Evaluation of safety and immunogenicity of recombinant influenza hemagglutinin (H5/Indonesia/05/2005) formulated with and without a stable oil-in-water emulsion containing glucopyranosyl-lipid A (SE+GLA) adjuvant

• Published in: Vaccine Vol. 31; no. 48; pp. 5760 - 5765
• Main Authors: Treanor, John J., Essink, Brandon, Hull, Steven, Reed, Steven, Izikson, Ruvim, Patriarca, Peter, Goldenthal, Karen L., Kohberger, Robert, Dunkle, Lisa M.
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 19.11.2013; Elsevier; Elsevier Limited
• Subjects: Adjuvants; Adjuvants, Immunologic - administration & dosage; Adjuvants, Immunologic - adverse effects; Adolescent; Adult; adults; Allergy and Immunology; Animals; Antibodies, Viral - blood; Antigens; Applied microbiology; Avian flu; Baculovirus; Biological and medical sciences; blood serum; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - pathology; Emergency medical care; Emulsions; Emulsions - administration & dosage; Emulsions - adverse effects; Female; Fundamental and applied biological sciences. Psychology; H5N1; Healthy Volunteers; hemagglutination; Hemagglutination Inhibition Tests; Hemagglutinin Glycoproteins, Influenza Virus - genetics; Hemagglutinin Glycoproteins, Influenza Virus - immunology; hemagglutinins; Hospitalization; Humans; Hydration; Immunization; Immunogenicity; influenza; Influenza Vaccines - administration & dosage; Influenza Vaccines - adverse effects; Influenza Vaccines - immunology; injection site; Insects; Licenses; lipid A; Lipid A - administration & dosage; Lipid A - adverse effects; Lipid A - analogs & derivatives; Lipids; Male; Microbiology; Middle Aged; Miscellaneous; Mortality; Mutation; Pain; pandemic; Pandemic influenza; Pandemics; Placebos - administration & dosage; Proteins; recombinant DNA; Recombinant Proteins - genetics; Recombinant Proteins - immunology; Studies; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Synthetic - administration & dosage; Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - immunology; Virology; Viruses; Young Adult; Asia; South east Asia; Indonesia; H5N1; Adjuvants; Vaccines; Pandemic influenza; Hemagglutinin; Tropical zone; Orthomyxoviridae; Zoopathogen; Vaccine; Infection; Virus; Influenzavirus A; Immunogenicity; Avian influenzavirus; Viral disease; Immunological adjuvant; Influenza

•We evaluated baculovirus-expressed recombinant H5 hemagglutinin vaccine with the adjuvant GLE/SE.•Adjuvanted vaccine was substantially more immunogenic at all dose levels than the unadjuvanted vaccine.•Even at the lowest dose of vaccine administered, serum HAI antibody responses of ≥1:40 were seen...