47 results about "Hepatitis A 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 method for preparing a freeze-dried live attenuated hepatitis A vaccine by utilizing a cell factory. The method has good process controllability, is uneasy to pollute enviroment, is suitable for industrialized and mass production, improves the utilization rate of a culture space by more than 3 times, ensures that the growth density of cells reaches between 4.0x10<6> and 5.0x10<6> cells per ml, assures the multiplication space of viruses, and also effectively solves the problem of cell residue after the cell factory digests through methods such as sterile washing, centrifugal treatment and so on, so as to continuously use the cell factory for cell culture and improve the reuse rate of the cell factory.

The invention relates to a freeze-dried live attenuated hepatitis A vaccine and its preparation, which comprises live attenuated hepatitis A vaccine virus liquid and freeze-drying protective agent by the volumetric ratio of 1:0.7-1.2, and the freeze-drying protective agent comprises the following constituents: trehalose 2-10%, gelatin 0.1-1%, dextroglucose glycoside 0.5-1.5%, glycine 0.5-1.5%.

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 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.

The invention discloses a hepatitis A virus strain HAV-ZL2012, a vaccine prepared by using same and application thereof. According to the invention, through the adoption of a reverse molecular biology technology and a novel subculturing method, the adaption and attenuation of a virus strain obtained through primary isolation are realized and rapidly facilitated; and growth, immunity and safety studies show that the virus strain HAV-ZL2012 can be used for preparing both live attenuated vaccines and inactivated vaccines. According to the invention, through the adoption of a rapid attenuation and adaption method of the hepatitis A virus, the growth period of the hepatitis A virus is reduced from 100 days to 14 days. The generation order of subculture adaption on a diploid cell is reduced from 40 generations to 10 generations; the generation order of subculture adaption on a subculture cell is reduced to 10-15 generations; the production period and cost are greatly reduced; and a great promoting effect on the development of a hepatitis A vaccine is obtained.

The invention discloses a fusion protein of antibody Hepatitis B vaccine belonging to the bio-engineering field. It has two functional domains which composed of preS2 of Hepatitis B surface antigen in N-terminal and S protein, and IgG1 Fc in rats. The invention also discloses the vector containing the gene coding the said fusion protein. The invention also discloses a antibody Hepatitis B vaccine. The constructed antibody Hepatitis B vaccine may induce a strong humoral-mediated immune response and a cell-mediated immune response which has a better effect than the traditional vaccine.

The invention relates to the field of biotechnology, in particular to a production method for a hepatitis A virus for vaccine production. The production method comprises the following steps sequentially: reviving, passaging and amplifying a cell; vaccinating a hepatitis A virus seed; keeping culturing the cell infected with hepatitis A virus; detecting the reproduction condition of viral infection; stopping culturing, discarding the maintenance medium, and reaping the cultured infected cell; collecting cell suspension; and extracting and purifying the cell suspension. The production method has the advantages that the operation is simple; the production intensity is low; the high-density large-scale cultivation of stromal cells is realized; the yield and the quality stability of hepatitis A vaccine are improved; and pollution caused by manual operation in the conventional manufacturing technology is avoided.

The invention discloses a technology for preparing HBsAg through expression by virtue of recombinant saccharymyces cerevisiae and a separation and purification technology of the HBsAg. The separation and purification technology of the HBsAg comprises the following steps: breaking cells, namely feeding cerevisiae cells extracted after fermentation into a high pressure homogenizer and breaking the cerevisiae cells at a pressure of 15000+ / -1500PSIG; heating feed liquid after breaking, namely heating the feed liquid to 50-80 DEG C and then cooling the feed liquid to 2-8 DEG C; and purifying, namely purifying the feed liquid and preparing HBsAg raw liquid. The invention also discloses a corresponding hepatitis B vaccine and HBsAg. The technology for preparing the HBsAg through expression by virtue of the recombinant saccharymyces cerevisiae has the advantages that protease can be inactivated without adding a protease inhibitor before the cells are broken, so that secondary pollution caused by the protease inhibitor is avoided; meanwhile, the yield of the raw liquid obtained through purification subsequently can be obviously increased, and quality indexes such as 'specific activity' and 'Sub-p24' of the raw liquid are greatly improved, so that the technology for preparing the HBsAg through expression by virtue of the recombinant saccharymyces cerevisiae has high economic benefit and social benefit.

The invention discloses a method for culturing a chicken pox-herpes zoster vaccine virus with a high-level human diploid cell. The method comprises the steps of establishing a main cell bank: taking an ATCC (American Type Culture Collection) (CCL171) cell strains at a 17th generation at the beginning according to United States FDA (Food and Drug Administration) standards, subculturing for totally 3-5 times in approximately 20 days, storing collected cells in liquid nitrogen with a cryovial, conducting working cell bank cell culture, horizontally synchronously monitoring diploid cell population doubling, and producing a vaccine with the cell strains having diploid cell population doubling levels above 2.5. With the adoption of the method, the yield of the attenuated chicken pox-herpes zoster virus vaccine is higher, and the method facilitates large-scale preparation of the herpes zoster vaccine and is applicable to scale production. The method can be used for industrial production of other live vaccines such as a hepatitis A vaccine, a rabies vaccine, a measles vaccine and a smallpox vaccine.

The present invention provides one kind of fast and sensitive method for detecting virus infection titer of attenuated live hepatitis A vaccine. The method determines the existence of the virus via detecting the negative brand RNA intermediate of marker appearing during duplicating hepatitis A virus, and is superior to available inverse transcription PCR method and cell culturing method. The method has culture period shortened to 8 days, short detection period, no need of replacing maintaining liquid, less contamination possibility, less cell post-treating steps, high work efficiency and capacity of providing virus heredity information via sequencing the PCR product.

The invention provides a testing method of in vitro relative efficiency of inactivated hepatitis A vaccine. The traditional mouse in vivo relative efficiency testing method is thoroughly replaced, the negative factors of more influential factors, poor repeatability and 30 days of testing period which are caused by using animals are solved, the testing can be accomplished in only 3.5 hours, the vaccine storage is reduced, the effective period of the vaccine is indirectly prolonged, the labor intensity is reduced, 1,5 million to 2 million vaccines can be additionally produced when vaccine is insufficient particularly, and 45 million to 60 million production value can be output. In addition, the method adopts the double-parallel line biological assay principle, provides a testing method of in vitro relative efficiency of inactivated hepatitis A vaccine, and ensures that good linear regression is presented between HAV viral content and the logarithm corresponding to A value, and R is over 0.97; and the testing result demonstrates good stability and repeatability, therefore, the testing method is convenient, quick and reliable.

The invention discloses a new utility of hepatitis B surface antigen-antibody compound in the hepatitis B vaccine non-respond or low-respond prevention agent, which is characterized by the following: purifying recombined HBsAG or inactivated serum HBsAG in the mammal cell, adopting hepatitis B with antibody serum or vaccine globulin as compound, improving anti-HBs ability for non-respond or low-respond mouse.