Clinical Trial: Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine (rVSVΔG-ZEBOV-GP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 rVS

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Universitätsklinikum Hamburg-Eppendorf

Current Primary Outcome: The number of adverse events associated with the rVSVΔ-ZEBOV-GP (BPSC1001) vaccine will be collected and measured [ Time Frame: Vaccination (day 0) to day 180 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ZEBOV-GP-specific antibody responses [ Time Frame: Vaccination (day 0) to day 180 ]
    Humoral immunity: Magnitude of ZEBOV-GP-specific antibody responses as assayed by ELISA in a centralized laboratory.
  • To evaluate vaccine viremia and excretion [ Time Frame: Vaccination (day 0) to day 28 ]
    Vaccine viremia and viral shedding: concentration of rVSV in peripheral blood, urine and saliva as detected by qRT-PCR


Original Secondary Outcome: Same as current

Information By: Universitätsklinikum Hamburg-Eppendorf

Dates:
Date Received: October 31, 2014
Date Started: November 2014
Date Completion:
Last Updated: August 18, 2016
Last Verified: August 2016