Efficacy of Anti-CFA/I and CfaE Bovine Milk Immunoglobulin Against Challenge With H10407 ETEC Expressing CFA/I (BIgGI)
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.
Biological: anti-CFA/I bovine IgG, and anti-CfaE bovine IgG
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
|Official Title:||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|
- Clinical diagnosis of diarrhea defined as 1 loose/liquid stool (≥ Grade 3) of >300 g OR ≥ 2 loose/liquid stools totaling ≥ 200 g during any 48-hour period within 120 hours of challenge with ETEC strain H10407.
- Prevention of moderate to severe diarrhea.
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||October 2006|
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
- 10 BIgG anti-CFA/I
- 10 BIgG anti-CfaE
- 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.
|United States, Maryland|
|Johns Hopkins Bayview Medicial Center, Inpatient Unit|
|Baltimore, Maryland, United States, 21224|
|General Clinical Research Center|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Robin McKenzie, M.D.||Johns Hopkins School of Public|