Stabilizing agents for live viruses for preparing vaccines, and

Drug – bio-affecting and body treating compositions – Lymphokine

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A61K 39275

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active

045005125

ABSTRACT:
The stabilizing agent is constituted by a phosphate buffer solution (PBS) containing calcium and magnesium ions, which contains in addition lactose, sorbitol and at least one amino acid taken from the group which comprises histidine, alanine, valine, threonine, arginine, methionine, hydroxyproline, lysine, isoleucine, phenylalanine, serine, and preferably constituted by an association of histidine and alanine. The stabilized vaccine is constituted by a suspension of live attenuated viruses in the above stabilizing agent, and lyophilized. The invention also relates to the method for preparing such a stabilized vaccine, to the stabilized vaccines so-obtained and to their use for treating viral diseases in humans or animals.

REFERENCES:
patent: 3686394 (1972-08-01), Huygelen
patent: 3873421 (1975-03-01), Chagnon
Robin et al., Bull. WHO 44:729-737 (1971)(FR), Study of the Heat Stability of Anti-yellow Fever Vaccine in Samples of Eight Batches from Various Countries.
Finter et al., Dev. Biol. Stand. 36:279-283 (1977), Long Term Storage Studies with a New Stabilized Formulation of Yellow Fever Virus Vaccine.
Finter et al., Dev. Biol. Stand. 41:271-276 (1978), Effects of Adverse Storage on Live Virus Vaccines.
Burfoot et al., J. Biol. Stand. 5:173-179 (1977), The Thermal Stability of a Stabilized 17-D Yellow Fever Vaccine, ("Arilvax", Wellcome Fnon, Ltd.).
Lucasse et al., J. Biol. Stand. 6:1-11 (1978), Influence of Various Temperatures in Relation to Time on 17-D Yellow Fever Virus Vaccines.
Tannock et al., J. Biol. Stand. 8:23-34 (1980), The Development of an Improved Experimental Yellow Fever Vaccine (Stabilized Protein-Free).
Moss-Blundell et al., J. Biol. Stand. 9:445-452 (1981), A Clinical Study of Stabilized 17-D Strain Live Attenuated Yellow Fever Vaccine (Arilvax, Wellcome).
Peetermans, J., "Stability of Freeze-dried and Reconstituted Measles Vaccines", Develop. Biol. Standards, vol. 41, pp. 259-264, (1978).
McAleer, W. J. et al., "Stability on Storage at Various Temperatures of Live Measles, Mumps and Rubella Virus Vaccines in New Stabilizer", Journal of Biological Standardization, 8, 281-287 (1980).
Finter, N. B., et al., "Long Term Storage Studies with a New Stabilized Formulation of Yellow Fever Virus Vaccine", Develop. Biol. Standard, vol. 36, pp. 279-283 (1977).

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