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)

NCT02283099 Phase 1 COMPLETED

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.

Details

Lead sponsor	Universitätsklinikum Hamburg-Eppendorf
Phase	Phase 1
Status	COMPLETED
Enrolment	30
Start date	2014-11
Completion	2015-11

Conditions

• Hemorrhagic Fever, Ebola

Interventions

• rVSVΔ-ZEBOV-GP

Primary outcomes

• The number of adverse events associated with the rVSVΔ-ZEBOV-GP (BPSC1001) vaccine will be collected and measured — Vaccination (day 0) to day 180

Countries

Germany