NCT00434798

Campylobacter Jejuni Challenge Model Development: Dose Ranging Study

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

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.

Conditions

• Campylobacter Infections

Interventions

Type	Name	Description
BIOLOGICAL	Campylobacter jejuni strains CG8421 and BH-01-0142	Campylobacter jejuni strains CG8421 and BH-01-0142 at a single dose. Dosing will be based on attack rate, to achieve a 75% attack rate. Anticipate use of 10\^6-10\^9 CFU

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-02-13
• Last updated: 2008-06-05

Locations

1 site across 1 country: United States