title: Immunogenic and protective properties of the first Kazakhstan vaccine against pandemic influenza A (H1N1) pdm09 in ferrets.
abstract: This paper presents the results of a pre-clinical study of the immunogenicity and efficacy of an egg-derived, inactivated, whole-virion adjuvanted vaccine (Refluvac®) on ferret models. For this purpose, groups of eight ferrets (6 to 7 months old) were injected with 0.5 mL of vaccine specimens containing 3.75, 7.5 or 15.0 μg of virus hemagglutinin. Administration was intramuscular and given either as a single dose or as two doses 14 days apart. All vaccine specimens manifested immunogenicity in ferrets for single (HI titer, from 51 ± 7 to 160 ± 23) and double (HI titer, from 697 ± 120 to 829 ± 117) administrations. To assess the protective effects of the vaccine, ferrets from the vaccinated and control groups were infected intranasally with pandemic virus A/California/7/09 (H1N1) pdm09 at a dose of 10(6) EID(50)/0.5 mL. Fourteen days post-infection, the ferrets inoculated with single or double vaccines containing 3.75, 7.5 or 15.0 μg of hemagglutinin per dose showed no signs of influenza infection, weight loss, or body temperature rise, and no premature deaths occurred. The number of vaccinated ferrets shedding the virus via the upper airway, as well as the amount of virus shed after infection, was significantly reduced in comparison with animals from the control group. Based on our results, we suggest that a single vaccination at a dose of 3.75 or 7.5 μg hemagglutinin be used for Phase I clinical trials.
authors.affiliation: Research Institute for Biological Safety Problems, Gvardeiski 080409, Kazakhstan. tabynov_81@mail.ru
authors.forename: Kaissar
authors.initials: K
authors.lastname: Tabynov
authors.forename: Zhailaubai
authors.initials: Z
authors.lastname: Kydyrbayev
authors.forename: Abylai
authors.initials: A
authors.lastname: Sansyzbay
authors.forename: Berik
authors.initials: B
authors.lastname: Khairullin
authors.forename: Sholpan
authors.initials: S
authors.lastname: Ryskeldinova
authors.forename: Nurika
authors.initials: N
authors.lastname: Assanzhanova
authors.forename: Yerken
authors.initials: Y
authors.lastname: Kozhamkulov
authors.forename: Dulat
authors.initials: D
authors.lastname: Inkarbekov
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D002642:Chick Embryo; D004195:Disease Models, Animal; D005260:Female; D005289:Ferrets; D006385:Hemagglutination Inhibition Tests; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000276:immunology; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology*; D007273:Injections, Intramuscular; D007623:Kazakhstan; D009976:Orthomyxoviridae Infections / Q000276:immunology / Q000473:pathology / Q000517:prevention & control*; D016019:Survival Analysis; D014611:Vaccination / Q000379:methods; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000276:immunology; D017201:Virus Shedding
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D019267:Hemagglutinin Glycoproteins, Influenza Virus; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated