title: Safety and immunogenicity of a live oral bivalent typhoid fever (Salmonella typhi Ty21a)-cholera (Vibrio cholerae CVD 103-HgR) vaccine in healthy adults.
abstract: The safety and immunogenicity of the live oral attenuated vaccine strains vibrio cholerae CVD 103-HgR and Salmonella typhi Ty21a were evaluated alone or in a combined bivalent formulation in four groups composed of 185 healthy European adults. All presentations were well tolerated. The serum anti-S. typhi lipopolysaccharide immunoglobulin G and immunoglobulin A antibody responses were comparable for all groups (66 to 72% seroconversion). The serum vibriocidal antibody seroconversion rate ranged from 78 to 92.5% (P > 0.05) among the groups. However, the peak and geometric mean vibriocidal antibody titers were significantly higher (P < 0.005) in the groups which received the bivalent formulation along with two doses of Ty21a than in the group which received CVD 103-HgR followed by two doses of killed Escherichia coli K-12 placebo. The ingestion of a placebo shortly after CVD 103-HgR may have suppressed the magnitude of the immune response. These findings demonstrate the feasibility of producing multivalent live oral attenuated vaccines.
authors.affiliation: Swiss Serum and Vaccine Institute, Berne.
authors.forename: S J
authors.initials: SJ
authors.lastname: Cryz
authors.forename: J U
authors.initials: JU
authors.lastname: Que
authors.forename: M M
authors.initials: MM
authors.lastname: Levine
authors.forename: G
authors.initials: G
authors.lastname: Wiedermann
authors.forename: H
authors.initials: H
authors.lastname: Kollaritsch
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000096:biosynthesis; D002771:Cholera / Q000517:prevention & control*; D022121:Cholera Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000592:standards; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000096:biosynthesis; D007074:Immunoglobulin G / Q000096:biosynthesis; D008297:Male; D008875:Middle Aged; D012485:Salmonella typhi / Q000276:immunology; D013997:Time Factors; D014435:Typhoid Fever / Q000517:prevention & control*; D014436:Typhoid-Paratyphoid Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000592:standards; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology* / Q000592:standards; D014734:Vibrio cholerae / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D014436:Typhoid-Paratyphoid Vaccines; D014613:Vaccines, Attenuated