Safety and immunogenicity of a plant-produced recombinant hemagglutinin-based influenza vaccine (HAI-05) derived from A/Indonesia/05/2005 (H5N1) influenza virus: a phase 1 randomized, double-blind, placebo-controlled, dose-escalation study in healthy adults
| Autor: | Jessica A. Chichester, Fudu Miao, Mark Stow, Stephen J. Streatfield, Brian J. Green, R. Mark Jones, Vidadi Yusibov, George Moonsammy |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Male Adolescent Influenza vaccine plant-produced vaccine lcsh:QR1-502 Hemagglutinin (influenza) Hemagglutinin Glycoproteins Influenza Virus medicine.disease_cause Antibodies Viral lcsh:Microbiology Virus Article Young Adult recombinant vaccine Virology Influenza Human Tobacco Medicine Humans influenza A H5N1 hemagglutinin Adverse effect Reactogenicity biology Influenza A Virus H5N1 Subtype business.industry Immunogenicity Antibody titer Middle Aged Influenza A virus subtype H5N1 Recombinant Proteins Infectious Diseases Influenza Vaccines Immunology biology.protein business |
| Zdroj: | Viruses Viruses; Volume 4; Issue 11; Pages: 3227-3244 Viruses, Vol 4, Iss 11, Pp 3227-3244 (2012) |
| ISSN: | 1999-4915 |
| Popis: | Recently, we have reported [1,2] on a subunit influenza vaccine candidate based on the recombinant hemagglutinin protein from the A/Indonesia/05/2005 (H5N1) strain of influenza virus, produced it using 'launch vector'-based transient expression technology in Nicotiana benthamiana, and demonstrated its immunogenicity in pre-clinical studies. Here, we present the results of a first-in-human, Phase 1 randomized, double-blind, placebo-controlled study designed to investigate safety, reactogenicity and immunogenicity of three escalating dose levels of this vaccine, HAI-05, (15, 45 and 90 µg) adjuvanted with Alhydrogel® (0.75 mg aluminum per dose) and the 90 µg dose level without Alhydrogel®. Vaccine was administered intramuscularly in two injections three weeks apart to healthy adults of 18-49 years of age. At all dose levels the vaccine was generally safe and well tolerated, with no reported serious adverse events or dose-limiting toxicities. Mild local and systemic reactions were observed in all vaccine dose groups and the placebo group and their occurrence was not dose related. The incidence rates were higher in the groups receiving vaccine with Alhydrogel®. The immune response elicited by the HAI-05 vaccine was variable with respect to both hemagglutination-inhibition and virus microneutralization antibody titers, with the highest responses observed in the 90 µg unadjuvanted group. |
| Databáze: | OpenAIRE |
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