drugset / Trial / NCT03110952

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

NCT03110952 ↗

RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2016-01
Primary completion
2017-04
Completion
2018-04

Outcome

Outcome not reported

Stopped: “lack of materials, not moving forward”

Drugs

EvaluationDrugModalityDoseRoute
Subject TDENV-F17 Vaccine 0.5 ml Intramuscular
Subject TDENV-PIV Vaccine 1 ug Subcutaneous

Indications