Evaluation of a New Ebola Vaccine Using a Short-interval Prime-boost Vaccination
Condition: Ebola Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Intervention: ChAd3-EBO Z; MVA-EBO Z
Intervention description: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein; This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ebola; vaccine; safety; immunogenicity

Summary:

      This is a clinical trial in which healthy volunteers will be administered two experimental
      Ebola vaccines: ChAd3-EBO Z and MVA-EBO Z. Two groups of volunteers will be vaccinated with
      both vaccines one after the other in a prime/boost regimen.

      All ChAd3-EBO Z doses are 2.5 x 10^10 - 3.7 x 10^10 vp and all MVA-EBO Z doses are 1.0 x 10^8
      pfu.

      All volunteers will receive a ChAd3-EBO Z priming vaccine and a MVA-EBO Z boosting vaccine 7
      days later.

      The site of administration of the MVA-EBO Z vaccine differs between the two groups:

      Group 1 will receive the MVA-EBO Z vaccine in the same arm as the ChAd3-EBO Z vaccine.

      Group 2 will receive the MVA-EBO Z vaccine in the opposite arm from the ChAd3-EBO Z vaccine.

      The study will assess the safety of the vaccinations, and the immune responses to
      vaccination. Immune responses are measured by tests on blood samples.

      The ChAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from
      viruses which are modified so that they cannot multiply. The viruses have extra DNA in them
      so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that
      the immune system builds a response to Ebola without having been infected by it.

      Healthy volunteers will be recruited in Dakar, Senegal. The study will be funded by GSK.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults aged 18 to 50 years

          -  Able and willing (in the Investigator's opinion) to comply with all study requirements

          -  For females only, willingness to practice continuous effective contraception (see
             section 6.4.3) 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 participation during the study
             period

          -  Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus
             vectored vaccine, an MVA 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 current or previous psychiatric illness.

          -  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 IM injections or venepuncture

          -  Any other serious chronic illness

          -  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)

          -  History of contact with suspected, probable or confirmed cases of Ebola in the
             previous 21 days

          -  Any clinically significant abnormal finding on screening biochemistry or haematology
             blood tests or urinalysis (see Appendix A & 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