Sanofi Pasteur has completed production of the first clinical trial materials for its new generation of H7N1 pandemic influenza vaccine and says it will be able to move ahead with patient recruitment.
Like the notorious H5N1 strain of the virus, H7N1 is a bird flu that may be able jump the species barrier between poultry and humans. H7N1 caused lethal outbreaks in Italian poultry in 1999 and was subsequently shown to be related to the 2003 H7N7 poultry virus in the Netherlands, which was responsible for over 80 human infections and one death.
This trial broadens the company’s pandemic flu development programme, which has already achieved notable successes such as securing a $150 million contract to supply a candidate H5N1 vaccine to the US government. This vaccine has already started clinical testing at the US National Institute of Allergy and Infectious Diseases.
This Phase I clinical trial of the H7N1 strain is getting underway today in Bergen, Norway, and is the first to assess the safety of a split, inactivated prototype pandemic H7N1 vaccine produced in cells rather than eggs, as well as its ability to generate an immune response. The vaccine is made in Crucell’s PER.C6 cell line, which is increasingly
A total of 60 healthy adults will be vaccinated with one of four formulations: two dosages - 12 micrograms and 24 micrograms – of the H7N1 antigen with or without an aluminum hydroxide as an adjuvant.
The vaccine has been developed as part of the European FLUPAN initiative, a consortium of European academic, industry and regulatory groups. FLUPAN selected H7N1 as a target because it was thought to be the most likely pandemic flu candidate when the project got underway in 2001.