Development of VAX128, a recombinant hemagglutinin (HA) influenza-flagellin fusion vaccine with improved safety and immune response

• Published in: Vaccine 2012-08, Vol.30 (39), p.5761-5769
• Main Authors: Taylor, David N, Treanor, John J, Sheldon, Eric A, Johnson, Casey, Umlauf, Scott, Song, Langzhou, Kavita, Uma, Liu, Ge, Tussey, Lynda, Ozer, Karen, Hofstaetter, Thomas, Shaw, Alan
• Format: Article
• Language: English
• Subjects: Adjuvants, Immunologic - administration & dosage; Adolescent; Adult; adults; Aged; Allergy and Immunology; Animals; Antibodies, Viral - blood; blood serum; Body temperature; C-reactive protein; C-Reactive Protein - immunology; C-Terminus; Clinical trials; Cytokines; Double-Blind Method; Female; Flagellin; Flagellin - immunology; Flagellin adjuvant; Frailty; Hemagglutination Inhibition Tests; Hemagglutinin Glycoproteins, Influenza Virus - immunology; Hemagglutinins; Humans; Immune response; Immunogenicity; Influenza; Influenza prevention; Influenza vaccine; Influenza Vaccines - administration & dosage; Influenza Vaccines - adverse effects; Influenza Vaccines - immunology; Influenza, Human - prevention & control; Interleukin 6; Interleukin-6 - immunology; Laboratories; Male; Middle Aged; Rabbits; Recombinant vaccine; Seroconversion; Studies; temperature; Temperature effects; TLR5 protein; Toll-like receptors; Vaccine; Vaccines; Vaccines, Synthetic - administration & dosage; Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - immunology; Young Adult
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2012.06.086

Highlights ► Recombinant influenza vaccines differ in safety profiles according to configuration. ► VAX128C was well tolerated up to a dose of 20 μg. ► Dose of 1.25 or 2.5 μg of VAX128C gave peak GMT was 385, 79% SC and 92% SP.