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Campylobacter Jejuni Challenge Model Development: Dose Ranging Study
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University of Vermont
Naval Medical Research Center
ACE BioSciences A/S
Information provided by: University of Vermont
ClinicalTrials.gov Identifier: NCT00434798
  Purpose

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.


Condition Intervention Phase
Campylobacter Infections
Biological: Campylobacter jejuni strains CG8421 and BH-01-0142
Phase I

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment
Official Title: Campylobacter Jejuni Challenge Model Development: Dose Ranging Study

Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Establish a safe challenge model of Campylobacter jejuni [ Time Frame: October 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of the human immune response to Campylobacter jejuni infection [ Time Frame: October 2008 ] [ Designated as safety issue: No ]

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)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female between 18 and 50 years of age, inclusive.
  • General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by principal investigator or principal investigator in consultation with the medical monitor and sponsor.
  • Demonstrate comprehension of the protocol procedures and knowledge of Campylobacter illness by passing a written examination (pass grade ≥ 70%)
  • Willing to participate after informed consent obtained.
  • Available for all planned follow-up visits.
  • Negative urine pregnancy test at screening and a negative urine pregnancy test on the day of admittance to the inpatient phase for all female subjects.

Exclusion Criteria:

  • Presence of a significant medical condition, (e.g. psychiatric conditions or gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis, inflammatory bowel disease, irritable bowel syndrome, alcohol or illicit drug abuse/dependency), or other laboratory abnormalities which in the opinion of the investigator precludes participation in the study.
  • Immunosuppressive illness, IgA deficiency (below the normal limits), or antihistamine use within 48 h of admission or during inpatient period.
  • Positive serology results for HIV, HBsAg, or HCV antibodies.
  • Significant abnormalities in screening lab hematology, serum chemistry, as determined by PI or PI in consultation with the medical monitor and sponsor.
  • Use of any medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding receipt of the challenge inoculum or planned use during the active study period.
  • Are not capable of fully informed consent (e.g. cannot read or write English)
  • Personal or documented family history of an inflammatory arthritis such as reactive arthritis, Reiter's syndrome, ankylosing spondylitis, rheumatoid arthritis, or Guillain-Barré syndrome (would not include osteoarthritis or vague history of arthritis relatively late in adulthood).
  • Evidence of neurologic abnormalities (specifically extremity weakness, abnormal deep tendon reflexes, symmetric sensory abnormalities - vibratory, light touch, and proprioception).
  • Evidence of inflammatory arthritis on exam and/or HLA-B27 positive.
  • Allergy or prior intolerance to either azithromycin or fluoroquinolones.
  • Fewer than 3 stools per week or more than 3 stools per day as the usual frequency, loose or liquid stools other than on an occasional basis.
  • Regular use of laxatives or any agent that increase gastric pH (regular defined as at least weekly).
  • A recent fever in the 2 weeks prior to time of challenge.
  • Use of antibiotics during the 7 days before bacterial dosing or proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing.
  • Use of any investigational product within 30 days preceding the receipt of the challenge inoculum, or planned use during the active study period.
  • History of diarrhea in the 2 weeks prior to planned inpatient phase
  • Stool culture (collected no more than 1 week prior to admission) positive for Campylobacter, other bacterial enteric pathogens (Salmonella, Shigella, or enterohemorrhagic E. coli), or intestinal parasites.
  • Have household contacts who are <2 years old or >80 years old or infirmed or immunocompromised (for reasons including corticosteroid therapy, HIV infection, cancer chemotherapy, or other chronic debilitating disease).
  • Work as either a health care personnel with direct patient care, daycare center (for children or the elderly) personnel, or food handlers. Food handlers include individuals who work in restaurants, cafeterias, and retail stores/supermarkets that feature produce, salad bars, and/or deli sections.
  • History of microbiologically confirmed Campylobacter infection
  • Immunologic evidence of Campylobacter exposure:

    • serologic evidence of prior Campylobacter infection [defined as homologous strain Campylobacter-specific anti-glycine extract (GE) IgA OD650 > 0.5 at > 1:1,000 dilution]
    • cell mediated immune response evidence of prior Campylobacter infection [in vitro stimulation of PBMC with WC antigen (formalin-fixed homologous strain Campylobacter whole cells) with supernatant IFN-Gamma ≥ 500pg/ml]
  • Travel to countries with high Campylobacter rates (to include Asia, Africa, and Central and South America) within two years prior to dosing.
  • History of vaccination for or ingestion of Campylobacter.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434798

Locations
United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
Naval Medical Research Center
ACE BioSciences A/S
  More Information

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

Keywords provided by University of Vermont:
Campylobacter infections

Study placed in the following topic categories:
Bacterial Infections
Campylobacter Infections
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on January 13, 2009