CORE Protocol - A phase 1/2/3 study to evaluate the safety, tolerability, immunogenicity, and efficacy of vaccine candidates against (Filoviruses) virus disease in healthy individuals at risk of (Filovirus) virus disease

Overview

This adaptive multi-stage, multi-arm Solidarity Against (Filoviruses) Vaccine study protocol is designed as a living protocol that will be used to study the safety, immunogenicity, and efficacy of filovirus-candidate vaccines in African (Filoviruses)-prone countries. It will be a phase 1-2 study during the inter-epidemic periods, and phase 1-3 study during outbreaks

This vaccine study is a multistage and multiple-arm clinical study designed to assess the safety, immunogenicity, and efficacy of candidate Filoviruses virus (FV) vaccines in Africa. Certain African countries are prone to Ebola virus disease (EBOV) outbreaks caused by the most prevalent species Ebola Zaire (EBOV), and Ebola Sudan (SUDV) and Marburg virus disease (MVD) outbreaks caused by Marburg virus (MARV).