Hemorrhagic Fever, Ebola Clinical Trial
Official title:
An Open Label, Single Center, Dose Escalation Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Single Ascending Dose of the Ebola Virus Vaccine rVSVΔG-ZEBOV-GP (BPSC1001)
The study is designed to establish safety, tolerability and immunogenicity of rVSVΔG-ZEBOV-GP (BPSC1001), an Ebola Virus Vaccine candidate (recombinant vesicular stomatitis virus (VSV) expressing the envelope glycoprotein of Ebola Virus Zaire), investigated at three different dose levels in 30 healthy adults in Germany. This study is part of the WHO led VEBCON consortium that is aiming to generate harmonized data for the rVSVΔG-ZEBOV-GP (BPSC1001) vaccine candidate to allow optimized rapid decisions on dose and safety.
This study is being conducted to assess safety and immunogenicity of an experimental ebola
vaccine.
An outbreak due to the Ebola Zaire (ZEBOV) strain of unprecedented magnitude and scope and
with a high mortality continues to spread across West Africa. No vaccine is currently
licensed.
The specific opportunity at hand with rVSVΔG-ZEBOV-GP (BPSC1001) is to achieve long-lasting
protective immunity to ZEBOV on a time scale of weeks in humans upon a single-shot
vaccination, offering a discrete benefit over prime-boost vaccination protocols. The current
outbreak represents a global health emergency and the need for access to therapeutic
intervention and vaccines is paramount.
The vaccine investigated in this study might provide a critical tool to suppress future
out-breaks of EVD in areas at risk.
This study is 1 of 4 clinical trials currently conducted as part of the WHO-led VEBCON
consortium, aiming to generate harmonized data for the rVSVΔG-ZEBOV-GP (BPSC1001) vaccine
candidate to allow optimized rapid decisions on dose and safety.
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