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

NCT02283099 | Completed Phase 1 DMC

• 1 other identifier: UKE-DZIF2-VSV{Delta}G/ZEBOVGP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Fever, Ebola

Keywords

Ebola virus, vaccination, phase I, healthy volunteers

Outcome Measures

Primary Outcomes (1)

• The number of adverse events associated with the rVSVΔ-ZEBOV-GP (BPSC1001) vaccine will be collected and measured

  Vaccination (day 0) to day 180

Secondary Outcomes (2)

• ZEBOV-GP-specific antibody responses

  Vaccination (day 0) to day 180

• To evaluate vaccine viremia and excretion

  Vaccination (day 0) to day 28

Study Arms (1)

rVSVΔ-ZEBOV-GP (BPSC1001)

EXPERIMENTAL

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

Interventions

rVSVΔ-ZEBOV-GP BIOLOGICAL

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

Also known as: BPSC1001

rVSVΔ-ZEBOV-GP (BPSC1001)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• German Center for Infection Research: collaborator
• Philipps University Marburg: collaborator
• World Health Organization: collaborator
• Clinical Trial Center North: collaborator
• University Hospital, Geneva: collaborator
• Albert Schweitzer Hospital: collaborator
• Institute of Tropical Medicine, University of Tuebingen: collaborator
• Wellcome Trust: collaborator
• KEMRI-Wellcome Trust Collaborative Research Program: collaborator

Study Sites (1)

CTC North GmbH & Co. KG

Hamburg, 20246, Germany

Location

Related Publications (5)

• Poetsch JH, Dahlke C, Zinser ME, Kasonta R, Lunemann S, Rechtien A, Ly ML, Stubbe HC, Krahling V, Biedenkopf N, Eickmann M, Fehling SK, Olearo F, Strecker T, Sharma P, Lang KS, Lohse AW, Schmiedel S, Becker S; VSV-Ebola Consortium (VEBCON); Addo MM. Detectable Vesicular Stomatitis Virus (VSV)-Specific Humoral and Cellular Immune Responses Following VSV-Ebola Virus Vaccination in Humans. J Infect Dis. 2019 Jan 29;219(4):556-561. doi: 10.1093/infdis/jiy565.

  PMID: 30452666 DERIVED

• Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21.

  PMID: 28647166 DERIVED

• Dahlke C, Kasonta R, Lunemann S, Krahling V, Zinser ME, Biedenkopf N, Fehling SK, Ly ML, Rechtien A, Stubbe HC, Olearo F, Borregaard S, Jambrecina A, Stahl F, Strecker T, Eickmann M, Lutgehetmann M, Spohn M, Schmiedel S, Lohse AW, Becker S, Addo MM; VEBCON Consortium. Dose-dependent T-cell Dynamics and Cytokine Cascade Following rVSV-ZEBOV Immunization. EBioMedicine. 2017 May;19:107-118. doi: 10.1016/j.ebiom.2017.03.045. Epub 2017 Apr 5.

  PMID: 28434944 DERIVED

• Medaglini D, Harandi AM, Ottenhoff TH, Siegrist CA; VSV-Ebovac Consortium. Ebola vaccine R&D: Filling the knowledge gaps. Sci Transl Med. 2015 Dec 9;7(317):317ps24. doi: 10.1126/scitranslmed.aad3106.

  PMID: 26659569 DERIVED

• 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, Lemaitre B, Lohse AW, Massinga-Loembe M, Matthey A, Mordmuller 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.

  PMID: 25830326 DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Officials

• Marylyn M. Addo, MD

  Universitätsklinikum Hamburg-Eppendorf

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 5, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)