title: Safety and immunogenicity of two different lots of the oral, killed enterotoxigenic escherichia coli-cholera toxin B subunit vaccine in Israeli young adults.
abstract: Enterotoxigenic Escherichia coli (ETEC) is one of the leading causes of diarrhea among Israeli soldiers serving in field units. Two double-blind placebo-controlled, randomized trials were performed among 155 healthy volunteers to evaluate the safety and immunogenicity of different lots of the oral, killed ETEC vaccine consisting of two doses of whole cells plus recombinantly produced cholera toxin B subunit (rCTB). The two doses of vaccine lot E005 and the first dose of vaccine lot E003 were well tolerated by the volunteers. However, 5 (17%) vaccinees reported an episode of vomiting a few hours after the second dose of lot E003; none of the placebo recipients reported similar symptoms. Both lots of vaccine stimulated a rate of significant antibody-secreting cell (ASC) response to CTB and to colonization factor antigen I (CFA/I) after one or two doses, ranging from 85 to 100% and from 81 to 100%, respectively. The rate of ASC response to CS2, CS4, and CS5 was slightly lower than the rate of ASC response induced to CTB, CFA/I, and CS1. The second vaccine dose enhanced the response to CTB but did not increase the frequencies or magnitude of ASC responses to the other antigens. The two lots of the ETEC vaccine induced similar rates of serum antibody responses to CTB and CFA/I which were less frequent than the ASC responses to the same antigens. Based on these safety and immunogenicity data, an efficacy study of the ETEC vaccine is under way in the Israel Defense Force.
authors.affiliation: Army Health Branch Research Unit, Medical Corps, Israel Defence Force, Israel. danic@netvision.net.il
authors.forename: D
authors.initials: D
authors.lastname: Cohen
authors.forename: N
authors.initials: N
authors.lastname: Orr
authors.forename: M
authors.initials: M
authors.lastname: Haim
authors.forename: S
authors.initials: S
authors.lastname: Ashkenazi
authors.forename: G
authors.initials: G
authors.lastname: Robin
authors.forename: M S
authors.initials: MS
authors.lastname: Green
authors.forename: M
authors.initials: M
authors.lastname: Ephros
authors.forename: T
authors.initials: T
authors.lastname: Sela
authors.forename: R
authors.initials: R
authors.lastname: Slepon
authors.forename: I
authors.initials: I
authors.lastname: Ashkenazi
authors.forename: D N
authors.initials: DN
authors.lastname: Taylor
authors.forename: A M
authors.initials: AM
authors.lastname: Svennerholm
authors.forename: A
authors.initials: A
authors.lastname: Eldad
authors.forename: J
authors.initials: J
authors.lastname: Shemer
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D001426:Bacterial Proteins / Q000276:immunology / Q000627:therapeutic use*; D001428:Bacterial Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D002772:Cholera Toxin / Q000276:immunology; D003967:Diarrhea / Q000517:prevention & control*; D004311:Double-Blind Method; D004927:Escherichia coli Infections / Q000517:prevention & control*; D022361:Escherichia coli Vaccines; D005260:Female; D036781:Fimbriae Proteins; D006801:Humans; D007557:Israel; D008297:Male; D008889:Military Personnel; D010919:Placebos
chemical_list: D000907:Antibodies, Bacterial; D001426:Bacterial Proteins; D001428:Bacterial Vaccines; D022361:Escherichia coli Vaccines; D010919:Placebos; C022924:colonization factor antigens; D036781:Fimbriae Proteins; D002772:Cholera Toxin