drugset / Trial / NCT00831012
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3delta30/31-7164) in Healthy Adults
Phase 1
Completed
56 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Johns Hopkins Bloomberg School of Public Health · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.
Timeline
- Start
- 2009-09
- Primary completion
- 2011-06
- Completion
- —
Publications
- Popper SJ, Strouts FR, Lindow JC, Cheng HK, Montoya M, Balmaseda A, Durbin AP, Whitehead SS, Harris E, Kirkpatrick BD, Relman DA. Early Transcriptional Responses After Dengue Vaccination Mirror the Response to Natural Infection and Predict Neutralizing Antibody Titers. J Infect Dis. 2018 Nov 5;218(12):1911-1921. doi: 10.1093/infdis/jiy434.
- Katzelnick LC, Fonville JM, Gromowski GD, Bustos Arriaga J, Green A, James SL, Lau L, Montoya M, Wang C, VanBlargan LA, Russell CA, Thu HM, Pierson TC, Buchy P, Aaskov JG, Munoz-Jordan JL, Vasilakis N, Gibbons RV, Tesh RB, Osterhaus AD, Fouchier RA, Durbin A, Simmons CP, Holmes EC, Harris E, Whitehead SS, Smith DJ. Dengue viruses cluster antigenically but not as discrete serotypes. Science. 2015 Sep 18;349(6254):1338-43. doi: 10.1126/science.aac5017.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rDEN3delta30/31-7164 | Vaccine | 10 unknown | Subcutaneous |
| Subject | rDEN3delta30/31-7164 | Vaccine | 1000 unknown | Subcutaneous |
| Subject | rDEN3delta30/31-7164 | Vaccine | 100000 unknown | Subcutaneous |