NCT03110952

TDENV PIV and LAV Dengue Prime-boost Strategy Using AS03B Adjuvant

A Phase 1, Randomized, Placebo-Controlled, Observer-Blind, Single-Center, Study of TDENV-PIV and TDENV-F17 Dengue Vaccine Platforms in a Heterologous Prime Boost Strategy in Healthy Adults in a Non-Endemic Region

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 39 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 the GSK AS03B adjuvant 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. This study is being done to evaluate the safety and immune reaction of administering one dose of dengue purified inactivated vaccine and one dose of dengue live attenuated vaccine compared to two doses of inactivated vaccine.

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	TDENV-PIV	Single-dose vial with pre-filled syringe, subcutaneous injection
BIOLOGICAL	TDENV-F17	Single-dose vial with pre-filled syringe 0.5 mL administered intramuscularly
OTHER	Placebo	0.5 mL vial

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-04-01
• Completion: 2018-04-01
• First posted: 2017-04-12
• Last updated: 2017-04-12

Locations

1 site across 1 country: United States