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EbolaPhase 1NCT02240875

A Study to Assess New Ebola Vaccines, cAd3-EBO Z and MVA-BN® Filo

A Phase 1 study testing cAd3-EBO Z at 1 x 10^10 vp, cAd3-EBO Z at 2.5 x 10^10 vp and cAd3-EBO Z at 5 x 10^10 vp in people with Ebola and Ebola Zaire, run by University of Oxford at 1 site in United Kingdom.

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 purpose of this study is to assess two new Ebola vaccines: cAd3-EBO Z at 3 different doses, and a second vaccine, MVA-BN® Filo, at 3 different doses. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Ebola, Ebola Zaire
What is being tested?
cAd3-EBO Z at 1 x 10^10 vp, cAd3-EBO Z at 2.5 x 10^10 vp and cAd3-EBO Z at 5 x 10^10 vp
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteUnited Kingdom
Study dates
17 Sep 2014to 22 Aug 2017
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults aged 18 to 50 years
  • Able and willing (in the Investigator's opinion) to comply with all study requirements
  • Willing to allow the investigators to discuss the volunteer's medical history with their general practitioner (GP)
  • For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination
  • Agreement to refrain from blood donation during the course of the study
  • Provide written informed consent

Who cannot join

  • Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
  • Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus vectored vaccine or any other investigational vaccine likely to impact on interpretation of the trial data
  • Receipt of any live, attenuated vaccine within 28 days prior to enrolment
  • Receipt of any subunit or killed vaccine within 14 days prior to enrolment
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
Show all 25Show fewer
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, (e.g. egg products) including urticaria, respiratory difficulty or abdominal pain
  • Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  • Any history of anaphylaxis in reaction to vaccination
  • Pregnancy, lactation or willingness/intention to become pregnant during the study
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of serious psychiatric condition
  • Poorly controlled asthma or thyroid disease
  • Seizure in the past 3 years or treatment for seizure disorder in the past 3 years
  • Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture
  • Any other serious chronic illness requiring hospital specialist supervision
  • Current anti-tuberculosis prophylaxis or therapy
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
  • Suspected or known injecting drug abuse in the 5 years preceding enrolment
  • Seropositive for hepatitis B surface antigen (HBsAg)
  • Seropositive for hepatitis C virus (antibodies to HCV)
  • Travel to a Ebola or Marburg endemic region during the study period or within the previous six months
  • Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis (see Appendix A and Appendix B)
  • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
  • Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford

    Oxford, Oxfordshire, OX3 7LE

Other trials in United Kingdom

About this study

Official title: A Phase Ia, Dose-Escalating, Safety and Immunogenicity Trial of the Monovalent Zaire Ebola Viral Vector Candidate Vaccine cAd3-EBO Z and the Heterologous Prime-boost Candidate Vaccine Regimen cAd3-EBO Z and MVA-BN® Filo in Healthy UK Adults

The purpose of this study is to assess two new Ebola vaccines: cAd3-EBO Z at 3 different doses, and a second vaccine, MVA-BN® Filo, at 3 different doses. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. The investigators will do this by giving volunteers a either one or two vaccinations, doing blood and saliva tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use either of these vaccines in humans. We plan to recruit a total of 92 volunteers to be vaccinated.

Read the detailed description

Long- term immunology follow-up: In order to assess the durability of vaccine induced immunogenicity, all vaccinated subjects will be invited back to attend a maximum of 3 further optional follow up visits at least 12 months after their final vaccination. The 3 visits will have a minimum interval of 3 months between them, and the final visit must take place no longer than 12 months after the first optional visit.

Volunteers who attend these visits will be asked about occurrence of any SAEs during the intervening period. SAE data for this period will not be collected in those volunteers who decline to attend these additional visits.

Conditions
Ebola, Ebola Zaire
Being tested
cAd3-EBO Z at 1 x 10^10 vp, cAd3-EBO Z at 2.5 x 10^10 vp, cAd3-EBO Z at 5 x 10^10 vp, 4.4x10^8 TCID50s MVA-BN® Filo, 2.2x10^8 TCID50s MVA-BN® Filo
Keywords
Ebola, Zaire
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.

  • cAd3-EBO Z at 1 x 10^10 vpBiological

    Low dose cAd3-EBO Z

  • cAd3-EBO Z at 2.5 x 10^10 vpBiological

    Medium dose cAd3-EBO Z

  • cAd3-EBO Z at 5 x 10^10 vpBiological

    High dose cAd3-EBO Z

  • 4.4x10^8 TCID50s MVA-BN® FiloBiological

    High dose MVA-BN® Filo

  • 2.2x10^8 TCID50s MVA-BN® FiloBiological

    Low dose MVA-BN® Filo

  • 4.4 x 10^7 TCID50s MVA-BN® FiloBiological

    Very low dose MVA-BN® Filo

Study groups in NCT02240875
Study groupRoleWhat they receive
Group 1ExperimentalSingle dose of cAd3-EBO Z at 1 x 10^10 vp intramuscularly
Receives: Biological: cAd3-EBO Z at 1 x 10^10 vp
Group 1bExperimentalSingle dose of cAd3-EBO Z at 1 x 10^10 vp intramuscularly, followed by 4.4x10^8 TCID50s MVA-BN® Filo
Receives: Biological: cAd3-EBO Z at 1 x 10^10 vp; Biological: 4.4x10^8 TCID50s MVA-BN® Filo
Group 1cExperimentalSingle dose of cAd3-EBO Z at 1 x 10^10 vp intramuscularly, followed by 2.2x10^8 TCID50s MVA-BN® Filo
Receives: Biological: cAd3-EBO Z at 1 x 10^10 vp; Biological: 2.2x10^8 TCID50s MVA-BN® Filo
Group 2ExperimentalSingle dose of cAd3-EBO Z at 2.5 x 10^10 vp intramuscularly
Receives: Biological: cAd3-EBO Z at 2.5 x 10^10 vp
Group 2bExperimentalSingle dose of cAd3-EBO Z at 2.5 x 10^10 vp intramuscularly, followed by 4.4x10^8 TCID50s MVA-BN® Filo
Receives: Biological: cAd3-EBO Z at 2.5 x 10^10 vp; Biological: 4.4x10^8 TCID50s MVA-BN® Filo
Group 2cExperimentalSingle dose of cAd3-EBO Z at 2.5 x 10^10 vp intramuscularly, followed by 2.2x10^8 TCID50s MVA-BN® Filo
Receives: Biological: cAd3-EBO Z at 2.5 x 10^10 vp; Biological: 2.2x10^8 TCID50s MVA-BN® Filo
Group 3ExperimentalSingle dose of cAd3-EBO Z at 5 x 10^10 vp intramuscularly
Receives: Biological: cAd3-EBO Z at 5 x 10^10 vp
Group 3bExperimentalSingle dose of cAd3-EBO Z at 5 x 10^10 vp intramuscularly, followed by 4.4x10^8 TCID50s MVA-BN® Filo
Receives: Biological: cAd3-EBO Z at 5 x 10^10 vp; Biological: 4.4x10^8 TCID50s MVA-BN® Filo
Group 3cExperimentalSingle dose of cAd3-EBO Z at 5 x 10^10 vp intramuscularly, followed by 2.2x10^8 TCID50s MVA-BN® Filo
Receives: Biological: cAd3-EBO Z at 5 x 10^10 vp; Biological: 2.2x10^8 TCID50s MVA-BN® Filo
Group 4ExperimentalSingle dose of cAd3-EBO Z at 2.5 x 10^10 vp intramuscularly at day 0, followed by 2.2 x 10^8 TCID50s MVA-BN® Filo at day 7
Receives: Biological: cAd3-EBO Z at 2.5 x 10^10 vp; Biological: 2.2x10^8 TCID50s MVA-BN® Filo
Group 5ExperimentalSingle dose of cAd3-EBO Z at 2.5 x 10^10 vp intramuscularly at day 0, followed by 2.2 x 10^8 TCID50s MVA-BN® Filo at day 14
Receives: Biological: cAd3-EBO Z at 2.5 x 10^10 vp; Biological: 2.2x10^8 TCID50s MVA-BN® Filo
Group 6ExperimentalSingle dose of cAd3-EBO Z at 2.5 x 10^10 vp intramuscularly at day 0, followed by 4.4 x 10^7 TCID50s MVA-BN® Filo at day 7
Receives: Biological: cAd3-EBO Z at 2.5 x 10^10 vp; Biological: 4.4 x 10^7 TCID50s MVA-BN® Filo
Group 7ExperimentalSingle dose of cAd3-EBO Z at 2.5 x 10^10 vp intramuscularly at day 0, followed by 4.4 x 10^7 TCID50s MVA-BN® Filo at day 14
Receives: Biological: cAd3-EBO Z at 2.5 x 10^10 vp; Biological: 4.4 x 10^7 TCID50s MVA-BN® Filo

What is being measured

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

  1. Safety and tolerability of the Ebola Zaire vaccine cAd3-EBO Z when administered to healthy volunteers at 3 doses

    The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.

    Measured: 6 months

Secondary outcomes (1)

  1. Cellular and humoral immunogenicity of the Ebola Zaire vaccine cAd3-EBO Z when administered to healthy volunteers at 3 doses

    The primary immunogenicity outcome measures are ELISA and neutralization antigen-specific assays for antibody responses and intracellular cytokine staining (ICS) assay for T cell responses.

    Measured: 6 months

Timeline

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

  1. First posted16 Sep 2014 (estimated)
  2. Study start17 Sep 2014
  3. Primary completion22 Aug 2017
  4. Study completion22 Aug 2017

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
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02240875
Sponsor's protocol ID
EBL01
Other IDs
2014-003518-10, 2014
Status last verified
Jul 2018
First submitted
10 Sep 2014
Last updated
6 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Lambe T, Rampling T, Samuel D, Bowyer G, Ewer KJ, Venkatraman N, Edmans M, Dicks S, Hill AV, Tedder RS, Gilbert SC. Detection of Vaccine-Induced Antibodies to Ebola Virus in Oral Fluid. Open Forum Infect Dis. 2016 Feb 22;3(1):ofw031. doi: 10.1093/ofid/ofw031. eCollection 2016 Jan.

    PubMed 27004234

  • Ewer K, Rampling T, Venkatraman N, Bowyer G, Wright D, Lambe T, Imoukhuede EB, Payne R, Fehling SK, Strecker T, Biedenkopf N, Krahling V, Tully CM, Edwards NJ, Bentley EM, Samuel D, Labbe G, Jin J, Gibani M, Minhinnick A, Wilkie M, Poulton I, Lella N, Roberts R, Hartnell F, Bliss C, Sierra-Davidson K, Powlson J, Berrie E, Tedder R, Roman F, De Ryck I, Nicosia A, Sullivan NJ, Stanley DA, Mbaya OT, Ledgerwood JE, Schwartz RM, Siani L, Colloca S, Folgori A, Di Marco S, Cortese R, Wright E, Becker S, Graham BS, Koup RA, Levine MM, Volkmann A, Chaplin P, Pollard AJ, Draper SJ, Ballou WR, Lawrie A, Gilbert SC, Hill AV. A Monovalent Chimpanzee Adenovirus Ebola Vaccine Boosted with MVA. N Engl J Med. 2016 Apr 28;374(17):1635-46. doi: 10.1056/NEJMoa1411627. Epub 2015 Jan 28.

    PubMed 25629663

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cAd3-EBO Z at 1 x 10^10 vp, cAd3-EBO Z at 2.5 x 10^10 vp and cAd3-EBO Z at 5 x 10^10 vp in people with Ebola and Ebola Zaire, run by University of Oxford at 1 site in United Kingdom.

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 6 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 6 Jul 2018. 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 United Kingdom. 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?

Safety and tolerability of the Ebola Zaire vaccine cAd3-EBO Z when administered to healthy volunteers at 3 doses (time frame: 6 months). 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 NCT02240875, which also lists 2 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 6 Jul 2018.

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