The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
Dengue is a desease that affects 100 million people throughout the world mainly in tropical countries in the South Pacific, Asia, the Caribbean, and Africa. The disease often presents with high fever, severe headache, and joint/muscle pain that usually goes away on its own, but it can also present as a sometimes deadly hemorrhagic (bleeding) disease. Humans catch this disease by being bitten by mosquitoes that have been infected with dengue virus. Scientists at the Naval Medical Research Center have been working on vaccines to prevent dengue disease. This vaccine, referred to as D1ME, is an experimental DNA vaccine that contains genes from the dengue-1 virus. The purpose of this study is to test the safety of a new experimental vaccine against dengue and to see if the vaccine can stimulate the immune system.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
22
IM injection delivered by Biojector
Walter Reed Army Institute of Research, Bldg 503
Silver Spring, Maryland, United States
Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Summary of ungraded systemic and local reactogenicity symptoms following each vaccination
Time frame: Months 0, 1 and 5
Anti-dengue Antibody and T-cell and B-cell Responders
Number of participants who responded, are reported. Response or a positive ELISPOT assay was defined as \>65 spot forming cells per million PBMC for T-cells and \>20 spot forming cells per million PBMC for B-cells
Time frame: 12 months
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