NCT03027193

A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccines ChAdOx2 HAV and MVA in Healthy Adult Volunteers

A Phase I Clinical Trial to Determine the Safety and Immunogenicity of the Candidate Mycobacterium Avium Subspecies Paratuberculosis (MAP) Vaccines ChAdOx2 HAV and MVA HAV in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A phase I dose escalation study to assess the safety and immunogenicity of the candidate vaccines ChAdOx2 HAV and MVA HAV in healthy volunteers. Volunteers will be recruited and vaccinated in Oxford, England. All vaccinations will be administered intramuscularly. Three different doses of the ChAdOx2 HAV will be tested (5x10\^9 vp, 2.5x10\^10 vp and 5x10\^10vp). MVA HAV will be assessed at 2 different doses (5x10\^7 and 2x10\^8 pfu) The total duration of the study will be 52 weeks from the day of enrolment for volunteers receiving ChAdOx2 HAV only, 12 weeks for volunteers receiving MVA HAV only and 20 weeks for volunteers receiving ChAdOx2 HAV and MVA HAV.

Detailed description

This is a phase I, open label, dose escalation trial to assess the safety and immunogenicity of the ChAdOx2 and MVA HAV vaccines against Mycobacterium avium subspecies paratuberculosis (MAP) in healthy volunteers There will be 5 study groups with a total of 28 volunteers. ChAdOx2 HAV will be administered intramuscularly as a single vaccination at 3 different doses: 5x10\^9 vp (group 1), 2.5x10\^10 (group 2) and 5x10\^10 vp (group 3) and as a prime vaccine in group 6 (prime/boost group). MVA HAV will be administered intramuscularly as a single vaccination at 2 different doses: 5x10\^7 pfu (group 4), 2x10\^8 pfu (group 5) and as a boost vaccine in group 6 (prime/boost group) Vaccination of groups will be sequential from Group 1 to Group 6 with interim safety reviews prior to dose escalation Volunteers will be recruited and undergo screening visits, vaccination and clinic visits post-vaccination at the trial site. Blood samples for safety and immunology purposes will be performed on the visit time points indicated in the schedule of attendances. Safety will be assessed by the frequency, incidence and nature of adverse events and serious adverse events arising during the study.

Conditions

• Crohn Disease
• Mycobacterium Avium Subspecies Paratuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx2 HAV	The ChAdOx2 HAV vaccine consists of the replication-deficient simian adenovirus vector ChAdOx2, containing the Mycobacterium avium subspecies paratuberculosis (MAP) antigens
BIOLOGICAL	MVA HAV	The MVA HAV vaccine consists of the replication deficient modified vaccinia virus Ankara (MVA) containing the Mycobacterium avium subspecies paratuberculosis (MAP) antigens.

Timeline

• Start date: 2017-03-15
• Primary completion: 2020-01-16
• Completion: 2020-01-16
• First posted: 2017-01-23
• Last updated: 2020-02-25

Locations

1 site across 1 country: United Kingdom