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

May 24, 2017 updated by: Universitätsklinikum Hamburg-Eppendorf

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • CTC North GmbH & Co. KG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to understand the subject information and to personally sign the informed consent
  • Provided written informed consent.
  • Healthy females and males aged 18 - 55 years .
  • No clinically significant health problems
  • Body mass index 18.5 - 30.0 kg/m2 and weight >50 kg at screening.
  • Females of childbearing potential who agree to comply with the applicable contraceptive requirements of the protocol or females who are permanently sterilized.
  • Males who agree to comply with the applicable contraceptive requirements of the protocol
  • Subjects must be willing to minimize blood and body fluid exposure of others for 7 days after vaccination
  • Be willing to refrain from blood donation during the course of the study.
  • The subject is co-operative and available for the entire study.

Exclusion Criteria:

  • Prior receipt of an Ebolavirus or Marburgvirus vaccine or VSV-vectored vaccine.
  • Receipt of any vaccine in the 2 weeks prior to the trial vaccination (4 weeks for live vaccines) or planned receipt of any vaccine in the 3 weeks following the trial vaccination.
  • Known allergy to the components of the BPSC1001 vaccine product or history of life-threatening reactions to vaccine containing the same substances.
  • Participation in a clinical trial or use of an investigational product within 30 days or five times the half-life of the investigational drug -prior to receiving the first dose within this study
  • Evidence in the subject's medical history or in the medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the investigational product under investigation.
  • Any positive result for HIV1/2, HCV antibody or HBs antigen testing.
  • Pregnant or lactating females, or females who intend to become pregnant during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes
  • Subjects with inflammatory, infectious and neuroinflammatory underlying disease which could cause an expected impairment of the blood brain barrier such as meningitis, multiple sclerosis, epilepsy, or Alzheimer's.
  • Any household contact who is immunodeficient, HIV positive or pregnant
  • Working with livestock
  • Any chronic or active neurologic disorder, including migraines, seizures, and epilepsy, exclud-ing a single febrile seizure as a child
  • Known history of Guillain-Barré Syndrome
  • Active malignancy or history of metastatic or hematologic malignancy
  • Suspected or known alcohol and/or illicit drug abuse within the past 5 years
  • Moderate or severe illness and/or fever >38°C within 1 week prior to vaccination
  • Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
  • History of blood donation within 60 days of enrollment or plans to donate within the study period
  • Receipt of chronic immune suppressants or other immune-modifying drugs within 6 months of study inclusion
  • Subjects with skin lesions close to the injection site or active oral lesions will be excluded.
  • Thrombocytopenia, contraindicating intramuscular vaccination based on investigator's judgment
  • Subjects with a significant infection or known inflammation.
  • History of relevant cardiovascular disorders or evidence of hyper- or hypotension
  • Subjects who are known or suspected not to comply with the study directives.
  • Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rVSVΔ-ZEBOV-GP (BPSC1001)
Subjects will be allocated to three cohorts of 10 subjects each receiving one single vaccine injection administered as an i.m. injection.
Biological: rVSVΔ-ZEBOV-GP
single dose of rVSVΔ-ZEBOV-GP (3x10^6 pfu, 2x10^7 pfu or 3x10^5)
Other Names:
  • BPSC1001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Vaccination (day 0) to day 180

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Vaccination (day 0) to day 180
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
Vaccination (day 0) to day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

University Hospital, Geneva
Wellcome Trust
KEMRI-Wellcome Trust Collaborative Research Program
World Health Organization
Philipps University Marburg Medical Center
Albert Schweitzer Hospital
German Center for Infection Research
Institute of Tropical Medicine, University of Tuebingen
Clinical Trial Center North

Investigators

  • Study Director: Marylyn M. Addo, MD, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKE-DZIF2-VSV{Delta}G/ZEBOVGP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemorrhagic Fever, Ebola

Clinical Trials on rVSVΔ-ZEBOV-GP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe