NCT00290147

Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine

An Open-Label, Dose Escalation, Phase I Safety, and Immunogenicity Trial of a Dengue Serotype 1 (DEN-1) Premembrane (prM) and Envelope (E) DNA Vaccine (D1ME100) in Healthy Adults Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	D1ME100 (dengue-1 premembrane/envelope DNA vaccine)	IM injection delivered by Biojector

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-12-01
• Completion: 2009-04-01
• First posted: 2006-02-10
• Last updated: 2017-06-20
• Results posted: 2017-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study