Trials of a new vaccine to protect humans from the H5N1 Bird Flu strain have had promising results, said a spokesperson for Sanofi-Aventis.
According to the company, the preliminary results of clinical trials showed a good immune response in a significant number of volunteers.
This is the first trial of an H5N1 pre-pandemic influenza vaccine candidate compared vaccines with and without adjuvants.
The company added that the vaccine is safe and well tolerated. 300 healthy volunteers are taking part in the trial.
A 30 microgram dose with an adjuvant in a two-dose regimen showed an immune response at levels consistent with requirements of regulatory agencies for licensure of seasonal influenza vaccine.
The company also noticed that immune responses were detected in a number of volunteers receiving lower doses.
Further trials will explore different dosages. This may be useful in answering questions about dose-sparing strategies.
The trial took place in Necker and Cochin Hospitals, Paris, and Garches Hospital, France, with Professor Jean-Louis Bresson as the principal researcher.
The vaccine used the reference strain provided by the British National Institute for biological Standards and control (NIBSC). Assays were performed at NIBSC and the British Health Protection Agency (HPA).
Sanofi-Aventis (Sanofi-Pasteur) is contracted by the Ministry of Health, France, to deliver 1,400,000 vaccines by the end of 2005.
Sanofi-Pasteur is the vaccine division of the French pharmaceutical giant, Sanofi-Aventis.
Written by: Christian Nordqvist
Editor: Medical News Today