GSK starts first trials for H1N1 vaccine in Germany
pharmafile | August 17, 2009 | News story | Research and Development, Sales and Marketing | GSK, h1n1, vaccines
GSK is to embark on the clinical development for its pandemic swine flu vaccine, completing enrolment into its first study in Germany.
The company begins trials just slightly behind a few others in the race to develop a vaccine, such as Baxter, Novartis and CSL in Australia.
GSK is contracted to produce around 195 million doses to governments worldwide – a significant amount which could see it stand to make most money from the pandemic.
Dr Thomas Breuer, head of global clinical R&D and chief medical officer of GSK Biologicals, said GSK was making good progress with the development of its pandemic vaccine.
He added: "Enrolment into the first study has been completed and in total, GSK will conduct 16 clinical trials of its pandemic vaccine in over 9,000 individuals across Europe, Canada and the US. We continue to work closely with regulators and governments to assess and develop this vaccine."
GSK's vaccine will comprise antigen of the isolated Pandemic (H1N1) 2009 influenza strain, recently issued by the WHO, and will also contain its own adjuvant system AS03.
Adjuvants are a new technology that boosts the potency of antigen, meaning the same volume of vaccine can be split into more doses, substantially increasing the number of jabs that can be provided for mass vaccination. Novartis is the only other company producing injections with this technology.
GSK said in clinical studies using the bird flu influenza strain (H5N1), its adjuvanted formulation has been shown to stimulate a higher immune response while using a smaller amount of antigen as compared to a formulation without adjuvant, and hopes the same thing will happen again.
The first clinical trial for H1N1 being conducted in Germany will assess the use of the vaccine in healthy adults, and the company expects to share initial data with regulatory authorities in September.
Further trials covering infants, children, adults and the elderly will commence over the coming weeks across Europe, Canada and the US. The clinical development programme, which has been designed in close partnership with regulatory authorities, will evaluate the immune response as well as tolerability and other safety aspects of the vaccine.
All the final data on the clinical development programme will be submitted to the regulators as soon as they are available and will be posted on GSK's Clinical Study Register.
GSK, along with Baxter, are producing vaccines for the UK, which the government expects by Autumn.
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