Sanofi Pasteur Inc.

Sanofi Pasteur Sa

Sandrine Lentsch Graf

Isabelle Chacornac

Nabila Ikhelef-Gribi

Julien Tirefort

Alain Françon

Alain Francon

Frederic Ronzon

Landry Bertaux

Jean-François Hau

Frédéric Ronzon

Jean-Francois Hau

The invention relates to a method for loading and storing a vaccine composition, containing the antigen adsorbed on the aluminum adjuvant which (a) comprises (i) loading the composition into a container; and (ii) closing the container with a device in particular acting as a stopper, the surface of the device getting into contact with the composition being coated with a fluoropolymer such as Teflon&#x2122; and/or (b) loading the composition into a container wherein the inner surface of which is coated with polymerized silicone. The use of fluoropolymer or polymerized silicone optimizes the adsorbed antigen stability upon storage. In a particular embodiment, the antigen is the hepatitis B surface antigen and the aluminum adjuvant is aluminum oxy hydroxide.

Method of storing a vaccine containing an aluminum adjuvant

The subject matter of the invention is a method for preparing a vaccine composition comprising at least aluminum oxyhydroxide (AlOOH), and at least the hepatitis B surface antigen and thetype b antigen. According to the invention, the hepatitis B surface antigen is kept adsorbed on the AlOOH, whereas the Hib antigen is kept nonadsorbed. To this end: the hepatitis B surface antigen is adsorbed onto AlOOH in order to obtain an AlOOH/HBsAg complex, then&#x2014;said AlOOH/HBsAg complex is mixed with the Hib antigen in the presence of cationic amino acids at a concentration of at least 100 mg/l, and of phosphate ions at a concentration of 35 to 45 mMol/l.

Method for formulating a vaccine containing at least two antigens capable of adsorbing onto aluminium oxyhydroxide

The invention relates to a method for loading and storing a vaccine composition, containing the antigen adsorbed on the aluminum adjuvant which (a) comprises (i) loading the composition into a container; and (ii) closing the container with a device in particular acting as a stopper, the surface of the device getting into contact with the composition being coated with a fluoropolymer such as Teflon&#x2122;; and/or (b) loading the composition into a container wherein the inner surface of which is coated with polymerized silicone. The use of fluoropolymer or polymerized silicone optimizes the adsorbed antigen stability upon storage. In a particular embodiment, the antigen is the hepatitis B surface antigen and the aluminum adjuvant is aluminum oxy hydroxide.

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Sainte Foy Les Lyon, France

Sandrine Lentsch Graf