MedTrace Logo

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

NCT02283099 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-05-30

No results posted yet for this study

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.

Conditions

  • Hemorrhagic Fever, Ebola

Interventions

BIOLOGICAL

rVSVΔ-ZEBOV-GP

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

Sponsors & Collaborators

  • German Center for Infection Research

    collaborator OTHER

  • Philipps University Marburg

    collaborator OTHER

  • World Health Organization

    collaborator OTHER

  • Clinical Trial Center North

    collaborator UNKNOWN

  • University Hospital, Geneva

    collaborator OTHER

  • Albert Schweitzer Hospital

    collaborator OTHER

  • Institute of Tropical Medicine, University of Tuebingen

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • KEMRI-Wellcome Trust Collaborative Research Program

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Marylyn M. Addo, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02283099 on ClinicalTrials.gov