127 results about "Hepatitis B virus vaccine" patented technology

The invention provides a recombinant DNA sequence, hansenula polymorpha, a preparation method for hepatitis B surface antigen, and a hepatitis B vaccine. The recombinant DNA sequence is obtained by codon optimization of coding genes of the hepatitis B virus surface antigen according to codon usage frequency of the hansenula polymorpha. The invention also provides the hansenula polymorpha comprising the recombinant DNA sequence, a method for preparing adr sub-type hepatitis B surface antigen by using the recombinant DNA sequence, and the hepatitis B vaccine. The adr sub-type hepatitis B surface antigen has high expression level of the recombinant DNA sequence. The recombinant hansenula polymorpha is fast in growth speed, has high HBsAg yield, can be fermented in high cell density by using a cheap chemically synthetic medium, has low fermentation contamination rate and is beneficial to large-scale production; and HBsAg adr vaccine provided by the invention has high trend of Th1 and Th2 type cellullar immunologic response.

The invention discloses a preparation method of an aluminum-containing adjuvant hepatitis B vaccine, belonging to the biotechnology field. The preparation method is characterized in that an aluminum adjuvant Al(OH)3 is produced by an on-line reaction, i.e. after a phosphate buffer solution (PBS), a KAl(SO4)2 solution and a hepatitis B surface antigen stock solution are mixed, an NaOH solution is added to the mixed solution, an Al(OH)3 adjuvant is continuously produced, and simultaneously, hepatitis B surface antigens are continuously coated and adsorbed; and the process is called 'in-situ adsorption'. In the invention, the Al(OH)3 adjuvant is produced by an in-situ reaction to greatly improve the adsorption rate of the hepatitis B surface antigens, thereby improving the immunogenicity of the antigens, being capable of more effectively causing organisms to generate an immune response, and producing more protective antibodies. The practice proves that the aluminum adjuvant hepatitis B vaccine produced by the method disclosed by the invention has the advantages of small inoculation amount, few adverse responses, high antibody positive conversion rate and the like, and can induce high-level antibody response after being immunized. Simultaneously, the processing steps are also simplified, and the production cost is greatly lowered.

The invention relates to a hepatitis B vaccine preparation method using an aluminium phosphate adjuvant in-situ method. The hepatitis B vaccine preparation method comprises the following steps: 1) sequentially adding an aluminum chloride solution, water, a sodium chloride solution and hepatitis B surface antigen stoste into a reactor for stirring and mixing; 2) adding a mixing solution of disodium hydrogen phosphate and sodium hydroxide for stirring. The vaccine prepared through the method is a polydispersity system with a grain diameter about 45 nm, the grains of the vaccine are uniform, fine and smooth, and the vaccine has excellent intracorporal and extracorporeal relative potencies and high stability. The hepatitis B vaccine preparation method is short in production cycle, simple in technological operation and low in manufacturing cost, and facilitates large-scale production.

The present invention relates to a hepatitis B vaccine, the main composition of said vaccine comprises gene engineering hepatitis B virus surface antigen, muramyl dipeptide (MDP) and aluminium adjuvant. Said hepatitis B vaccine can be used for immunity of adult, renal transplanted patient and patient with renal dialysis therapy and for preventing infection of hepatitis B virus, and said hepatitis B vaccine also can be used for immunotherapy of chronic hepatitis B patient, and the immunogenicity of said vaccine is superior to that of existent aluminium adjuvant hepatitis B vaccine.

The therapeutic hepatitis B vaccine is liposome containing hepatitis B surface antigen with or without immunoregulation molecule. It may be used to treat chronic hepatitis B caused by HIV infection and to prevent HIV infection. The technological process of inverse phase evaporation and freeze drying to prepare the said vaccine is also provided.

The invention discloses a production method of a recombinant saccharomyces-fermentum-expressed hepatitis B surface antigen. The method comprises the steps of: circularly removing triton from an extracted antigen by using XAD-4 column, so as to obtain triton-removed antigen sample liquid; loading macroporous silica gel with the pore size of 1,000 A and the particle size of 35-70 microns into a chromatographic column, and balancing by using phosphoric acid buffer solution with the pH of 7.6+ / -0.2; adjusting the pH of the triton-removed antigen sample liquid to be 7.6+ / -0.2 by using NaOH, then, loading a sample to the macroporous silica gel column; and cleaning impurities by using phosphoric acid buffer solution with the pH of 7.2+ / -0.2, carrying out eluting treatment on the impurity-cleaned macroporous silica gel column by using boric acid buffer solution with the pH of 8.7+ / -0.2 at the temperature of 47-49 DEG C, collecting eluate, and carrying out ultrafiltration and concentration on the eluate, thereby obtaining a clarified antigen. The invention further discloses the corresponding recombinant saccharomyces-fermentum-expressed hepatitis B surface antigen, a hepatitis B vaccine and a production method of the hepatitis B vaccine. The production methods have the advantages that the probability of product contamination is reduced greatly, the labor intensity for laborers is reduced, the equipment investment and repairing cost are reduced, the space occupied by equipment is reduced, and the production time is shortened.