Evaluation of the Safety and the Ability of a DNA Vaccine to Protect Against Dengue Disease

Completed · Phase 1

Conditions studied: Dengue Disease, Dengue Fever

In brief

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.

Key facts

Study ID

NCT01502358

Run by

U.S. Army Medical Research and Development Command

People needed

40

Starts

2011-12-01

Expected to finish

2013-12-01

Last updated by the study team

2016-11-04

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

Where it is running

• Walter Reed Army Institute of Research and Clinical Trial Center (WRAIR CTC) — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.