CSL

The advent of the global pandemic influenza threat in April this year required an immediate response from CSL scientists to develop a vaccine.

Pandemic vaccine clinical trials

By 22 July, clinical trials of CSL’s Novel Type A (H1N1) ‘swine’ influenza vaccine commenced in Adelaide, South Australia.

The candidate vaccine being tested in the clinical trials was produced using CSL’s well established, large scale production technologies. The purpose of this clinical trial is to establish an optimum vaccine dose for protection against this new strain of influenza. Both a standard dose (15 mcg) and a higher dose (30 mcg) are being tested.

Two hundred and forty healthy adult volunteers aged 18 to 64 are taking part in the trial at the Royal Adelaide Hospital. Each volunteer receives two doses of the candidate vaccine three weeks apart, with blood tests taken to measure the strength and appropriateness of the immune response. As with any of our clinical trials, the safety of the vaccine is also being monitored.

In August, clinical trials in children commenced using the same dosing with 400 healthy volunteers aged six months to nine years taking part. Additional studies are being carried out in the United States.

Data from these clinical trials will help governments decide how best to deploy the H1N1 vaccine as it becomes available.

CSL has a global role

CSL operates one of the largest influenza vaccine manufacturing facilities in the world at our Parkville site in Melbourne and has more than 40 years experience in the production of these vaccines.

The WHO Global Influenza Surveillance Network collects samples of influenza virus throughout the year and determines which new strains in the constantly changing viruses are becoming dominant. As usual, this year the WHO provided CSL with virus samples including those from which our pandemic vaccine has been developed.

CSL scientists take the candidate WHO viruses through a process known as reassortment to create viruses with good vaccine properties, and that will grow well in eggs. The seed lots obtained through this process are used to produce our influenza vaccines.

As one of only three laboratories in the world that produces the Type A virus seed lots for the World Health Organisation (WHO), CSL has a global role in developing pandemic and seasonal influenza vaccines.

During the past 10 years, all the Type A seasonal H1N1 viruses used by manufacturers worldwide to produce influenza vaccine have been from seed virus developed by scientists at CSL.