Cross-protection by B subunit-whole cell cholera vaccine against diarrhea associated with heat-labile toxin-producing enterotoxigenic Escherichia coli: results of a large-scale field trial.
The B subunit (BS) of cholera toxin and that of the heat-labile enterotoxin (LT) of enterotoxigenic Escherichia coli (ETEC) are antigenically similar. We therefore assessed whether a combined cholera toxin BS/whole-cell (BS-WC) oral vaccine against cholera conferred cross-protection against LT-producing ETEC (LT-ETEC) diarrhea in a randomized, double-blind field trial among rural Bangladeshi children and women. The 24,770 persons who ingested two or more doses of BS-WC vaccine were compared with 24,842 controls who took two or more doses of killed whole-cell (WC) oral cholera vaccine. Sixty-seven percent fewer episodes of LT-ETEC diarrhea were noted in the BS-WC group than in the WC group during short-term (three-month) follow-up (P less than .01), but no reduction was evident during the ensuing nine months. Short-term protection was particularly notable against LT-ETEC diarrhea causing life-threatening dehydration (protective efficacy, 86%; P less than .05).
D000293:Adolescent; D001427:Bacterial Toxins / Q000378:metabolism; D002648:Child; D002675:Child, Preschool; D002772:Cholera Toxin / Q000276:immunology*; D022121:Cholera Vaccines / Q000276:immunology*; D002986:Clinical Trials as Topic; D003429:Cross Reactions; D003967:Diarrhea / Q000382:microbiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004768:Enterotoxins / Q000378:metabolism; D004926:Escherichia coli / Q000378:metabolism; D004927:Escherichia coli Infections / Q000382:microbiology / Q000517:prevention & control*; D029968:Escherichia coli Proteins; D005260:Female; D006801:Humans; D007109:Immunity; D010446:Peptide Fragments / Q000276:immunology*; D011897:Random Allocation; D014611:Vaccination
D001427:Bacterial Toxins; D022121:Cholera Vaccines; D004768:Enterotoxins; D029968:Escherichia coli Proteins; D010446:Peptide Fragments; C050310:cholera toxin, B subunit (50-64); D002772:Cholera Toxin; C027538:heat-labile enterotoxin, E coli