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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by University of Oxford
Sponsor:
Collaborators:
Wellcome Trust
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT02240875
First received: September 10, 2014
Last updated: July 12, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Ebola
Ebola Zaire
Biological: cAd3-EBO Z at 1 x 10^10 vp
Biological: cAd3-EBO Z at 2.5 x 10^10 vp
Biological: cAd3-EBO Z at 5 x 10^10 vp
Biological: 4.4x10^8 TCID50s MVA-BN® Filo
Biological: 2.2x10^8 TCID50s MVA-BN® Filo
Biological: 4.4 x 10^7 TCID50s MVA-BN® Filo
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Safety and tolerability of the Ebola Zaire vaccine cAd3-EBO Z when administered to healthy volunteers at 3 doses [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.


Secondary Outcome Measures:
  • Cellular and humoral immunogenicity of the Ebola Zaire vaccine cAd3-EBO Z when administered to healthy volunteers at 3 doses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 92
Study Start Date: September 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Single dose of cAd3-EBO Z at 1 x 10^10 vp intramuscularly
Biological: cAd3-EBO Z at 1 x 10^10 vp
Low dose cAd3-EBO Z
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
Biological: cAd3-EBO Z at 1 x 10^10 vp
Low dose cAd3-EBO Z
Biological: 4.4x10^8 TCID50s MVA-BN® Filo
High dose 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
Biological: cAd3-EBO Z at 1 x 10^10 vp
Low dose cAd3-EBO Z
Biological: 2.2x10^8 TCID50s MVA-BN® Filo
Low dose MVA-BN® Filo
Experimental: Group 2
Single dose of cAd3-EBO Z at 2.5 x 10^10 vp intramuscularly
Biological: cAd3-EBO Z at 2.5 x 10^10 vp
Medium dose cAd3-EBO Z
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
Biological: cAd3-EBO Z at 2.5 x 10^10 vp
Medium dose cAd3-EBO Z
Biological: 4.4x10^8 TCID50s MVA-BN® Filo
High dose 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
Biological: cAd3-EBO Z at 2.5 x 10^10 vp
Medium dose cAd3-EBO Z
Biological: 2.2x10^8 TCID50s MVA-BN® Filo
Low dose MVA-BN® Filo
Experimental: Group 3
Single dose of cAd3-EBO Z at 5 x 10^10 vp intramuscularly
Biological: cAd3-EBO Z at 5 x 10^10 vp
High dose cAd3-EBO Z
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
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
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
Biological: cAd3-EBO Z at 5 x 10^10 vp
High dose cAd3-EBO Z
Biological: 2.2x10^8 TCID50s MVA-BN® Filo
Low dose 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
Biological: cAd3-EBO Z at 2.5 x 10^10 vp
Medium dose cAd3-EBO Z
Biological: 2.2x10^8 TCID50s MVA-BN® Filo
Low dose 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
Biological: cAd3-EBO Z at 2.5 x 10^10 vp
Medium dose cAd3-EBO Z
Biological: 2.2x10^8 TCID50s MVA-BN® Filo
Low dose 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
Biological: cAd3-EBO Z at 2.5 x 10^10 vp
Medium dose cAd3-EBO Z
Biological: 4.4 x 10^7 TCID50s MVA-BN® Filo
Very low dose 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
Biological: cAd3-EBO Z at 2.5 x 10^10 vp
Medium dose cAd3-EBO Z
Biological: 4.4 x 10^7 TCID50s MVA-BN® Filo
Very low dose MVA-BN® Filo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02240875

Contacts
Contact: Volunteer Coordinator 01865 857406 vaccinetrials@ndm.ox.ac.uk

Locations
United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Contact: Volunteer Coordinator    01865 857406    vaccinetrials@ndm.ox.ac.uk   
Principal Investigator: Adrian V S Hill         
Sponsors and Collaborators
University of Oxford
Wellcome Trust
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Adrian V S Hill University of Oxford
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02240875     History of Changes
Other Study ID Numbers: EBL01  2014-003518-10 
Study First Received: September 10, 2014
Last Updated: July 12, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
Ebola
Zaire

Additional relevant MeSH terms:
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Virus Diseases
Filoviridae Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on August 25, 2016