A phase I clinical trial of a PER.C6® cell grown influenza H7 virus vaccine

Rebecca J. Cox, Abdullah S. Madhun, Solveig Hauge, Haakon Sjursen, Diane Major, Mirjam Kuhne, Katja Hoschler, Melanie Saville, Frederick R. Vogel, Wendy Barclay, Isabella Donatelli, Maria Zambon, John Wood, Lars R. Haaheim

Research output: Contribution to journalArticlepeer-review

134 Citations (Scopus)

Abstract

Avian influenza H7 viruses have transmitted from poultry to man causing human illness and fatality, highlighting the need for pandemic preparedness against this subtype. We have developed and tested the first cell-based human vaccine against H7 avian influenza virus in a phase I clinical trial. Sixty healthy volunteers were intramuscularly vaccinated with two doses of split H7N1 virus vaccine containing 12 μg or 24 μg haemagglutinin alone or with aluminium hydroxide adjuvant (300 μg or 600 μg, respectively). The vaccine was well tolerated in all subjects and no serious adverse events occurred. The vaccine elicited low haemagglutination inhibition and microneutralisation titres, although the addition of aluminium adjuvant augmented the antibody response. We found a higher number of antibody secreting cells and an association with IL-2 production in subjects with antibody response. In conclusion, our study shows that producing effective H7 pandemic vaccines is as challenging as has been observed for H5 vaccines.

Original languageEnglish
Pages (from-to)1889-1897
Number of pages9
JournalVaccine
Volume27
Issue number13
DOIs
Publication statusPublished - 18 Mar 2009

Keywords

  • Human
  • Influenza H7
  • Vaccine

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