Status:
COMPLETED
Evaluation of the Safety and the Ability of a DNA Vaccine to Protect Against Dengue Disease
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
Vical
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Dengue Disease
Dengue Fever
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether a new investigational dengue vaccine is safe, well-tolerated, and to see if an immune response against dengue disease will be generated.
Detailed Description
Arguably the need for a tetravalent dengue vaccine that will effectively induce immunity against all four dengue serotypes has never been greater. Currently, several different approaches are being tak...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female age 18 to 50 (inclusive) years old at the time of enrollment
- Have negative anti-dengue, Japanese encephalitis, West Nile, and yellow fever ELISA serological tests
- Be informed of the nature of the study and provide written informed consent
- If the subject is of child-producing potential, he/she agrees to practice adequate birth control or abstain from sex
- Have access to the WRAIR Clinical Trials for at least 270 days, and be willing to refrain from participation in other investigational clinical trials
- Be in good general health
- Exclusion Criteria-Subjects meeting any of the following criteria will be excluded from the study:
- History of Flavivirus infection or history of Flavivirus vaccine (experimental or licensed product) including Japanese encephalitis, yellow fever, and dengue
- Have a known or suspected hypersensitivity or adverse reaction to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain
- Have received a live-attenuated vaccine within 42 days prior to the initial injection on Day 0 or a subunit or killed vaccine within 30 days of the initial injection on Day 0
- Have a positive screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or HIV antibody
- Are pregnant or breastfeeding
- Have donated or received blood, blood products, or plasma within 30 days prior to Day 0
- Have any acute illness, including an oral body temperature \>100.4°F, within 7 days before the initial injection on Day 0
- Have a past or current history of malignant disease except for adequately treated skin cancer
- Exclusions include but are not limited to conditions pertaining to or evidence of immunodeficiency; allergies requiring treatment with antigen injections; autoimmune disease; severe migraine headaches; unstable asthma; clinically significant cardiac arrhythmias, diabetes mellitus, thyroid disease, a bleeding disorder or a seizure disorder.
- Have participated in an investigational drug, vaccine, or device study within a period of 30 days prior to Day 0;
- History of splenectomy
- Planned travel to dengue endemic areas during the study period
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01502358
Start Date
December 1 2011
End Date
December 1 2013
Last Update
November 4 2016
Active Locations (1)
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1
Walter Reed Army Institute of Research and Clinical Trial Center (WRAIR CTC)
Silver Spring, Maryland, United States, 20702