TH83243B - Methods of manufacturing combination vaccines. - Google Patents

Abstract

DC60 (03/02/53) This invention relates to a method for producing combination vaccines capable of providing simultaneous protection against several diseases, such as diphtheria, tetanus, pertussis, and hepatitis B, which should be prevented in newborns. The method for producing the combination vaccine according to this invention includes independent steps for the absorption of individual protective antigens to an aluminum hydroxide gel adsorbent for the various diseases, such as diphtheria, tetanus, pertussis, and hepatitis B, which should be prevented in newborns, and the incorporation of the absorption-absorbed protective antigens into each adsorbent after absorption. In this invention, it is possible to provide protection against multiple diseases, such as diphtheria, tetanus, pertussis, and hepatitis B, which should be prevented in newborns, using the combination vaccine produced according to this invention. This invention relates to a method for producing combination vaccines capable of providing simultaneous protection against several diseases, such as diphtheria, tetanus, pertussis, and hepatitis B, which should be prevented in newborns. The method for producing the combination vaccine according to this invention... This invention includes independent steps for the adsorption of individual protective antigens onto an aluminum hydroxide gel adsorbent for various diseases such as diphtheria, tetanus, pertussis, and hepatitis B that should be prevented in newborns, and the incorporation of the adsorbed protective antigens onto the individual adsorbents. Under this invention, it is possible to implement the prevention of multiple diseases such as diphtheria, tetanus, pertussis, and hepatitis B that should be prevented in newborns using co-administrator vaccines manufactured according to this invention.

Claims (13)

1. The method for producing co-administered vaccines consists of two steps: an adsorption step, where each protective antigen is independently adsorbed onto the adsorbent material according to the different diseases, and a combination step, where the adsorbed protective antigens are mixed together with the adsorbed adsorbent material. 2. Method of Claim 1, where the preventive antigen is an antigen selected from a group comprising diphtheria antigen, tetanus antigen, pertussis antigen, hepatitis B antigen, or two or more of them. 3. Method of Claim 1, where the adsorbent is aluminum hydroxide gel. 4. Method of Claim 3, where the concentration of aluminum ions in the aluminum hydroxide gel after vaccine production is in the range of 0.5 ~ 1.25 mg/ml. 5. The method of claim 3 or 4, which also includes the procedure of: adding an adsorbent with an aluminum ion concentration not exceeding the range of 0.5~1.25 mg/ml to an aluminum hydroxide gel. 6. Method of Claim 2, whereby recombinant hepatitis B surface antigens used as hepatitis B antigens are incorporated in an amount of 5–10 (mu)g, based on the dose given to children. 7. The method of claim 6, which also includes the following steps: Addition of a neutral surfactant such as polysorbate 20, polysorbate 80, and triton X-100. 8. Method of Claim 6, where the hepatitis B antigen is mixed by stirring with an adsorbent at 2~8°C for 3~20 hours and is ready for use and adsorbed. 9. Method of Claim 2: Diphtheria toxoids are neutralized, and diphtheria antigens are incorporated at a dose of 10~25 Lf, based on the dose administered to the child. 10. Method of Claim 2, whereby tetanus toxoids are neutralized to form diphtheria antigens, and the dose is incorporated at a rate of 1-5 Lf based on the dose administered to children. 11. Method of Claim 2 whereby pertussis antigens, including purified antigens, are incorporated at doses less than 20 (mu)gPN based on the dose administered to the child, or whole pertussis cell antigens are incorporated at doses less than 20OE based on the dose administered to the child. 12. Method of Claim 2, whereby the purified pertussis antigens referred to include pertussis toxoids and pertussis FHA (philamentus hemiagglutinin). 13. Co-operative vaccines produced pursuant to any one of the claims in Claims 1 through 12.