 months)
- Positive HIV-1 serology by screening and confirmatory assays
- Positive for hepatitis C virus (HCV) by screening and confirmatory assays
- Positive hepatitis B surface antigen (HBsAg) by enzyme-linked immunosorbent assay (ELISA)
- Known immunodeficiency syndrome
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study
- Receipt of a live vaccine within the 4 weeks or a killed vaccine within the 2 weeks prior to entry into the study
- Has had spleen surgically removed
- Receipt of blood products within the 6 months prior to study entry
- History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g. yellow fever virus, St. Louis encephalitis, West Nile virus).
- Previous receipt of yellow fever or dengue vaccine (licensed or experimental)
- Persons who have received any investigational agent in the 30 days prior to study entry
- Persons who have definite plans to travel to a dengue endemic area during the study
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00920517
Start Date
January 1 2009
End Date
January 1 2010
Last Update
January 3 2013
Active Locations (1)
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1
Center for Immunization Research
Baltimore, Maryland, United States, 21205