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?

Z. Vajó, Lajos Kosa, Istvan Szilvasy, Zsuzsanna Pauliny, Kálmán Bartha, Ildiko Visontay, Mate Jankovics, Agnes Kis, Istvan Jankovics

Research output: Contribution to journalArticle

5 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)211-218
Number of pages8
JournalInfluenza and other Respiratory Viruses
Volume2
Issue number6
DOIs
Publication statusPublished - 2008

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Influenza Vaccines
Hemagglutination
Pandemics
Licensure
Developing Countries
Vaccines
Human Influenza
Vaccination
Antibodies
Healthy Volunteers
Age Groups
Viruses
Morbidity
Mortality
Serum
Inhibition (Psychology)

Keywords

  • Influenza
  • Licensing
  • Seasonal
  • Vaccine

ASJC Scopus subject areas

  • Infectious Diseases
  • Pulmonary and Respiratory Medicine
  • Public Health, Environmental and Occupational Health
  • Epidemiology

Cite this

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? / Vajó, Z.; Kosa, Lajos; Szilvasy, Istvan; Pauliny, Zsuzsanna; Bartha, Kálmán; Visontay, Ildiko; Jankovics, Mate; Kis, Agnes; Jankovics, Istvan.

In: Influenza and other Respiratory Viruses, Vol. 2, No. 6, 2008, p. 211-218.

Research output: Contribution to journalArticle

Vajó, Z. ; Kosa, Lajos ; Szilvasy, Istvan ; Pauliny, Zsuzsanna ; Bartha, Kálmán ; Visontay, Ildiko ; Jankovics, Mate ; Kis, Agnes ; Jankovics, Istvan. / 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?. In: Influenza and other Respiratory Viruses. 2008 ; Vol. 2, No. 6. pp. 211-218.
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