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Hemorrhagic Fever, EbolaPhase 1NCT02283099

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

A Phase 1 study testing rVSVΔ-ZEBOV-GP in people with Hemorrhagic Fever, Ebola, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Hemorrhagic Fever, Ebola
What is being tested?
rVSVΔ-ZEBOV-GP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGermany
Study dates
Nov 2014to Nov 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • CTC North GmbH & Co. KG

    Hamburg, 20246

Other trials in Germany

About this study

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)

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.

Read the 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.

Being tested
rVSVΔ-ZEBOV-GP
Keywords
Ebola virus, vaccination, phase I, healthy volunteers
Medical subject headings
Hemorrhagic Fever, Ebola

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rVSVΔ-ZEBOV-GPBiological

    Also called BPSC1001

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

Study groups in NCT02283099
Study groupRoleWhat they receive
rVSVΔ-ZEBOV-GP (BPSC1001)ExperimentalSubjects will be allocated to three cohorts of 10 subjects each receiving one single vaccine injection administered as an i.m. injection.
Receives: Biological: rVSVΔ-ZEBOV-GP

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Vaccination (day 0) to day 180

Secondary outcomes (2)

  1. ZEBOV-GP-specific antibody responses

    Humoral immunity: Magnitude of ZEBOV-GP-specific antibody responses as assayed by ELISA in a centralized laboratory.

    Measured: Vaccination (day 0) to day 180

  2. To evaluate vaccine viremia and excretion

    Vaccine viremia and viral shedding: concentration of rVSV in peripheral blood, urine and saliva as detected by qRT-PCR

    Measured: Vaccination (day 0) to day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02283099
Sponsor's protocol ID
UKE-DZIF2-VSV{Delta}G/ZEBOVGP
Status last verified
May 2017
First submitted
31 Oct 2014
Last updated
30 May 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 30452666

  • 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.

    PubMed 28647166

  • 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.

    PubMed 28434944

  • 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.

    PubMed 26659569

  • 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.

    PubMed 25830326

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing rVSVΔ-ZEBOV-GP in people with Hemorrhagic Fever, Ebola, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02283099, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.

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