A phase I clinical trial of a PER.C6 cell grown influenza H7 virus 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 microg or 24 microg haemagglutinin alone or with aluminium hydroxide adjuvant (300 microg or 600 microg, 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.
Cox
Rebecca J
RJ
Influenza Centre, The Gade Institute, University of Bergen, N-5021 Bergen, Norway. rebecca.cox@gades.uib.no
Madhun
Abdullah S
AS
Hauge
Solveig
S
Sjursen
Haakon
H
Major
Diane
D
Kuhne
Mirjam
M
Höschler
Katja
K
Saville
Melanie
M
Vogel
Frederick R
FR
Barclay
Wendy
W
Donatelli
Isabella
I
Zambon
Maria
M
Wood
John
J
Haaheim
Lars R
LR
D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000328:Adult; D000536:Aluminum Hydroxide / Q000276:immunology; D000914:Antibodies, Viral / Q000097:blood / Q000276:immunology; D000917:Antibody Formation; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood / Q000276:immunology; D007074:Immunoglobulin G / Q000097:blood / Q000276:immunology; D009980:Influenza A virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D007376:Interleukin-2 / Q000097:blood / Q000276:immunology; D008297:Male; D009500:Neutralization Tests; D014613:Vaccines, Attenuated / Q000276:immunology; D055815:Young Adult
D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; C508594:IL2 protein, human; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D007252:Influenza Vaccines; D007376:Interleukin-2; D014613:Vaccines, Attenuated; D000536:Aluminum Hydroxide