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

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: NCT02240875
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
Wellcome Trust
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE September 10, 2014
First Posted Date  ICMJE September 16, 2014
Last Update Posted Date July 6, 2018
Actual Study Start Date  ICMJE September 17, 2014
Actual Primary Completion Date August 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
Safety and tolerability of the Ebola Zaire vaccine cAd3-EBO Z when administered to healthy volunteers at 3 doses [ Time Frame: 6 months ]
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
Cellular and humoral immunogenicity of the Ebola Zaire vaccine cAd3-EBO Z when administered to healthy volunteers at 3 doses [ Time Frame: 6 months ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess New Ebola Vaccines, cAd3-EBO Z and MVA-BN® Filo
Official Title  ICMJE 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
Brief 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. 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Ebola
  • Ebola Zaire
Intervention  ICMJE
  • Biological: cAd3-EBO Z at 1 x 10^10 vp
    Low dose cAd3-EBO Z
  • Biological: cAd3-EBO Z at 2.5 x 10^10 vp
    Medium dose cAd3-EBO Z
  • Biological: cAd3-EBO Z at 5 x 10^10 vp
    High dose cAd3-EBO Z
  • Biological: 4.4x10^8 TCID50s MVA-BN® Filo
    High dose MVA-BN® Filo
  • Biological: 2.2x10^8 TCID50s MVA-BN® Filo
    Low dose MVA-BN® Filo
  • Biological: 4.4 x 10^7 TCID50s MVA-BN® Filo
    Very low dose MVA-BN® Filo
Study Arms  ICMJE
  • Experimental: Group 1
    Single dose of cAd3-EBO Z at 1 x 10^10 vp intramuscularly
    Intervention: Biological: cAd3-EBO Z at 1 x 10^10 vp
  • Experimental: Group 1b
    Single dose of cAd3-EBO Z at 1 x 10^10 vp intramuscularly, followed by 4.4x10^8 TCID50s MVA-BN® Filo
    Interventions:
    • Biological: cAd3-EBO Z at 1 x 10^10 vp
    • Biological: 4.4x10^8 TCID50s MVA-BN® Filo
  • Experimental: Group 1c
    Single dose of cAd3-EBO Z at 1 x 10^10 vp intramuscularly, followed by 2.2x10^8 TCID50s MVA-BN® Filo
    Interventions:
    • Biological: cAd3-EBO Z at 1 x 10^10 vp
    • Biological: 2.2x10^8 TCID50s MVA-BN® Filo
  • Experimental: Group 2
    Single dose of cAd3-EBO Z at 2.5 x 10^10 vp intramuscularly
    Intervention: Biological: cAd3-EBO Z at 2.5 x 10^10 vp
  • Experimental: Group 2b
    Single dose of cAd3-EBO Z at 2.5 x 10^10 vp intramuscularly, followed by 4.4x10^8 TCID50s MVA-BN® Filo
    Interventions:
    • Biological: cAd3-EBO Z at 2.5 x 10^10 vp
    • Biological: 4.4x10^8 TCID50s MVA-BN® Filo
  • Experimental: Group 2c
    Single dose of cAd3-EBO Z at 2.5 x 10^10 vp intramuscularly, followed by 2.2x10^8 TCID50s MVA-BN® Filo
    Interventions:
    • Biological: cAd3-EBO Z at 2.5 x 10^10 vp
    • Biological: 2.2x10^8 TCID50s MVA-BN® Filo
  • Experimental: Group 3
    Single dose of cAd3-EBO Z at 5 x 10^10 vp intramuscularly
    Intervention: Biological: cAd3-EBO Z at 5 x 10^10 vp
  • Experimental: Group 3b
    Single dose of cAd3-EBO Z at 5 x 10^10 vp intramuscularly, followed by 4.4x10^8 TCID50s MVA-BN® Filo
    Interventions:
    • Biological: cAd3-EBO Z at 5 x 10^10 vp
    • Biological: 4.4x10^8 TCID50s MVA-BN® Filo
  • Experimental: Group 3c
    Single dose of cAd3-EBO Z at 5 x 10^10 vp intramuscularly, followed by 2.2x10^8 TCID50s MVA-BN® Filo
    Interventions:
    • Biological: cAd3-EBO Z at 5 x 10^10 vp
    • Biological: 2.2x10^8 TCID50s MVA-BN® Filo
  • Experimental: Group 4
    Single 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
    Interventions:
    • Biological: cAd3-EBO Z at 2.5 x 10^10 vp
    • Biological: 2.2x10^8 TCID50s MVA-BN® Filo
  • Experimental: Group 5
    Single 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
    Interventions:
    • Biological: cAd3-EBO Z at 2.5 x 10^10 vp
    • Biological: 2.2x10^8 TCID50s MVA-BN® Filo
  • Experimental: Group 6
    Single 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
    Interventions:
    • Biological: cAd3-EBO Z at 2.5 x 10^10 vp
    • Biological: 4.4 x 10^7 TCID50s MVA-BN® Filo
  • Experimental: Group 7
    Single 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
    Interventions:
    • Biological: cAd3-EBO Z at 2.5 x 10^10 vp
    • Biological: 4.4 x 10^7 TCID50s MVA-BN® Filo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2018)
91
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2014)
60
Actual Study Completion Date  ICMJE August 22, 2017
Actual Primary Completion Date August 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02240875
Other Study ID Numbers  ICMJE EBL01
2014-003518-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE
  • Wellcome Trust
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Adrian V Hill University of Oxford
PRS Account University of Oxford
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP