Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02283099
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
German Center for Infection Research
Philipps University Marburg Medical Center
World Health Organization
Clinical Trial Center North
University Hospital, Geneva
Albert Schweitzer Hospital
Institute of Tropical Medicine, University of Tuebingen
Wellcome Trust
KEMRI-Wellcome Trust Collaborative Research Program
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease Intervention/treatment Phase
Hemorrhagic Fever, Ebola Biological: rVSVΔ-ZEBOV-GP Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 rVSVΔG-ZEBOV-GP (BPSC1001)
Study Start Date : November 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015


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 Name: BPSC1001




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283099


Locations
Layout table for location information
Germany
CTC North GmbH & Co. KG
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Center for Infection Research
Philipps University Marburg Medical Center
World Health Organization
Clinical Trial Center North
University Hospital, Geneva
Albert Schweitzer Hospital
Institute of Tropical Medicine, University of Tuebingen
Wellcome Trust
KEMRI-Wellcome Trust Collaborative Research Program
Investigators
Layout table for investigator information
Study Director: Marylyn M. Addo, MD Universitätsklinikum Hamburg-Eppendorf
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Agnandji ST, Huttner A, Zinser ME, Njuguna P, Dahlke C, Fernandes JF, Yerly S, Dayer JA, Kraehling V, Kasonta R, Adegnika AA, Altfeld M, Auderset F, Bache EB, Biedenkopf N, Borregaard S, Brosnahan JS, Burrow R, Combescure C, Desmeules J, Eickmann M, Fehling SK, Finckh A, Goncalves AR, Grobusch MP, Hooper J, Jambrecina A, Kabwende AL, Kaya G, Kimani D, Lell B, Lemaître B, Lohse AW, Massinga-Loembe M, Matthey A, Mordmüller B, Nolting A, Ogwang C, Ramharter M, Schmidt-Chanasit J, Schmiedel S, Silvera P, Stahl FR, Staines HM, Strecker T, Stubbe HC, Tsofa B, Zaki S, Fast P, Moorthy V, Kaiser L, Krishna S, Becker S, Kieny MP, Bejon P, Kremsner PG, Addo MM, Siegrist CA. Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe. N Engl J Med. 2016 Apr 28;374(17):1647-60. doi: 10.1056/NEJMoa1502924. Epub 2015 Apr 1.

Layout table for additonal information
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02283099    
Other Study ID Numbers: UKE-DZIF2-VSV{Delta}G/ZEBOVGP
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Ebola virus, vaccination, phase I, healthy volunteers
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Virus Diseases
Infections
Filoviridae Infections
Mononegavirales Infections