Progress on pandemic flu vaccine
NIBSC/Science Photo Library
H5N1 influenza virus, shown here, is the basis for the vaccine |
An investigational H5N1 pandemic influenza vaccine developed by GlaxoSmithKline has yielded promising results in a recent clinical trial, the company has revealed. Preliminary data — reviewed internally by the company — show
that over 80 per cent of subjects vaccinated obtained a strong seroprotective
immune response to 3.8µg of antigen, the lowest dosage assessed.
The trial, conducted in Belgium, involved 400 adults who received two
doses of a vaccine containing both inactivated H5N1 virus and a new proprietary
adjuvant designed to augment the immune system’s response to the
vaccine.
JP Garnier, GSK’s chief executive officer, commented: “This
is the first time such a low dose of H5N1 antigen has been able to stimulate
this level of strong immune response. There is still a lot more work
to be done with this programme, but this validation of our approach provides
us with the confidence to continue developing the vaccine, including
assessment of its ability to offer cross protection to variants of the
H5N1 strain.”
GSK has submitted a “mock-up dossier” to the European Medicines
Agency and will supplement its submission with further trial data on
the ability of the vaccine to cover for potential “drift”,
a company spokeswoman told The Journal. She explained that drift is any
slight variation in the virus, which could make the vaccine — based
on Vietnamese H5N1 influenza — less effective. |
The
Pharmaceutical Journal
Acrobat
Reader