Campylobacter Jejuni Challenge Model Development: Dose Ranging Study

NCT00434798 | Unknown Phase 1

• 1 other identifier: NMRC.2006.0009
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to establish a human Campylobacter jejuni infection model with the following characteristics:

1. 1.Safe application
2. 2.Infectious period risk mitigated by close monitoring and prospectively applied early treatment criteria
3. 3.Potential post-infectious sequelae risk mitigated by appropriate strain and host selection
4. 4.Campylobacteriosis attack rate of at least 75%

Conditions

Campylobacter Infections

Keywords

Campylobacter infections

Outcome Measures

Primary Outcomes (1)

• Establish a safe challenge model of Campylobacter jejuni

  October 2008

Secondary Outcomes (1)

• Measurement of the human immune response to Campylobacter jejuni infection

  October 2008

Interventions

Campylobacter jejuni strains CG8421 and BH-01-0142 BIOLOGICAL

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 Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vermont: lead
• Naval Medical Research Center: collaborator
• TD Vaccines A/S: collaborator

Study Sites (1)

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Campylobacter Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2007
• First Posted: February 13, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: June 5, 2008

Record last verified: 2008-06

Locations

US (1)