title: Safety and immunogenicity of intranasally administered inactivated trivalent virosome-formulated influenza vaccine containing Escherichia coli heat-labile toxin as a mucosal adjuvant.
abstract: A trivalent influenza virosome vaccine containing hemagglutinin and Escherichia coli heat-labile toxin (HLT) was administered intranasally to young adults and elderly subjects. Symptoms that followed immunization were mild and transient. A significant increase in serum hemagglutination inhibition (HI) antibody was noted for the 3 vaccine strains. There was no significant difference in postimmunization geometric mean titers or seroconversion rates between age groups. The percentage of subjects attaining protective HI titers (>/=40%) was comparable in both groups for the A/Bayern (P=.5) and B/Beijing (P=.3) strains but was higher among young adults (92.2%) versus elderly subjects (76.5%; P=.057) for the A/Wuhan strain. The proportion of subjects with nonprotective baseline titers who attained protective levels after immunization was similar in both age groups for the A/Bayern and B/Beijing components. For the A/Wuhan component, significantly (P=.017) more young adults achieved protective titers versus elderly subjects (85. 7% and 53.8%, respectively). Vaccination evoked a significant (P<. 005) increase in anti-HLT antibody titers.
authors.affiliation: BERNA, Swiss Serum and Vaccine Institute Berne, Bern, Switzerland.
authors.forename: R
authors.initials: R
authors.lastname: Glück
authors.forename: R
authors.initials: R
authors.lastname: Mischler
authors.forename: P
authors.initials: P
authors.lastname: Durrer
authors.forename: E
authors.initials: E
authors.lastname: Fürer
authors.forename: A B
authors.initials: AB
authors.lastname: Lang
authors.forename: C
authors.initials: C
authors.lastname: Herzog
authors.forename: S J
authors.initials: SJ
authors.lastname: Cryz
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D001427:Bacterial Toxins / Q000008:administration & dosage* / Q000276:immunology; D004768:Enterotoxins / Q000008:administration & dosage* / Q000276:immunology; D004926:Escherichia coli / Q000472:pathogenicity*; D029968:Escherichia coli Proteins; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D008875:Middle Aged
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D001427:Bacterial Toxins; D004768:Enterotoxins; D029968:Escherichia coli Proteins; D007252:Influenza Vaccines; C027538:heat-labile enterotoxin, E coli