title: Lack of prophylactic efficacy of an enteric-coated bovine hyperimmune milk product against enterotoxigenic Escherichia coli challenge administered during a standard meal.
abstract: Orally administered bovine immunoglobulins with specific activity against colonization factors of enterotoxigenic Escherichia coli (ETEC) could provide passive protection against ETEC challenge in volunteers. Twenty healthy adult volunteers ingested either a placebo or a partially enteric-coated preparation of bovine immunoglobulins with activity against the colonization factor antigens CFA/I, CS3, and CS6 and then were challenged with ETEC strain E24377A (CS1+, CS3+) administered with a standard meal. There was no difference in the incidence or severity of diarrhea among the 10 volunteers who received the bovine immunoglobulins and the 10 who received placebo. Either the specificity or titer of anti-colonization factor antibodies or the formulation of antibodies in this product was not adequate to provide passive protection against ETEC challenge.
authors.affiliation: Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD 21201, USA. ctacket@medicine.umaryland.edu
authors.forename: C O
authors.initials: CO
authors.lastname: Tacket
authors.forename: G
authors.initials: G
authors.lastname: Losonsky
authors.forename: S
authors.initials: S
authors.lastname: Livio
authors.forename: R
authors.initials: R
authors.lastname: Edelman
authors.forename: J
authors.initials: J
authors.lastname: Crabb
authors.forename: D
authors.initials: D
authors.lastname: Freedman
mesh_terms: D000328:Adult; D000818:Animals; D001426:Bacterial Proteins / Q000276:immunology* / Q000378:metabolism; D002214:Capsules; D002417:Cattle; D003967:Diarrhea / Q000382:microbiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004435:Eating; D004926:Escherichia coli / Q000276:immunology* / Q000378:metabolism; D004927:Escherichia coli Infections / Q000517:prevention & control*; D005243:Feces / Q000382:microbiology; D036781:Fimbriae Proteins; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage* / Q000276:immunology; D008892:Milk / Q000276:immunology
chemical_list: D001426:Bacterial Proteins; D002214:Capsules; D007136:Immunoglobulins; C022924:colonization factor antigens; D036781:Fimbriae Proteins