Clinical Trial: Campylobacter Jejuni Challenge Model Development: Dose Ranging Study

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional



Official Title: Campylobacter Jejuni Challenge Model Development: Dose Ranging Study

Brief Summary:

The primary objective of this study is to establish a human Campylobacter jejuni infection model with the following characteristics:

  1. Safe application

    1. Infectious period risk mitigated by close monitoring and prospectively applied early treatment criteria
    2. Potential post-infectious sequelae risk mitigated by appropriate strain and host selection
  2. Campylobacteriosis attack rate of at least 75%

Secondary objectives are to determine humoral, cell-mediated, and mucosal immune responses in the newly established human C. jejuni infection model and evaluate short-term (< 3 mo) protection upon repeat exposure to homologous C. jejuni strain and assess immune responses associated with protection.