Recombinant Baculovirus Influenza A Hemagglutinin Vaccines Are Well Tolerated and Immunogenic in Healthy Adults.

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 (TIY). The recombinant baculovirus influenza A vaccines (THAO)were monovalent (containing 45 µg of A/Beijing/92[H3] and 15,45, and 135 µg of A/Texas/ 91[H1)) and bivalent (containing 45 µg of both A/Beijing/92 and A/Texas/91). The bivalent rHAO vaccine produced fewer local side effects than the TIY (50% vs. 88%, P = .003). The hemagglutinin inhibition (HAl) responses (defined as a ⩾4 increase in HAl) to A/Beijing rHAO in the monovalent A/Beijing/92, the bivalent vaccine, and the TIY were 68%, 76%, and 46%, respectively (P = .086). Increasing doses of A/Texas rHAO (15 µg [60%], 45 µg [69%], and 135 µg [76%)) and bivalent HA (76%) gave better immunologic responses to H1 than did TIY (31%; P = .003). [ABSTRACT FROM PUBLISHER]