Drug – bio-affecting and body treating compositions – Nonspecific immunoeffector – per se ; or nonspecific... – Lipid or oil
Reexamination Certificate
2001-10-09
2003-12-30
Housel, James (Department: 1648)
Drug, bio-affecting and body treating compositions
Nonspecific immunoeffector, per se ; or nonspecific...
Lipid or oil
C424S184100, C424S204100, C424S278100
Reexamination Certificate
active
06669947
ABSTRACT:
CROSS REFERENCE TO RELATED APPLICATION
The present application claims the benefit under 35 U.S.C. §119 of French application 00/12817 filed Oct. 6, 2000, the disclosure of which is hereby incorporated by reference.
BACKGROUND OF THE INVENTION
(i) Field of the Invention
The present invention relates to a novel vaccine formulation comprising at least one antigen, in particular an antigen of viral, bacterial or parasitic origin, and the method for its preparation.
Currently, the customary vaccines have a storage life which does not exceed 18 to 24 months at +4° C., whether they are oil-based or aqueous. Trials carried out by the Institute for Animal Health (IAH) in Great Britain have shown that oil-based vaccines frozen at −20° C. and at −70° C. lost their activity. Accordingly, commercial vaccines are labeled in this country with the label: “not to be frozen.”
Antigens may be stored for longer periods, up to 15 years, at very low temperature, in the form of concentrates. It is essential, in this case, to have means for formulating vaccines close to their storage site in order to avoid loss of time when the vaccine is urgently required.
These considerations have led the applicant to support work aimed at developing vaccines which can be stored for several years, and which are ready to use after thawing.
SUMMARY OF THE INVENTION
According to a first aspect, the subject of the invention is a composition comprising at least one antigenic medium and at least one adjuvant, characterized in that:
(a) the antigenic medium or the antigenic media constitute phases which are distinct from the adjuvant phase or from the adjuvant phases when the composition is in the solid state, and
(b) the composition is in the liquid state when its temperature is greater than or equal to 4° C.
The expression distinct phases indicates that, in the composition which is the subject of the present invention, none of the phases is, in the solid state, included, dissolved, emulsified or dispersed in another.
REFERENCES:
patent: 3269905 (1966-08-01), Damaskus
patent: 5424067 (1995-06-01), Brancq et al.
patent: 6117432 (2000-09-01), Ganne et al.
patent: 6251407 (2001-06-01), Ganne
patent: WO 91/00106 (1991-01-01), None
patent: WO 96/32964 (1996-10-01), None
patent: WO 98/17311 (1998-04-01), None
patent: WO 00/03744 (2000-01-01), None
French-International Search Report dated Jul. 23, 2001, International application No. FA 594203, FR 0012817.
Aucouturier Jerome
Barnett Paul
Ganne Vincent
Hill Myron G.
Housel James
Hunton & Williams
Societe d'Exploitation de Produits pour les Industries Chim
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