Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine

Completed · Phase 1

Conditions studied: Dengue

In brief

The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.

Key facts

Study ID

NCT00290147

Run by

U.S. Army Medical Research and Development Command

People needed

22

Starts

2006-01-01

Expected to finish

2009-04-01

Last updated by the study team

2017-06-20

Who can join

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

You may qualify if…

• Available to participate for the duration of the study (approximately 12 months)
• Completion and review of knowledge assement quiz

You may not qualify if…

• Pregnant (by history or as ascertained by pregnancy test) or lactating female
• Female who intends to become pregnant during the study
• Plan to have elective surgery during the study period
• HIV infection
• Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and topical steroids are allowed)
• History of splenectomy
• Administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 30 days after vaccination
• Evidence of active (acute or chronic) hepatitis B or C infection
• Autoimmune diseaseor subjects who describe a first-degree relative with clearly documented autoimmune disease
• Acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal abnormality, as determined by physical examination or basic laboratory screening
• Clinical or laboratory evidence of significant anemia
• History of flavivirus infection or previous receipt of flavivirus vaccine
• Positive serology for flaviviruses (all four dengue virus serotypes, Japanese encephalitis, Yellow fever virus, and West Nile virus), HIV-1, Hepatitis B surface antigen, or anti-hepatitis C virus antibodies prior to enrollment
• Use of any investigational or non-registered drug or vaccine other than the study vaccine within 60 days preceding the first dose of study vaccine, or planned use during the study period.
• Previous history of allergic or anaphylactic reaction to any vaccine
• Planned travel to areas with endemic dengue during the study period
• Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol

Where it is running

• Walter Reed Army Institute of Research, Bldg 503 — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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