Trials / Completed
CompletedNCT02372175
Assessment of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain
Phase One, Open Label, Assessment of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- U.S. Army Medical Research and Development Command · Federal
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to develop an appropriate challenge model. To this end, this first-in-human study will examine the safety and effectiveness of the Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) product and assess the ability of this virus strain to elicit an uncomplicated dengue-like illness.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC) | Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5 administered as a single injection. |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2019-06-28
- Completion
- 2019-06-28
- First posted
- 2015-02-26
- Last updated
- 2019-07-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02372175. Inclusion in this directory is not an endorsement.