NCT00435526

Efficacy of Anti-CFA/I and CfaE Bovine Milk Immunoglobulin Against Challenge With H10407 ETEC Expressing CFA/I

Protective Efficacy of Orally Delivered Bovine Milk Immunoglobulin (BIgG) Specific for the Minor CFA/I Fimbrial Adhesin CfaE Against Challenge With H10407 Enterotoxigenic E. Coli (ETEC) Strain Expressing CFA/I

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess anti-CFA/I and anti-CfaE BIgG safety and to determine protective efficacy of anti-CFA/I and anti-CfaE BIgG against diarrhea after challenge with H10407, a CFA/I-expressing ETEC strain.

Detailed description

This is a Randomized, double-blinded, placebo-controlled trial involving up to 33 subjects. Subjects will be randomized into one of the following three groups. Group N Product 1. 10 BIgG anti-CFA/I 2. 10 BIgG anti-CfaE 3. 10 LactoFree® Lipil® Volunteers will receive the test article three times daily following meals beginning 2 days prior to oral ETEC challenge (strain H10407). Test article will be administered for a total of 7 days. Monitoring procedures will assess volunteer safety, the primary endpoint (diarrhea), stool microbiology (H10407 excretion), and ETEC-specific immunology. All volunteers will receive antibiotic treatment (ciprofloxacin, trimethoprim-sulfamethoxazole or amoxicillin) starting 5 days after ETEC challenge or sooner based on pre-defined clinical criteria. Follow-up visits for 2 weeks post-discharge will monitor safety and immunological parameters.

Conditions

• Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	anti-CFA/I bovine IgG, and anti-CfaE bovine IgG

Timeline

• Start date: 2006-03-01
• Completion: 2006-10-01
• First posted: 2007-02-15
• Last updated: 2007-02-15

Locations

2 sites across 1 country: United States