A phase 1b clinical trial to determine the safety, tolerability and immunogenicity of simian adenovirus and poxvirus vectored vaccines against a Mycobacterium avium complex subspecies in patients with active Crohn's disease.

ABSTRACT:

Background

Crohn's Disease (CD) is a chronic, debilitating condition hypothesised to be associated with Mycobacterium avium ssp paratuberculosis (MAP) infection. It is the causative pathogen of the granulomatous inflammatory enteritis in ruminants, Johne's Disease. A developing treatment approach is utilising heterologous prime-boost viral vectored vaccines. We report a Phase 1b dose-escalation trial to determine the safety, tolerability and immunogenicity of candidate recombinant ChAdOx2 and MVA vectored vaccines against MAP in patients with CD.

Methods

28 patients with mild to moderate CD, aged 18-50, were randomly allocated into 5 groups. Group 1 and 2 were vaccinated with ChAdOx2 HAV, Groups 3 and 4 with MVA HAV and Group 5 with both vaccines in a prime-boost regimen. A

SUBMITTER: Sanderson J 

PROVIDER: S-EPMC11848756 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature