title: Intranasal administration of a proteosome-influenza vaccine is well-tolerated and induces serum and nasal secretion influenza antibodies in healthy human subjects.
abstract: Two randomized, blinded, active comparator-controlled trials of a prototype monovalent A/Beijing/262/95 (H1N1) - proteosome vaccine delivered by intranasal spray were performed in healthy adults. Overall, the intranasal proteosome-adjuvanted vaccine was well-tolerated with only mild stuffy nose and rhinorrhea seen more frequently in recipients of vaccine than in recipients of intranasal saline, and there were no serious adverse events. The intranasal proteosome-adjuvanted vaccine induced serum hemagglutination inhibiting (HAI) and nasal secretory IgA (sIgA) responses specific for the influenza antigen. Serum HAI responses were most influenced by the dosage level, whereas mucosal sIgA responses, although demonstrable with both single-dose and two-dose vaccine regimens, appeared to be greater in response to two-dose regimens (regardless of dose level). Further evaluation of mucosal influenza immunization using the proteosome adjuvant/delivery system is clearly warranted.
authors.affiliation: Infectious Diseases Unit, University of Rochester School of Medicine, 601 Elmwood Avenue, Room 3-6308, Rochester, NY 14642-0001, USA. John.Treanor@urmc.rochester.edu
authors.forename: John
authors.initials: J
authors.lastname: Treanor
authors.forename: Carrie
authors.initials: C
authors.lastname: Nolan
authors.forename: Diane
authors.initials: D
authors.lastname: O'Brien
authors.forename: David
authors.initials: D
authors.lastname: Burt
authors.forename: George
authors.initials: G
authors.lastname: Lowell
authors.forename: Janine
authors.initials: J
authors.lastname: Linden
authors.forename: Louis
authors.initials: L
authors.lastname: Fries
mesh_terms: D000276:Adjuvants, Immunologic; D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis*; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D018928:Immunity, Mucosal / Q000276:immunology*; D007070:Immunoglobulin A / Q000032:analysis / Q000096:biosynthesis; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D009297:Nasal Mucosa / Q000276:immunology; D009345:Neisseria meningitidis / Q000276:immunology; D046988:Proteasome Endopeptidase Complex / Q000276:immunology*; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007070:Immunoglobulin A; D007252:Influenza Vaccines; D014614:Vaccines, Synthetic; D046988:Proteasome Endopeptidase Complex