Fluid vaccines and active principle vehicles containing a metabo

Details Fluid vaccines and active principle vehicles containing a metabo Fluid vaccines and active principle vehicles containing a metabo

1992-02-28

1995-06-06

Nucker, Christine M.

Drug, bio-affecting and body treating compositions

Antigen, epitope, or other immunospecific immunoeffector

4242781, 4242831, 514785, A61K 3939, A61K 9113

Patent

active

054221099

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to novel compositions of fluid vaccines and injectable substances, containing a totally or partially metabolizable oily phase, which can be used in veterinary or human medicine.
Vaccination is a means of combating infections by prevention, the aim of which is to alert the immune defense system by the injection of antigens, which are often very specific fractions of the viral or bacterial walls.
Advances in genetic engineering are such that the antigens available are more and more pure or even totally synthetic. Although this purity is an undeniable asset from the point of view of the safety of the vaccine, it is generally accompanied by a decrease in the immunological efficacy.
There is therefore an ever-increasing demand for immunity adjuvants making it possible to enhance the responses of the immune system to an antigen. However, the presence of these adjuvants must not compromise the high safety of modern antigen preparations.
A very large number of immunity adjuvants have been described, but only a few of them are used at the industrial vaccine stage and only aluminum hydroxide and phosphate are authorized in human medicine.
It is nevertheless acknowledged that "oily" vaccines, in which the antigen medium is emulsified with a mineral oil containing an emulsifier, are the most effective, especially when these vaccines are of the W/O type.
The adjuvant resulting from the association of mineral oil with a mannitol ester is known as Freund's incomplete adjuvant (FIA) in the literature; it has the following composition:


______________________________________ fluid mineral oil (Bayol F type): 85% mannide monooleate (Arlacel A): 15% ______________________________________
The difference between FIA and FCA, Freund's "complete" adjuvant, is that the latter contains, in addition to the above-mentioned components, a tuberculin mycobacterium which potentiates the immune effect.
These adjuvants FIA and FCA, which have been known for a long time, are still the reference products for laboratory immunology studies throughout the world.
In particular, they are found associated with novel injectable adjuvants, such as the muramyl dipeptides (MDP), or antigens obtained by chemical or genetic synthesis (VP1, etc.).
The industrial use of vaccines containing FIA and FCA is limited, however, because of the difficulty of using them in injectable vaccine preparations and their poor tolerance by the subjects vaccinated therewith.
In fact, it is known that oily emulsions obtained from FIA and FCA are viscous, like mayonnaise, and release oil. Consequently, these preparations are difficult to inject by means of syringes with a needle of small diameter (0.2 mm).
Furthermore, at the site of injection into animals, they create local reactions with edemas and abscesses, which are not acceptable to the Health Authorities, making the animal unsuitable for human consumption.
Diphtheria vaccine preparations made with FCA have even caused serious intolerances and abortion syndromes when injected into women, which have prohibited the general use of these adjuvants in humans.
An Example of a foot-and-mouth disease vaccine containing FIA is described below in order to demonstrate the immunological efficacy, the physicochemical properties and the poor tolerance of this type of preparation.


EXAMPLE 1

A vaccine preparation for the treatment of foot-and-mouth disease in cattle is made from Freund's incomplete adjuvant (FIA) by mixing one part of FIA and one part of inactivated antigen medium, with mechanical agitation.
The antigen medium was prepared with particular care during the culture, purification and concentration of the antigens, which are diluted in an Eagle-type medium in the presence of phosphate buffer.
The preparation therefore has the following composition (weight/weight):


______________________________________ Antigen medium 50% Mineral oil 42.5% Mannide monooleate 7.5% ______________________________________
The physicochemical characteristics obtained for this preparation are

REFERENCES:
patent: 3983228 (1976-09-01), Woodhour et al.
patent: 4069313 (1978-01-01), Woodhour et al.
patent: 4795635 (1989-01-01), Peleg et al.
patent: 4803070 (1989-02-01), Cantrell et al.
Michalek et al (1983) Abstract Only Mol Immunol 20(9):1009-1018.
Yamamoto et al (1978) Abstract Only, Jpn J Med Sci Biol 31(3):263-276.
Yamamoto et al (1978) Abstract Only Jpn J Med Sci Biol 31(56):393-406.
Barteling (Sep. 1980) Abstract Only Tijdschr Diergeneeskd 105(17):695-698.
Francis et al (1983) Abstract Only J Hyg 91(2):329-334.
Al-Dabbass et al., "Immunizing Activity of Oil Adjuvant Attenuated Spore Vaccine of Bacillus anthracis in Sheep", J. Vet. Med. B 33, 340-345 (1986).
Woodard, L., "Adjuvant Activity of Water-Insoluble Surfactants", Lab. Animal Sci., vol. 39, No. 3, pp. 222-225 (1989).

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