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:
-
Safe application
- Infectious period risk mitigated by close monitoring and prospectively applied early treatment criteria
- Potential post-infectious sequelae risk mitigated by appropriate strain and host selection
- 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.
Detailed Summary:
Sponsor: University of Vermont
Current Primary Outcome: Establish a safe challenge model of Campylobacter jejuni [ Time Frame: October 2008 ]
Original Primary Outcome:
Current Secondary Outcome: Measurement of the human immune response to Campylobacter jejuni infection [ Time Frame: October 2008 ]
Original Secondary Outcome:
Information By: University of Vermont
Dates:
Date Received: February 6, 2007
Date Started: February 2007
Date Completion: October 2008
Last Updated: June 4, 2008
Last Verified: June 2008