Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434798
Status:
UNKNOWN
Last Update Posted:
2008-06-05
First Post:
2007-02-06
Brief Title:
Campylobacter Jejuni Challenge Model Development Dose Ranging Study
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
Campylobacter Jejuni Challenge Model Development Dose Ranging Study
Status:
UNKNOWN
Status Verified Date:
2008-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None