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

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

来源：Vaccine, 2009, 27(13): 1889-1897.

DOI：10.1016/j.vaccine.2009.01.116

• Influenza H7
• Human
• Vaccine

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 mu g or 24 mu g haemagglutinin alone or with aluminium hydroxide adjuvant (300 mu g or 600 mu g, 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.

• 出版日期2009-3-18