drugset / Trial / NCT03583606

A Trial to Evaluate the Safety and Systems Biology Response of Ebolavirus Zaire Vaccine (ChAd3-EBO-Z)

NCT03583606

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This initial, proof of concept study will focus on identifying significant differences in response to the Ebolavirus Zaire vaccine (ChAd3-EBO-Z) when administered with placebo, MVA-BN(R)-Filo, or ChAd3-EBO-Z boosters after 8 days. All 60 participants will receive the ChAd3-EBO-Z vaccine and then randomized into each booster group (20 receiving each type of booster). Subjects will be followed-up for 6 months to monitor for safety outcomes and efficacy measures. There is no formal hypothesis for this study. The primary objective of this study is to assess the safety and reactogenicity of study products by study group when administered IM to healthy adults.

Timeline

Start
2018-11-12
Primary completion
2020-01-14
Completion
2020-01-14

Drugs

EvaluationDrugModalityDoseRoute
Subject ChAd3-EBO-Z Vaccine 2e+11 unknown Intramuscular
Subject MVA Multi-Filo Ebola Vaccine Vaccine 1e+08 iu Intramuscular