Trials / Completed
CompletedNCT02239614
TDENV PIV and LAV Dengue Prime-boost Strategy
A Phase 1, Randomized, Open-label, Single-center, Study of TDENV-PIV and LAV Dengue Vaccine Platforms as Part of a Heterologous Prime-boost Strategy in Healthy Adults in a Nonendemic Region
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- U.S. Army Medical Research and Development Command · Federal
- Sex
- All
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
The potential synergistic effect of administering 2 dengue vaccine candidates that were previously shown to be safe and immunogenic in humans will be evaluated in this study. A prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with alum and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine Formulation 17 (F17) will gather data to help better understand the human immune response to dengue vaccination and infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TDENV-LAV | 0.5 mL of the post-transfection LAV F17 vaccine |
| BIOLOGICAL | TDENV-PIV 4 µg + alum adjuvant | 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2016-02-17
- Completion
- 2017-02-17
- First posted
- 2014-09-15
- Last updated
- 2018-08-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02239614. Inclusion in this directory is not an endorsement.