title: Recombinant baculovirus influenza A hemagglutinin vaccines are well tolerated and immunogenic in healthy adults.
abstract: In a prospective double-blind trial, the reactogenicity and immunogenicity of recombinant baculovirus influenza A vaccines containing purified full-length hemagglutinin (HA) were compared with standard trivalent inactivated vaccine (TIV). The recombinant baculovirus influenza A vaccines (rHA0) were monovalent (containing 45 micrograms of A/Beijing/92[H3] and 15, 45, and 135 micrograms of A/Texas/91[H1]) and bivalent (containing 45 micrograms of both A/Beijing/92 and A/Texas/91). The bivalent rHA0 vaccine produced fewer local side effects than the TIV (50% vs. 88%, P = .003). The hemagglutinin inhibition (HAI) responses (defined as a > or = 4 increase in HAI) to A/Beijing rHA0 in the monovalent A/Beijing/92, the bivalent vaccine, and the TIV were 68%, 76%, and 46%, respectively (P = .086). Increasing doses of A/Texas rHA0 (15 micrograms [60%], 45 micrograms [69%], and 135 micrograms [76%]) and bivalent HA (76%) gave better immunologic responses to H1 than did TIV (31%; P = .003).
authors.affiliation: Department of Pediatrics, Vanderbilt University, Nashville, Tennessee 37232-2581, USA.
authors.forename: D L
authors.initials: DL
authors.lastname: Lakey
authors.forename: J J
authors.initials: JJ
authors.lastname: Treanor
authors.forename: R F
authors.initials: RF
authors.lastname: Betts
authors.forename: G E
authors.initials: GE
authors.lastname: Smith
authors.forename: J
authors.initials: J
authors.lastname: Thompson
authors.forename: E
authors.initials: E
authors.lastname: Sannella
authors.forename: G
authors.initials: G
authors.lastname: Reed
authors.forename: B E
authors.initials: BE
authors.lastname: Wilkinson
authors.forename: P F
authors.initials: PF
authors.lastname: Wright
mesh_terms: D000293:Adolescent; D000328:Adult; D016367:Baculoviridae / Q000235:genetics; D004311:Double-Blind Method; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000276:immunology*; D006801:Humans; D007252:Influenza Vaccines / Q000276:immunology*; D008875:Middle Aged; D011446:Prospective Studies; D015164:Vaccines, Inactivated / Q000276:immunology; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology*
chemical_list: D019267:Hemagglutinin Glycoproteins, Influenza Virus; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated; D014614:Vaccines, Synthetic