GSK, which has its Canadian headquarters in Meadowvale, is starting North America's first trials for a drug that would help fight the deadly bird flu or any other strain of the virus that could lead to a global flu pandemic.
The trials are part of the company's global pre-pandemic influenza program. GSK officials say the goal is to create a vaccine that would help boost immune systems against the H5N1 flu virus, one strain of which is known as "avian flu" or "bird flu."
If a pandemic hit, it would take up to six months to inoculate people against a specific strain of the H5N1 virus. If successful, the pre-pandemic vaccine GSK is testing would keep people healthy while they wait for the strain-specific vaccine.
GSK's product development and manufacturing operation is located at the Meadowvale plant, but the vaccine to be used in the trials will be produced at the company's Quebec facility.
The first two phases of the trial will study 675 participants, with the third phase of the trial, scheduled for later this year, expected to be a much larger, multi-centre trial, with 4,400 subjects.
Ripley Ballou, GSK vice-president of clinical development for flu, said, "The goal of our North American clinical development program is to establish GSK's second manufacturing facility (Quebec) as a source for H5N1 vaccine, further strengthening our efforts to support governments' pandemic preparedness strategies. The initiation of these trials underscores the importance of GSK's $2-billion investment in 2005 to create a new influenza vaccine infrastructure in North America."
It was widely reported last year that companies making and testing H5N1 vaccines were getting a low yield of a key component. According to the World Health Organization (WHO), without better results, the number of people that could be vaccinated in the first year of a pandemic would be very low.
WHO called for increased research to solve the problem, and GSK officials believe they've answered the call.
The first two phases of the study will take place in seven U.S. states and two provinces in Canada. The trial will test the safety and immunogenicity of two consecutive doses of the H5N1 pre-pandemic vaccine.
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