NCT02283099

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Hemorrhagic Fever, Ebola

Interventions

Type	Name	Description
BIOLOGICAL	rVSVΔ-ZEBOV-GP	single dose of rVSVΔ-ZEBOV-GP (3x10\^6 pfu, 2x10\^7 pfu or 3x10\^5)

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-11-05
• Last updated: 2017-05-30

Locations

1 site across 1 country: Germany