title: Yearly licensing studies from 1997 to 2007 of the inactivated whole virus seasonal influenza vaccine fluval--a useful approach to pandemic vaccine development even in less well developed countries?
abstract: OBJECTIVE
  Seasonal vaccination has been consistently shown to significantly reduce morbidity and mortality because of influenza epidemics, even in healthy, working adults. Here we report the results of the yearly licensing studies of the past 11 influenza seasons (1997-2007) with a trivalent, inactivated whole virus vaccine with an aluminum phosphate adjuvant system.
  
  
  METHODS
  Sixty healthy volunteers per age group (18-60 years and 60 years and older) were enrolled to receive vaccination each year, thus, a total of 1080 subjects were studied. Serum antibody titers were measured by hemagglutination inhibition (HI).
  
  
  RESULTS
  The vaccine met the criteria for licensing each year, meaning seroprotection (achievement of an HI titer of >1:40 in >70% of subjects); seroconversion, i.e. a >4-fold increase in HI antibody titer, or reaching a titer of >1:40, in >40% of subjects; and an increase in geometric mean titers by >2.5-fold. Side effects were rare and mild. The same method was used to produce a pre-pandemic vaccine against influenza A (H5N1), which has been shown to be safe and immunogenic in humans.
  
  
  CONCLUSIONS
  We conclude that the method presented is safe, effective and may serve as a useful approach to seasonal and pandemic vaccine production even in less well-developed countries by means of technological transfer.
authors.affiliation: National Center for Allergy and Immunology, Budapest, Hungary.
authors.forename: Zoltan
authors.initials: Z
authors.lastname: Vajo
authors.forename: Lajos
authors.initials: L
authors.lastname: Kosa
authors.forename: Istvan
authors.initials: I
authors.lastname: Szilvasy
authors.forename: Zsuzsanna
authors.initials: Z
authors.lastname: Pauliny
authors.forename: Kálmán
authors.initials: K
authors.lastname: Bartha
authors.forename: Ildiko
authors.initials: I
authors.lastname: Visontay
authors.forename: Mate
authors.initials: M
authors.lastname: Jankovics
authors.forename: Agnes
authors.initials: A
authors.lastname: Kis
authors.forename: Istvan
authors.initials: I
authors.lastname: Jankovics
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000494:pharmacology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017607:Aluminum Compounds / Q000008:administration & dosage / Q000494:pharmacology; D000914:Antibodies, Viral / Q000097:blood; D017277:Drug Approval; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000008:administration & dosage / Q000494:pharmacology; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D017607:Aluminum Compounds; D000914:Antibodies, Viral; D007252:Influenza Vaccines; D010710:Phosphates; D015164:Vaccines, Inactivated; C012714:aluminum phosphate