title: Randomized double-blind placebo controlled trial to evaluate the safety and immunogenicity of the live oral cholera vaccine strain CVD 103-HgR in Swiss adults.
abstract: A randomized, double-blind, placebo controlled trial was conducted in 50 healthy Swiss adults to assess the safety and immunogenicity of the live oral attenuated cholera vaccine candidate strain Vibrio cholerae CVD 103-HgR (classical, Inaba). A single dose of 5 x 10(8) viable CVD 103-HgR organisms, administered in a buffered liquid formulation, was well tolerated as compared with individuals who received an equivalent amount of heat-killed Escherichia coli K-12 placebo. Eighty-eight percent of subjects receiving CVD 103-HgR mounted a significant (greater than fourfold) rise in Inaba vibriocidal titre while 68% did so for the heterologous Ogawa serotype. The magnitude of the vibriocidal antibody response (as measured by peak geometric mean titre and by fold-rise in titre over baseline) was greater for the homologous Inaba serotype. Nineteen out of 25 volunteers (76%) responded with a significant (p less than 0.05) rise in serum antitoxin levels. No vaccinee who received the E. coli K-12 placebo mounted a significant rise in either vibriocidal or antitoxin antibody levels. These results corrobrate the safety and immunogenicity of CVD 103-HgR in healthy adult volunteers.
authors.affiliation: Swiss Serum and Vaccine Institute, Berne.
authors.forename: S J
authors.initials: SJ
authors.lastname: Cryz
authors.forename: M M
authors.initials: MM
authors.lastname: Levine
authors.forename: J B
authors.initials: JB
authors.lastname: Kaper
authors.forename: E
authors.initials: E
authors.lastname: Fürer
authors.forename: B
authors.initials: B
authors.lastname: Althaus
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000917:Antibody Formation / Q000276:immunology; D000992:Antitoxins / Q000276:immunology; D002772:Cholera Toxin / Q000276:immunology / Q000592:standards; D022121:Cholera Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000494:pharmacology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007114:Immunization / Q000009:adverse effects; D007074:Immunoglobulin G / Q000276:immunology / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D010919:Placebos; D014734:Vibrio cholerae / Q000276:immunology
chemical_list: D000992:Antitoxins; D022121:Cholera Vaccines; D007074:Immunoglobulin G; D010919:Placebos; D002772:Cholera Toxin