title: [Results of clinical trials on reactogenicity, safety, and immunogenicity of influenza allantoic intranasal live vaccine "Ultragrivac" (type A/H5N2)].
abstract: Results of phase II of a clinical trial of the influenza allantoic intranasal live vaccine "Ultragrivac" (type A/H5N2) are presented. The vaccine was developed based on strain /17/Duck/Potsdam/86/92 H5N2 [17/H5] - reassortant of two viruses, /Leningrad/134/17/57 (H2N2) and /Duck/Potsdam/1402-86 (H5N2), obtained from the Virology Department, St. Petersburg Institute of Experimental Medicine.Two schemes of immunization (with revaccination on days 10 and 21) were used. Evaluation of vaccine immunogenicity included determination of local, cellular and humoral immunity. A significant rise in the level of secretory IgA in the nasal cavity of vaccinated volunteers (with revaccination on days 10 and 21) was documented after application of the vaccine. The postvaccination humoral immune response was estimated from the level of significant (4-fold and more) antibody seroconversions, geometric mean titers of antibodies to two strains of influenza virus /17/Duck/Potsdam/86/92 H5N2 [17/H5] and /Chicken/Suzdalka/Nov-11/2005 (H5N1), and their incremental rate. Results of measurement of antibody titers in hemagglutination-inhibition assay are presented, with two antigens being used to analyse all serum samples from volunteers twice vaccinated with influenza vaccine "Ultragrivac" at 10 and 21 day intervals. Result of phase II of this clinical study show that influenza allantoic intranasal live vaccine "Ultragrivac" is nonreactogenic and safe for both vaccinated and surrounding individuals. Moreover, it is sufficiently immunogenic with respect not only to homologous virus A(H5N2) but also to the A(H5N1) strain.
authors.forename: N A
authors.initials: NA
authors.lastname: Mazurkova
authors.forename: N N
authors.initials: NN
authors.lastname: Ryndiuk
authors.forename: L N
authors.initials: LN
authors.lastname: Shishkina
authors.forename: V A
authors.initials: VA
authors.lastname: Ternovoĭ
authors.forename: Iu V
authors.initials: IuV
authors.lastname: Tumanov
authors.forename: L E
authors.initials: LE
authors.lastname: Bulychev
authors.forename: M O
authors.initials: MO
authors.lastname: Skarnovich
authors.forename: A S
authors.initials: AS
authors.lastname: Kabanov
authors.forename: S G
authors.initials: SG
authors.lastname: Panchenko
authors.forename: R P
authors.initials: RP
authors.lastname: Aleĭnikov
authors.forename: T N
authors.initials: TN
authors.lastname: Il'ina
authors.forename: V I
authors.initials: VI
authors.lastname: Kuzubov
authors.forename: S Ia
authors.initials: SIa
authors.lastname: Mel'nikov
authors.forename: A N
authors.initials: AN
authors.lastname: Mironov
authors.forename: S A
authors.initials: SA
authors.lastname: Korovkin
authors.forename: A N
authors.initials: AN
authors.lastname: Sergeev
authors.forename: I G
authors.initials: IG
authors.lastname: Drozdov
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology; D053125:Influenza A Virus, H5N2 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology; D008297:Male; D008875:Middle Aged; D016865:Reassortant Viruses / Q000276:immunology; D014611:Vaccination; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines