Campylobacter Infections Clinical Trial
Official title:
Campylobacter Jejuni Challenge Model Development: Dose Ranging Study
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.
n/a
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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