The first trial, which has recruited 400 healthy adult volunteers in Germany, is testing a pandemic flu vaccine using a classic alum adjuvant to improve individuals’ immune response and possibly allow a lower amount of antigen to be used per dose.
The second study, a clinical trial conducted in Belgium in 400 healthy adults, is testing a possible pandemic flu vaccine that contains a novel adjuvant system. GSK hopes this novel adjuvant will require smaller doses than existing therapies, increasing the company’s manufacturing capacity for the vaccine. Such a vaccine would offer governments additional options of stockpiling and vaccinating ahead of a pandemic outbreak.
Both trials are testing the vaccine’s safety and ability to boost individuals’ immune response against H5N1. Tested vaccines are made from inactivated (killed) H5N1 virus. Different dose levels are being studied. Volunteers are to receive two vaccinations approximately three weeks apart. The studies will allow GSK to select an optimal dose and formulation for subsequent safety trials in groups at high risk of complications following influenza infection, such as children and the elderly.
Preliminary results from the clinical trials are expected in the third quarter of 2006. GSK plans to have a pandemic flu vaccine in production before the end of the year.
“While the first vaccine candidate aims at mounting a strong defense against a pandemic outbreak, the second vaccine may offer governments a preferred option to proactively stockpile and begin vaccination before the onset of a pandemic, significantly increasing the speed of a public health response in the event of an outbreak,” said Jean Stephenne, president of GSK’s vaccine division.