Method of Storing a Vaccine Containing an Aluminum Adjuvant

• US 20120091026A1
• Filed: 10/17/2011
• Published: 04/19/2012
• Est. Priority Date: 10/18/2010
• Status: Active Grant

• Current Assignee: Sanofi Pasteur SA (Sanofi )
• Original Assignee: Sanofi Pasteur SA (Sanofi )
• Inventors: Chacornac, Isabelle, Ikhelef-Gribi, Nabila, Ronzon, Frédéric, Tirefort, Julien, Lentsch Graf, Sandrine
• Granted Patent: US 9,066,895 B2
• Time in Patent Office: Days
• US Class Current: 206/524.3
• CPC Class Codes: A61K 2039/55505 Inorganic adjuvants
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 39/05 Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella, Corynebacterium; Propionibacterium Mycobacterium A61K39/04
• CPC Class Codes: A61K 39/08 Clostridium, e.g. Clostridium tetani
• CPC Class Codes: A61K 39/099 Bordetella
• CPC Class Codes: A61K 39/292 Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 31/20 for DNA viruses
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 7/2821 applying plugs or threadless stoppers for bottles or jars B67B1/04
• CPC Class Codes: B65D 51/002 Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
• CPC Class Codes: B65D 51/005 Closures provided with linings or internal coatings so as to avoid contact of the closure with the contents
• CPC Class Codes: C12N 2730/10134 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 7/00 Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

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™; 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.

Claims

1. A method for storing a vaccine composition containing an antigen adsorbed on an aluminum adjuvant, the method comprising (i) loading the composition into a container and (ii) closing the container with a device acting as a stopper, wherein the surface of the device contactable with the composition is coated with a fluoropolymer.

2. The method as claimed in claim 1, wherein the vaccine composition is in liquid or lyophilized form.

3. The method as claimed in claim 2, wherein the fluoropolymer is selected from the group consisting of polytetrafluoroethylene (PTFE), polytetrafluoropropylene (PTFP), fluorinated ethylene propylene (FEP, a copolymer of hexafluoropropylene and tetrafluoroethylene), polychlorotrifluoroethylene (PCTFE), perfluoroalkoxy co-polymer (PFA), poly(ethylene-co-tetrafluoroethylene) (ETFE), poly(ethylenechlorotrifluoroethylene) (ECTFE), polyvinyl fluoride (PVF) and polyvinylidene fluoride (PVPF).

4. The method as claimed in claim 3, wherein the container is the reservoir of a syringe and the device acting as a stopper is a plunger.

5. The method as claimed in claim 4, wherein the inner surface of the container is coated with polymerized silicone.

8. The method as claimed in claim 1, wherein the antigen contained in the composition is hepatitis B surface antigen and the aluminum adjuvant is aluminum oxy hydroxide.

6. A method for storing a vaccine composition containing an antigen adsorbed on an aluminum adjuvant, the method comprising loading the composition into a container wherein the inner surface of the container is coated with polymerized silicone.

7. The method as claimed in claim 6, wherein the vaccine composition is in liquid or lyophilized form.

19. The method as claimed in claim 7, wherein the antigen contained in the composition is hepatitis B surface antigen and the aluminum adjuvant is aluminum oxy hydroxide.

9. A container for storing and/or administering a vaccine composition, wherein the container (i) contains a vaccine composition comprising an antigen adsorbed on an aluminum adjuvant and (ii) is closed by a device acting as a stopper, wherein the surface of the device contactable with the composition is coated with a fluoropolymer.

10. The container as claimed in claim 9, wherein the vaccine composition is in liquid or lyophilized form.

11. The container as claimed in claim 10, wherein the fluoropolymer is selected from the group consisting of polytetrafluoroethylene (PTFE), polytetrafluoropropylene (PTFP), fluorinated ethylene propylene (FEP, a copolymer of hexafluoropropylene and tetrafluoroethylene), polychlorotrifluoroethylene (PCTFE), perfluoroalkoxy co-polymer (PFA), poly(ethylene-co-tetrafluoroethylene) (ETFE), poly(ethylenechlorotrifluoroethylene) (ECTFE), polyvinyl fluoride (PVF) and polyvinylidene fluoride (PVPF).

18. The container as claimed in claim 11, wherein the antigen contained in the composition is hepatitis B surface antigen and the aluminum adjuvant is aluminum oxy hydroxide.

12. A container for storing and/or administering a vaccine composition, wherein the container (i) has inner surfaces coated with polymerized silicone and (ii) contains a vaccine composition comprising an antigen adsorbed on an aluminum adjuvant.

13. The container as claimed in claim 12, wherein the vaccine composition is in liquid or lyophilized form.

17. The container as claimed in claim 13, wherein the container is the reservoir of a syringe that is closed by a plunger.

21. The container as claimed in claim 13, wherein the antigen contained in the composition is hepatitis B surface antigen and the aluminum adjuvant is aluminum oxy hydroxide.

14. A container for storing and/or administering a vaccine composition, wherein the container (i) has inner surfaces coated with polymerized silicone;

(ii) contains a vaccine composition comprising an antigen adsorbed on an aluminum adjuvant; and

(iii) which is closed by a device acting as a stopper, wherein the surface of the device contactable with the composition is coated with a fluoropolymer.

15. The container as claimed in claim 14, wherein the vaccine composition, is in liquid or lyophilized form.

16. The container as claimed in claim 15, wherein the fluoropolymer is selected from the group consisting of polytetrafluoroethylene (PTFE), polytetrafluoropropylene (PTFP), fluorinated ethylene propylene (FEP, a copolymer of hexafluoropropylene and tetrafluoroethylene), polychlorotrifluoroethylene (PCTFE), perfluoroalkoxy co-polymer (PFA), poly(ethylene-co-tetrafluoroethylene) (ETFE), poly(ethylenechlorotrifluoroethylene) (ECTFE), polyvinyl fluoride (PVF) and polyvinylidene fluoride (PVPF).

20. The container as claimed in claim 16, wherein the container is the reservoir of a syringe that is closed by a plunger.

22. The container as claimed in claim 16, wherein the antigen contained in the composition is hepatitis B surface antigen and the aluminum adjuvant is aluminum oxy hydroxide.