Clinical Trial: A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccine ChAdOx2 HAV in Healthy Adult Volunteers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase I Clinical Trial to Determine the Safety and Immunogenicity of the Candidate Mycobacterium Avium Subspecies Paratuberculosis (MAP) Vaccine ChAdOx2 HAV in Healthy A

Brief Summary:

A phase I dose escalation study to assess the safety and immunogenicity of the candidate vaccine ChAdOx2 HAV in healthy volunteers.

Volunteers will be recruited and vaccinated in Oxford, England.

All vaccinations will be administered intramuscularly. Three different doses will be tested (5x10^9 vp, 2.5x10^10 vp and 5x10^10vp).

The total duration of the study will be 52 weeks from the day of enrolment for all volunteers.


Detailed Summary:

This is a phase I, open label, 3+3 dose escalation trial to assess the safety and immunogenicity of the ChAdOx2 HAV vaccine against Mycobacterium avium subspecies paratuberculosis (MAP) in healthy volunteers

There will be 3 study groups with a total of 12-18 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)

Vaccination of groups will be sequential from Group 1 to Group 3 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.


Sponsor: University of Oxford

Current Primary Outcome: Occurrence of solicited and unsolicited local and systemic adverse events [ Time Frame: up to 28 days following vaccination ]

The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. Change from baseline for safety laboratory measures will also be collected. Occurrence of serious adverse events will be collected during the whole study duration


Original Primary Outcome: Same as current

Current Secondary Outcome: Analysis of ELISPOT data to enumerate IFN-γ producing T cells [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: University of Oxford

Dates:
Date Received: January 19, 2017
Date Started: January 2017
Date Completion: April 2018
Last Updated: February 13, 2017
Last Verified: February 2017