drugset / Trial / NCT00290147
Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine
Phase 1
Completed
22 enrolled
U.S. Army Medical Research and Development Command
United States Army Medical Materiel Development Activity · collab
Non-randomizedSingle-groupOpen-labelPrevention
Summary
The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
Timeline
- Start
- 2006-01
- Primary completion
- 2006-12
- Completion
- 2009-04
Publications
- Danko JR, Kochel T, Teneza-Mora N, Luke TC, Raviprakash K, Sun P, Simmons M, Moon JE, De La Barrera R, Martinez LJ, Thomas SJ, Kenney RT, Smith L, Porter KR. Safety and Immunogenicity of a Tetravalent Dengue DNA Vaccine Administered with a Cationic Lipid-Based Adjuvant in a Phase 1 Clinical Trial. Am J Trop Med Hyg. 2018 Mar;98(3):849-856. doi: 10.4269/ajtmh.17-0416. Epub 2018 Jan 18.
- Beckett CG, Tjaden J, Burgess T, Danko JR, Tamminga C, Simmons M, Wu SJ, Sun P, Kochel T, Raviprakash K, Hayes CG, Porter KR. Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial. Vaccine. 2011 Jan 29;29(5):960-8. doi: 10.1016/j.vaccine.2010.11.050. Epub 2010 Nov 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | D1ME100 | Unknown | 1 mg | Intramuscular |
| Subject | D1ME100 | Unknown | 5 mg | Intramuscular |