title: Safety and immunogenicity in North Americans of a single dose of live oral cholera vaccine CVD 103-HgR: results of a randomized, placebo-controlled, double-blind crossover trial.
abstract: We conducted a double-blind, placebo-controlled, randomized crossover study to evaluate the safety and immunogenicity of a single 5 x 10(8)-CFU dose of live oral recombinant cholera vaccine CVD 103-HgR in 94 North American adults. The vaccine was well tolerated without associated adverse reactions. Despite minimal fecal excretion of vaccine, 97% of subjects exhibited serum vibriocidal antibody and 72% had antitoxin responses.
authors.affiliation: Department of Pediatrics, University of Maryland School of Medicine, Baltimore 21201.
authors.forename: K L
authors.initials: KL
authors.lastname: Kotloff
authors.forename: S S
authors.initials: SS
authors.lastname: Wasserman
authors.forename: S
authors.initials: S
authors.lastname: O'Donnell
authors.forename: G A
authors.initials: GA
authors.lastname: Losonsky
authors.forename: S J
authors.initials: SJ
authors.lastname: Cryz
authors.forename: M M
authors.initials: MM
authors.lastname: Levine
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000032:analysis; D022121:Cholera Vaccines / Q000009:adverse effects / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D012449:Safety; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; D014614:Vaccines, Synthetic