Dose-related safety and immunogenicity of a trivalent baculovirus-expressed influenza-virus hemagglutinin vaccine in elderly adults.

Publication Type
Journal Article
Year of Publication
Treanor, John J; Schiff, Gilbert M; Couch, Robert B; Cate, Thomas R; Brady, Rebecca C; Hay, C Mhorag; Wolff, Mark; She, Dewei; Cox, Manon M J
J Infect Dis
Date Published
2006 May 01
Adult; Aged; Aged, 80 and over; Antibodies, Viral; Baculoviridae; Dose-Response Relationship, Immunologic; Female; Hemagglutinin Glycoproteins, Influenza Virus; Humans; Influenza Vaccines; Male; Maximum Tolerated Dose; Middle Aged; Vaccines, Inactivated

BACKGROUND: Influenza-virus hemagglutinin (HA) protein expressed in insect cells by recombinant baculovirus is a candidate influenza vaccine.

METHODS: In a randomized, double-blind trial conducted in 399 adults > or = 65 years of age, the efficacy of trivalent inactivated influenza vaccine (TIV) licensed for intramuscular injection was compared with that of trivalent baculovirus-expressed HA vaccine administered at doses of 15 microg, 45 microg, or 135 microg of each HA.

RESULTS: Compared with TIV, baculovirus-expressed HA vaccine was safe and induced better serum antibody responses to the H3 component when administered at doses of 45 microg or 135 microg of each HA.

CONCLUSIONS: Baculovirus-expressed HA is a safe and immunogenic influenza vaccine in elderly adults.