title: Oral, inactivated, whole cell enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine: results of the initial evaluation in children. PRIDE Study Group.
abstract: Two randomized, double-blinded trials assessed the safety and immunogenicity of an oral, killed enterotoxigenic Escherichia coli (ETEC) plus cholera toxin B subunit vaccine in Egyptian children. Two doses of vaccine or E. coli K-12 were given 2 weeks apart to 105 6- to 12-year-olds and 97 2- to 5-year-olds. Safety was monitored for 3 days after each dose. Blood was collected before immunization and 7 days after each dose to measure immune responses. Few children reported postdosing symptoms, with no differences in the frequency of symptoms between treatment groups. Most vaccinees had an IgA antibody-secreting cell response against colonization factor antigen I (100%, 6-12 years; 95%, 2-5 years), coli surface antigen 2 (92%, 6-12 years; 83%, 2-5 years), and coli surface antigen 4 (93%, 6-12 years). Vaccination evoked a >/=4-fold rise in antitoxic IgA and IgG titers in 93% and 81% of children, respectively. In conclusion, the oral ETEC vaccine was safe and immunogenic in 2- to 12-year-old children, justifying further evaluation in infants.
authors.affiliation: US Naval Medical Research Unit Number 3, Bethesda, MD, USA. savarino@namru3.navy.mil
authors.forename: S J
authors.initials: SJ
authors.lastname: Savarino
authors.forename: E R
authors.initials: ER
authors.lastname: Hall
authors.forename: S
authors.initials: S
authors.lastname: Bassily
authors.forename: F M
authors.initials: FM
authors.lastname: Brown
authors.forename: F
authors.initials: F
authors.lastname: Youssef
authors.forename: T F
authors.initials: TF
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: H
authors.initials: H
authors.lastname: El Mohamady
authors.forename: R
authors.initials: R
authors.lastname: Abu-Elyazeed
authors.forename: A
authors.initials: A
authors.lastname: Naficy
authors.forename: A M
authors.initials: AM
authors.lastname: Svennerholm
authors.forename: M
authors.initials: M
authors.lastname: Jertborn
authors.forename: Y J
authors.initials: YJ
authors.lastname: Lee
authors.forename: J D
authors.initials: JD
authors.lastname: Clemens
mesh_terms: D000284:Administration, Oral; D000367:Age Factors; D000907:Antibodies, Bacterial / Q000097:blood; D001428:Bacterial Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D002772:Cholera Toxin / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D015331:Cohort Studies; D004311:Double-Blind Method; D004534:Egypt; D004926:Escherichia coli / Q000276:immunology*; D004927:Escherichia coli Infections / Q000517:prevention & control; D022361:Escherichia coli Vaccines; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D012449:Safety; D013997:Time Factors; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D001428:Bacterial Vaccines; D022361:Escherichia coli Vaccines; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D018074:Vaccines, Conjugate; D015164:Vaccines, Inactivated; D002772:Cholera Toxin