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Sponsors and Collaborators: |
University of Vermont Naval Medical Research Center ACE BioSciences A/S |
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Information provided by: | University of Vermont |
ClinicalTrials.gov Identifier: | NCT00434798 |
The primary objective of this study is to establish a human Campylobacter jejuni infection model with the following characteristics:
Safe application
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.
Condition | Intervention | Phase |
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Campylobacter Infections |
Biological: Campylobacter jejuni strains CG8421 and BH-01-0142 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment |
Official Title: | Campylobacter Jejuni Challenge Model Development: Dose Ranging Study |
Estimated Enrollment: | 50 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Immunologic evidence of Campylobacter exposure:
Responsible Party: | University of Vermont ( Beth Kirkpatrick, M.D., Principal Investigator ) |
Study ID Numbers: | NMRC.2006.0009 |
Study First Received: | February 6, 2007 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00434798 |
Health Authority: | United States: Food and Drug Administration |
Campylobacter infections |
Bacterial Infections Campylobacter Infections Gram-Negative Bacterial Infections |
Infection |