Status:
COMPLETED
Safety of and Immune Response to Two Different Dengue Virus Vaccines in Individuals Previously Immunized Against Dengue Virus
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Johns Hopkins Bloomberg School of Public Health
Conditions:
Dengue Hemorrhagic 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 subtropical regions of the world. There are four different forms (serotypes) of dengue virus that can cause dengue fever. ...
Detailed Description
The World Health Organization estimates that dengue virus causes more than 50 million cases of dengue fever a year. Dengue virus infection is the leading cause of hospitalization and death in children...
Eligibility Criteria
Inclusion
- Previous vaccination with rDEN1delta30, rDEN2/4delta30(ME), OR rDEN4delta30 vaccine
- General good health
- Available for the duration of the study
- Willing to use accepted forms of contraception
Exclusion
- Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease by history, physical examination, or laboratory studies including urinalysis
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
- Certain abnormal laboratory values
- Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months of study entry
- History of severe allergy or anaphylaxis
- Severe asthma requiring an emergency room visit or hospitalization within 6 months of study entry
- HIV infected
- Hepatitis C virus infected
- Hepatitis B surface antibody positive
- Known immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive drugs 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.
- Receipt of live vaccine within 4 weeks of study entry
- Receipt of killed vaccine within 2 weeks of study entry
- Absence of spleen
- Plan to travel to an area where dengue virus is common
- Any investigational product within 30 days of study entry
- Other condition that, in the opinion of the investigator, would interfere with the study
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00458120
Start Date
March 1 2007
End Date
August 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