title: [Immunogenicity of inactivated subunit adsorbed monovalent vaccine against influenza A/California/7/2009 (H1N1) strain].
abstract: The immunogenicity of Pandeflu subunit vaccine against influenza A/California/7/2009 (H1N1) was evaluated in 70 healthy volunteers aged 18 to 60 years. The vaccine was intramuscularly injected twice at an interval of 28 days. Each dose (0.5 ml) contains A(HIN1) influenza virus hemagglutinin (15 +/- 2.2 microg), aluminum hydroxide (Denmark) (0.475 +/- 0.075 microg), and the preservative thiomerosal (merthiolate) (50 +/- 7.5 microg). The level of antibodies was determined in the microneutralization assay. After administration of two doses of the vaccine at a 28-day interval, the geometric mean antibody titer (GMAT) reached 1:21.1 with a further increase to 1:30 (the baseline GMAT) was 1:6.1). The frequencies of seroconversion and seroprotection were 71.4 and 59.2%, respectively; the antibody increase factor was 4.92, which meets the CPMP criteria. The administration of the vaccine did not result in adverse reactions in the postvaccination period.
authors.forename: V V
authors.initials: VV
authors.lastname: Zverev
authors.forename: M P
authors.initials: MP
authors.lastname: Kostinov
authors.forename: N A
authors.initials: NA
authors.lastname: Mikhailova
authors.forename: S N
authors.initials: SN
authors.lastname: Zhirova
authors.forename: A N
authors.initials: AN
authors.lastname: Mironov
authors.forename: O A
authors.initials: OA
authors.lastname: Terkacheva
authors.forename: A A
authors.initials: AA
authors.lastname: Romanova
authors.forename: A P
authors.initials: AP
authors.lastname: Cherdantsev
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000328:Adult; D000536:Aluminum Hydroxide / Q000008:administration & dosage; D000914:Antibodies, Viral / Q000096:biosynthesis*; D002140:California; D058872:Epidemics / Q000517:prevention & control; D005260:Female; D006388:Hemagglutinins / Q000737:chemistry / Q000276:immunology; D006801:Humans; D056724:Immunity, Humoral / Q000187:drug effects; D053118:Influenza A Virus, H1N1 Subtype / Q000737:chemistry* / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000138:chemical synthesis / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009500:Neutralization Tests; D012426:Russia; D013849:Thimerosal / Q000008:administration & dosage; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000138:chemical synthesis / Q000276:immunology*; D022223:Vaccines, Subunit / Q000008:administration & dosage / Q000138:chemical synthesis / Q000276:immunology*
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D006388:Hemagglutinins; D007252:Influenza Vaccines; D014613:Vaccines, Attenuated; D022223:Vaccines, Subunit; D013849:Thimerosal; D000536:Aluminum Hydroxide