title: [Evaluation of immunogenicity and safety of 2 immunizations with allantoic intranasal live influenza vaccine Ultragrivac].
abstract: OBJECTIVE
  Evaluate reactogenicity, safety and immunogenicity in phase 2 clinical trials of 2 immunization schedules with Ultragrivac--an allantoic intranasal life influenza vaccine based on A/17/ duck/Potsdam/86/92 [17/H5] reassortant strain.
  
  
  METHODS
  4 groups of volunteers participated in the study: group 1--40 individuals were vaccinated twice with a 10 day interval; group 2--40 individuals were vaccinated twice with a 21 day interval; group 3 (control)--10 individuals received placebo twice with a 10 day interval; group 4 (control)--10 individuals received placebo twice with a 21 day interval. Local (secretory IgA), cellular and humoral immune response were evaluated. Humoral immunity was evaluated by the intensity of increase of geometric mean antibody titers against 2 influenza virus strains A/17/duck/Potsdam/86/92 [17/H5] and A/chicken/Suzdalka/Nov-1 1/2005 (H5N1), and by the level of significant (4 times or more) antibody seroconversions after the vaccination.
  
  
  RESULTS
  After the use of Ultragrivac the level of secretory IgA in the nasal cavity of vaccinated volunteers in the groups with revaccination intervals of 10 and 21 days increased significantly. The second immunization with 10 or 21 day intervals significantly increased postvaccinal humoral immune response. Humoral immune response induction after 2 vaccinations with 10 day interval was no less effective than with 21 day interval.
  
  
  CONCLUSIONS
  Ultragrivac allantoic intranasal live influenza vaccine is areactogenic, harmless for vaccinated individuals, safe for those around, and has immunogenic properties against not only homologous virus A(H5N2), but also against influenza strain A(H5N1).
authors.forename: L N
authors.initials: LN
authors.lastname: Shishkina
authors.forename: N A
authors.initials: NA
authors.lastname: Mazurkova
authors.forename: V A
authors.initials: VA
authors.lastname: Ternovoĭ
authors.forename: L E
authors.initials: LE
authors.lastname: Bulychev
authors.forename: Iu V
authors.initials: IuV
authors.lastname: Tumanov
authors.forename: M O
authors.initials: MO
authors.lastname: Skarnovich
authors.forename: A S
authors.initials: AS
authors.lastname: Kabanov
authors.forename: N N
authors.initials: NN
authors.lastname: Ryndiuk
authors.forename: V I
authors.initials: VI
authors.lastname: Kuzubov
authors.forename: A N
authors.initials: AN
authors.lastname: Mironov
authors.forename: E A
authors.initials: EA
authors.lastname: Stavskiĭ
authors.forename: I G
authors.initials: IG
authors.lastname: Drozdov
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000818:Animals; D005260:Female; D006801:Humans; D056724:Immunity, Humoral; D007117:Immunization, Secondary; D053124:Influenza A Virus, H5N1 Subtype; D053125:Influenza A Virus, H5N2 Subtype; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D007252:Influenza Vaccines; C561662:Ultragrivac; D014613:Vaccines, Attenuated