CSL is starting a trial of a vaccine for Swine Flu this week amongst people aged 18 to 64. There’s a great interview here with Dr Rachel David from CSL, by Fran Kelly today at ABC Radio National. The key point from this interview is that the trial is about efficacy, not safety. CSL is doing the trial to see how big the dose needs to be (or if two need to be given). Apparently with fresh strains, it’s often the case that people need a double dose. The risk they’re running in the UK, by not doing a trial on the vaccine, is not so much a public safety risk, as the risk that the dose will prove insufficient and they will have to go back to everyone they’ve immunised and give them another jab.
Here’s a copy of the press release from CSL in late June about this trial:
Trial of Novel H1N1 ‘Swine’ Flu candidate vaccine to take place in Adelaide
Melbourne, Australia — 29/06/2009
CSL Limited, Australia’s leading biopharmaceutical company, will shortly be commencing a clinical trial of a candidate vaccine against Novel H1N1 ‘Swine’ Flu. The trial will be undertaken in partnership with Clinical Research Organisation CMAX and the Royal Adelaide Hospital in South Australia.
Healthy adults aged between 18 and 64 years are being sought to participate, and must be available to meet four appointments in Adelaide over a 6 month period.
The trial will involve participants receiving two injections of the vaccine, three weeks apart, and will compare a standard with an increased dosage of vaccine. Volunteers will need to submit to blood tests to check that they are generating an appropriate immune response to the virus.
“We understand flu vaccines very well from our long experience with yearly seasonal strains, as well as research into novel flu vaccines.” Global Director of Clinical Development at CSL, Dr Russell Basser said today.
“We appreciate that new influenza strains like the ‘swine flu’ can surprise us with properties that mean they might require higher dosing and two injections rather than one to provoke the desired level of immune response in humans.”
“CSL will be addressing these questions in the trial to ensure we know the optimum way for the vaccine to be given to protect against this strain of flu.”
It is anticipated that participants in the trial will commence being vaccinated in mid-July. This trial is being conducted with view to fulfilling a commitment to the Australian Department of Health and Ageing to supply up to 10 million people with a vaccine against Novel H1N1 ‘swine’ influenza.