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CSL reveals encouraging results from Australian bird flu vaccine trial |
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17 Feb 2006 |
CSL Limited, Australia’s leading biopharmaceutical company, has today announced encouraging preliminary results of its initial clinical trial of a pandemic influenza vaccine, based on the H5N1 avian virus.
VICTORIA, Australia | Feb 17, 2006 | The Australian trial, conducted at the Murdoch Children’s Research Institute in conjunction with Melbourne University and the Royal Adelaide Hospital, has shown the candidate vaccine to be well-tolerated in the study population. Importantly it confirmed that when used in conjunction with a stimulant, or ‘adjuvant’, two standard doses of the vaccine will create an appropriate human immunological response in a significant number of volunteers.
‘We have learned three very important facts from this trial’ Professor Terry Nolan, the Principal Investigator said today.
‘Firstly, we can confirm it is actually possible to vaccinate humans against this bird virus using existing technology; secondly, we know we will need to use two doses of a candidate vaccine and an adjuvant to achieve a satisfactory immune response; and finally, we will need to do further research to trial a higher dose of vaccine across a wider age range so that we can protect as many people as possible, and demonstrate safety,” Professor Nolan said.
‘CSL will continue to work closely with the Therapeutic Goods Administration (TGA), on the development of a core pandemic vaccine dossier, so that we can be ready to produce a safe and effective vaccine in the event of a pandemic’ Dr Andrew Cuthbertson, Chief Scientific Officer at CSL Ltd, added.
‘We will be discussing what further trial work needs to be done to determine the optimum dose of antigen needed as part of the final vaccine program.’ Dr Cuthbertson said.
The Office of the Gene Technology Regulator (OGTR) has also licensed CSL’s influenza vaccine manufacturing facility to make the pandemic vaccine, giving CSL the capability to produce antigen for further clinical trials and a vaccine stockpile as soon as required. CSL acknowledges the crucial role of the Federal Health Minister Tony Abbott in enabling the OGTR approval, and accelerating the pandemic vaccine clinical trial program through a contribution of $4.93 million last year.
CSL has recently announced that it will be doubling its manufacturing capacity, which will put the company in an excellent position to respond to the need for influenza vaccine should a pandemic occur in future.
SOURCE: CSL Limited |
