Safety and immunogenicity of novel routes of administration for ChAd63 and MVA encoding ME-TRAP

Group 1 consists of 3 volunteers receiving i.v. ChAd63 ME-TRAP at the dose of 5×10^8 vp.
Group 2 consists of 3 volunteers receiving i.v. ChAd63 ME-TRAP at the dose of 5×10^9 vp.
Group 3 consists of 9 volunteers receiving i.v. ChAd63 ME-TRAP at the dose of 5×10^10vp.
Group 4 consists of 3 volunteers receiving s.c. ChAd63 ME-TRAP at the dose of 5×10^10 vp.
Group 5 consists of 3 volunteers receiving s.c. ChAd63 ME-TRAP at the dose of 2×10^11 vp.
Group 6 consists of 3 volunteers receiving i.v. MVA ME-TRAP at the dose of 2×10^6 pfu.
Group 7 consists of 3 volunteers receiving i.v. MVA ME-TRAP at the dose of 2×10^7 pfu.
Group 8 consists of 3-6 volunteers receiving i.v. MVA ME-TRAP at the dose of 2×10^8 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 a 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 enroll the final three volunteers on the basis of the immunology data – and whether a 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 a 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.

Study type: Interventional
Enrollment: 26 participants
Primary purpose: Prevention
Allocation:Non-Randomized
Interventional Model: Parallel assignment
Masking :Open label
NCT number: NCT03084289
Phase: Phase I

Clinical trial registration

Vaccines

Mar 2017 — Jul 2020

United Kingdom