Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine
Dengue
About this trial
This is an interventional prevention trial for Dengue focused on measuring Dengue, DNA vaccine
Eligibility Criteria
Inclusion Criteria: Available to participate for the duration of the study (approximately 12 months) Completion and review of knowledge assement quiz Exclusion Criteria: 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
Sites / Locations
- Walter Reed Army Institute of Research, Bldg 503
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1.0 mg of D1ME100 vaccine
5.0 mg of D1ME100 vaccine
1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months