Dengue Fever Clinical Trial
— TVDVOfficial title:
A Phase 1 Study To Evaluate The Safety, Tolerability, and Immunogenicity of a Tetravalent Dengue (Serotype 1, 2, 3, and 4) Plasmid DNA Vaccine (TVDV) Formulated With and Without Vaxfectin®
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed Army Institute of Research and Clinical Trial Center (WRAIR CTC) | Silver Spring | Maryland |
Lead Sponsor | Collaborator |
---|---|
U.S. Army Medical Research and Materiel Command | Naval Medical Research Center, Vical, Walter Reed Army Institute of Research (WRAIR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events (AEs) or serious adverse events (SAEs) | All AEs and SAEs will be recorded during the entire duration of the study, or up to 360 days. | Up to Day 360 | Yes |
Secondary | Percent of subjects (in each group) achieving tetravalent ELISA IgM seroconversion | From date of first vaccine dose until seroconversion is achieved, up to 360 days. | Days 0-360 | No |
Secondary | Percent of subjects (in each group) achieving tetravalent seroconversion, by dengue plaque reduction MN50 titer | From date of first vaccine dose until seroconversion is achieved, up to 360 days. | Days 0-360 | No |
Secondary | MN50 titer 1 month (Study Day 120) and Study Days 180 and 270 after vaccine regimen is complete | Following completion of study days 120 and 180 and 270 days after vaccine regimen is complete | No |
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