Safety Study of a Dengue Virus DNA Vaccine
The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
Biological: D1ME (dengue-1 premembrane/envelope DNA vaccine)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase I Clinical Trial of a Dengue-1 DNA Vaccine|
- Safety and reactogenicity as evaluated by clinical visits and safety labs.
- Measurement of anti-dengue antibody and T cell responses.
|Study Start Date:||January 2006|
|Study Completion Date:||April 2009|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
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.
|United States, Maryland|
|Walter Reed Army Institute of Research, Bldg 503|
|Silver Spring, Maryland, United States, 20910|
|Principal Investigator:||Charmagne Beckett, MD||Naval Medical Research Center|