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Ebola Virus DiseasePhase 1NCT02296983

A Study to Find Out if the New Ebola Vaccine is Safe and Stimulates Immunity That Might Protect Adults in Kilifi, Kenya.

A Phase 1 study testing VSV-ZEBOV in people with Ebola Virus Disease, run by University of Oxford at 1 site in Kenya.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Previous Ebola outbreaks have been limited to individual countries and contained by infection control activities. The current outbreak in West Africa is international, and air travel has resulted in a number of infected travellers crossing national borders. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Ebola Virus Disease
What is being tested?
VSV-ZEBOV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteKenya
Study dates
Dec 2014to Sep 2016
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

  • • Have provided written informed consent prior to screening procedures (i.e. participants must be literate).
  • Healthy adult male or non-pregnant, non-lactating female, ages 18 to 55 (inclusive) at the time of screening
  • Free of clinically significant health problems, as determined by pertinent medical history, clinical examination and blood tests at screening
  • Available, able, and willing to participate for all study visits and procedures
  • Negative pregnancy-test for female volunteers
  • Females, of non-childbearing potential who are post-menopausal (i.e. ≥ one year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
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  • Females, of childbearing potential, who are willing to use effective methods of contraception for 14 days before vaccination and 30 days after vaccination.
  • Males who are willing to use effective contraception following vaccination for a period of one week.
  • Be willing to minimize blood and body fluid exposure of others for 5 days after vaccination

Who cannot join

  • • History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions.
  • Known allergy to the components of the BPSC1001 vaccine product
  • Unable or unwilling to stay in the study area for the period of the study and comply with study procedures.
  • Ongoing participation in another clinical trial
  • Receipt of licensed vaccines within 14 days of planned study immunization (30 days for live vaccines)
  • Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test
Show all 15Show fewer
  • Any serologic evidence of hepatitis B SAg or HIV infection.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes
  • Have an 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 2 weeks prior to vaccination
  • Pregnant or lactating woman or a woman who intends to become pregnant within 30 days following vaccination.
  • Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
  • Administration of chronic (defined as more than 14 days) immunosuppressant's or other immune modifying drugs within 6 months of study entry
  • 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.

Kenya1 site

  • KEMRI Wellcome Trust Research Programme

    Kilifi, Coast, 80108

Other trials in Kenya

About this study

Official title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Volunteers in Kilifi, Kenya.

Previous Ebola outbreaks have been limited to individual countries and contained by infection control activities. The current outbreak in West Africa is international, and air travel has resulted in a number of infected travellers crossing national borders. There are currently no specific treatments generally available for Ebola and the mortality is high, particularly in countries with limited intensive care facilities. There is currently no vaccine and the personal protection required by healthcare workers treating patients is cumbersome and requires full compliance to be protective.

There is now a consortium (VEBCON collaboration) of four clinical centres (in Kenya, Gabon, Switzerland and Germany), WHO and New Link Genetics (the vaccine manufacturer) under which this study will be conducted. The investigators are conducting this trial, a Phase I, open-label, dose escalation trial, designed to establish safety, tolerability and immunogenicity of two doses of VSVΔG-ZEBOV, an Ebola Virus Vaccine Candidate for the first time in sub-Saharan African populations.

The investigators plan to vaccinate 40 volunteers in Kenya. The trial will be conducted at the KEMRI-CGMR Coast site where healthcare workers (both clinical and laboratory) will be the primary target population as they are likely to be the recipients of a protective vaccine. The investigators will vaccinate a cohort of 20 volunteers at a low dose and then vaccinate a further cohort of 20 volunteers at full dose. Each volunteer will receive one dose of the vaccine. The investigators will follow them up for a period of one year looking to their safety and immunogenicity endpoints.

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
VSV-ZEBOV
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.

  • VSV-ZEBOVBiological

    Also called BSPSC1001

    VSV-ZEBOV

Study groups in NCT02296983
Study groupRoleWhat they receive
Low dose armExperimentalThe low dose cohort will receive an intramuscular (deltoid) injection of 3x106 pfu of VSV-ZEBOV vaccine.
Receives: Biological: VSV-ZEBOV
Full dose armExperimentalThe full dose cohort will receive an intramuscular (deltoid) injection1x107 pfu of VSV-ZEBOV vaccine.
Receives: Biological: VSV-ZEBOV

What is being measured

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

  1. The nature, frequency, and severity of adverse events (AEs) and/or serious adverse events (SAEs) with causal link to the study intervention

    To evaluate the safety and tolerability of two different doses of VSVΔG-ZEBOV vaccine

    Measured: Days 0-30

Secondary outcomes (9)

  1. Incidence and severity of local and systemic reactogenicity signs and symptoms

    Measured: Day 0-28

  2. Incidence of unsolicited adverse events (AEs)

    Measured: Days 0-28

  3. Incidence of serious adverse events (SAEs)

    Measured: Days 0-365

  4. Distribution of values of safety laboratory measures at baseline and at follow-up visits post-vaccination

    The distribution of values of safety laboratory measures will include the assessment of complete blood count (with differential white cell count), creatinine and alanine transaminase levels at baseline and day 7 and 30 following vaccine administration.

    Measured: Day 0-30

  5. Persistence of titres of ZEBOV-specific IgG antibodies

    Measured: 0-180 days

  6. Detection, magnitude and duration of VSV-ZEBOV viraemia and shedding

    The detection and concentration (copies/ml) of rVSV (viral shedding) will determined in blood, urine, or saliva samples to evaluate VSV vaccine viraemia following vaccine administration. The duration will be determined by the last timepoint with detectable viraemia.This is a composite measure.

    Measured: Day 1, 3 and 7

  7. Titres of neutralising ZEBOV-specific IgG antibodies

    Measured: Days 7, 30, 60, 90, 180 and 365

  8. Pattern of ZEBOV specific T cell responses

    Measured: Days 7, 30, 90, 180 and 365

  9. Titers of ZEBOV-specific IgG antibodies

    Important for dose selection

    Measured: Days 0-28

Timeline

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

  1. First posted21 Nov 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionFeb 2016
  4. Study completionSep 2016 (estimated)

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02296983
Sponsor's protocol ID
OXTREC 71-14
Other IDs
SSC 2976
Status last verified
Apr 2016
First submitted
11 Nov 2014
Last updated
14 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Huttner A, Agnandji ST, Combescure C, Fernandes JF, Bache EB, Kabwende L, Ndungu FM, Brosnahan J, Monath TP, Lemaitre B, Grillet S, Botto M, Engler O, Portmann J, Siegrist D, Bejon P, Silvera P, Kremsner P, Siegrist CA; VEBCON; VSV-EBOVAC; VSV-EBOPLUS Consortia. Determinants of antibody persistence across doses and continents after single-dose rVSV-ZEBOV vaccination for Ebola virus disease: an observational cohort study. Lancet Infect Dis. 2018 Jul;18(7):738-748. doi: 10.1016/S1473-3099(18)30165-8. Epub 2018 Apr 5.

    PubMed 29627147

  • 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

  • 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 VSV-ZEBOV in people with Ebola Virus Disease, run by University of Oxford at 1 site in Kenya.

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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 14 Apr 2016. 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 Kenya. 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?

Results are not available in the source record.

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 nature, frequency, and severity of adverse events (AEs) and/or serious adverse events (SAEs) with causal link to the study intervention (time frame: Days 0-30). 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 NCT02296983, which also lists 4 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 14 Apr 2016.

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