A Study to Assess the Safety and Immunogenicity of a Candidate Malaria Vaccine Using Novel Routes of Administration
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and immunogenicity of novel routes of
      administration of the candidate malaria vaccines ChAd63 encoding ME-TRAP and MVA encoding
      ME-TRAP.

      30-33 Healthy adult volunteers will be recruited in Oxford.

      All vaccinations will be administered intravenously or subcutaneously. Each volunteer will
      receive a single vaccination of ChAd63 ME-TRAP or MVA ME-TRAP at different doses depending on
      the group.
    

Detailed description: 
      Group1 consists of 3 volunteers receiving i.v. ChAd63 ME-TRAP at the dose of 5x10^8 vp.

      Group 2 consists of 3 volunteers receiving i.v. ChAd63 ME-TRAP at the dose of 5x10^9 vp.

      Group 3 consists of 9 volunteers receiving i.v. ChAd63 ME-TRAP at the dose of 5x10^10vp.

      Group 4 consists of 3 volunteers receiving s.c. ChAd63 ME-TRAP at the dose of 5x10^10 vp.

      Group 5 consists of 3 volunteers receiving s.c. ChAd63 ME-TRAP at the dose of 2x10^11 vp.

      Group 6 consists of 3 volunteers receiving i.v. MVA ME-TRAP at the dose of 2x10^6 pfu.

      Group 7 consists of 3 volunteers receiving i.v. MVA ME-TRAP at the dose of 2x10^7 pfu.

      Group 8 consists of 3-6 volunteers receiving i.v. MVA ME-TRAP at the dose of 2x10^8 pfu.

      The first Group 1 volunteer to receive intravenous ChAd63 ME-TRAP will be vaccinated alone.
      Safety data for the first 72 hours following vaccination must be satisfactorily reviewed
      before the remaining group 1 volunteers are vaccinated. The safety data for the first 72
      hours following vaccination for all the volunteers in the group will again be reviewed before
      the first volunteer in the higher dose group 2 is vaccinated. Safety data for the first 72
      hours following vaccination of this volunteer must be satisfactorily reviewed before the
      remaining group 2 volunteers are vaccinated. Similarly the safety data for the first 72 hours
      following vaccination for all the volunteers in this group will again be reviewed before the
      first volunteer in the higher dose group 3 is vaccinated. Once there is satisfactory review
      of the safety data of the first 72 hours post vaccination for this volunteer, the remaining
      group 3 volunteers will be enrolled to receive IV vaccination.

      An identical process will be followed for the enrolment of groups 6 - 8 receiving MVA ME-TRAP
      intravenously. Once three group 8 volunteers have received vaccination and there has been a
      satisfactory safety review at 72 hours, the chief investigator will make a decision as to
      whether or not to enrol the final three volunteers on the basis of the immunology data - and
      whether further determination of immunogenicity is needed.

      In parallel with Group 1, the first Group 4 volunteer to receive subcutaneous Chad63 ME-TRAP
      will be vaccinated alone. Safety data for the first 72 hours following vaccination must be
      satisfactorily reviewed before the remaining group 4 volunteers are vaccinated. The safety
      data for the first 72 hours following vaccination for all the volunteers in the group will
      again be reviewed before the first volunteer in the higher dose group 5 is vaccinated. Once
      there is satisfactory review of the safety data of the first 72 hours post vaccination for
      this volunteer, the remaining group 5 volunteers will be enrolled to receive SC vaccination.
    

Intervention name(s): ChAd63-METRAP; MVA ME-TRAP
Intervention type(s): Biological; Biological
Intervention description(s): The candidate vaccine applicable to the clinical trial is the Chimpanzee adenovirus 63 expressing Multiple epitopes and thrombospondin related adhesion protein.; The candidate vaccine applicable to the clinical trial is the Modified Vaccinia virus Ankara expressing Multiple epitopes and thrombospondin related adhesion protein.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention