GSK also reported the start of the first North American pre-pandemic vaccine trials in the company’s global pre-pandemic influenza program.
The company has received a second task order for 22.5 million doses of 15mcg H5N1 bulk vaccine antigen from the HHS under a contract awarded in November 2007. This is in addition to the 5 million doses of vaccine ordered in November 2006.
Under the terms of the contract, GSK will manufacture the bulk vaccine product at the GSK manufacturing site in Canada and store bulk H5N1 antigen at the GSK site in Pennsylvania. Terms of the contract also state that GSK may be directed by HHS to formulate this bulk antigen at some point in the future.
Additionally, HHS also has the option to purchase pre-pandemic vaccines together with one of GSK’s proprietary adjuvant systems, which could mean that less antigen would be needed per dose to achieve a protective immune response.
Commenting on the company’s pre-pandemic vaccine trials, Ripley Ballou, vice president of clinical development for flu at GlaxoSmithKline said: “The goal of our North American clinical development program is to establish GSK’s second manufacturing facility 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.”
This Phase I/II study, which will be conducted in seven states in the US and two provinces in Canada, is an observer-blind, randomized, active-controlled trial that will evaluate the safety and immunogenicity of two consecutive doses of H5N1 pre-pandemic vaccine.
The vaccine containing H5N1 antigen alone will be evaluated against a vaccine containing H5N1 antigen in combination with the adjuvant system, in 675 adult volunteers aged between 18 and 64 years. Results from this study will be available in early 2008.