title: Safety and immunogenicity of an oral, killed enterotoxigenic Escherichia coli-cholera toxin B subunit vaccine in Egyptian adults.
abstract: Enterotoxigenic Escherichia coli (ETEC) is the leading cause of bacterial diarrhea in young children in developing countries. The safety and immunogenicity of a killed, oral ETEC vaccine consisting of whole cells plus recombinantly produced cholera toxin B subunit (rCTB) was evaluated in Egypt, which is endemic for ETEC diarrhea. Seventy-four healthy Egyptian adults (21-45 years old) were randomized and received two doses of the ETEC/rCTB vaccine (E003) or placebo 2 weeks apart. The frequency of adverse events after either dose did not differ by treatment group, and no severe adverse events were reported. After vaccination, peripheral blood IgA B cell responses to CTB (100%) and to vaccine colonization factor antigens CFA/I (94%), CS4 (100%), CS2 (81%), and CS1 (69%) were significantly higher than response rates for the placebo group. These favorable results in Egyptian adults indicate that the ETEC/rCTB vaccine is a promising candidate for evaluation in younger age groups in this setting.
authors.affiliation: US Naval Medical Research Unit No. 3, Cairo, Egypt. savarino@namru3.navy.mil
authors.forename: S J
authors.initials: SJ
authors.lastname: Savarino
authors.forename: F M
authors.initials: FM
authors.lastname: Brown
authors.forename: E
authors.initials: E
authors.lastname: Hall
authors.forename: S
authors.initials: S
authors.lastname: Bassily
authors.forename: F
authors.initials: F
authors.lastname: Youssef
authors.forename: T
authors.initials: T
authors.lastname: Wierzba
authors.forename: L
authors.initials: L
authors.lastname: Peruski
authors.forename: N A
authors.initials: NA
authors.lastname: El-Masry
authors.forename: M
authors.initials: M
authors.lastname: Safwat
authors.forename: M
authors.initials: M
authors.lastname: Rao
authors.forename: M
authors.initials: M
authors.lastname: Jertborn
authors.forename: A M
authors.initials: AM
authors.lastname: Svennerholm
authors.forename: Y J
authors.initials: YJ
authors.lastname: Lee
authors.forename: J D
authors.initials: JD
authors.lastname: Clemens
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood*; D001428:Bacterial Vaccines / Q000276:immunology*; D004534:Egypt; D004926:Escherichia coli / Q000276:immunology*; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D008297:Male; D008875:Middle Aged; D014614:Vaccines, Synthetic / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D001428:Bacterial Vaccines; D007070:Immunoglobulin A; D014614:Vaccines, Synthetic