12 results about "Hb vaccine" patented technology

This invention discloses a biological agent for enhancing the immune response to hepatitis B vaccine using *Bifidobacterium adolescentis*, comprising: a preparation of *Bifidobacterium adolescentis* and a hepatitis B vaccine. The *Bifidobacterium adolescentis* preparation is a live *Bifidobacterium adolescentis* capsule. The live *Bifidobacterium adolescentis* capsule uses *Bifidobacterium adolescentis* live capsules from Lizhu Chang Le. The hepatitis B vaccine is a recombinant yeast hepatitis B vaccine. The recombinant yeast hepatitis B vaccine uses a recombinant hepatitis B vaccine from *Saccharomyces cerevisiae*. In high-responder populations receiving hepatitis B vaccine booster vaccination, the intestinal flora is rich in *Bifidobacterium adolescentis* 8 weeks post-vaccination. KEGG function analysis indicates that the intestinal flora function of high-responder populations is stronger than that of low / non-responder populations to hepatitis B vaccine. Bifidobacterium is positively correlated with various metabolic functions. Oral administration of *Bifidobacterium adolescentis* can enhance the immune response to hepatitis B vaccine.

The present invention relates to antibodies and antigen-binding fragments thereof directed against hepatitis B virus surface antigen (HBsAg), and methods of making and using the neutralizing antibodies and antigen-binding fragments thereof. The antibody provided by the invention is derived from a hepatitis B vaccinator and a hepatitis B infection convalescent person, shows an excellent effect in the aspect of identifying different hepatitis B virus surface antigens, and has more advantages in the aspects of neutralizing hepatitis B virus mutants and reducing hepatitis B mutant antigens.

The invention relates to a tunable Raman spectrum-based recombinant hepatitis B vaccine stock solution identification method and a process quality control method. On the basis of a tunable Raman spectrum measurement system, multi-dimensional Raman spectrum information of a recombinant hepatitis B vaccine stock solution sample to be detected under different concentration disturbance conditions is tested, spectral characteristics are extracted from a high-dimensional spectrum, and characteristics of recombinant hepatitis B vaccine target protein HBsAg are represented through common peaks and specific peaks in two-dimensional correlation analysis. And the secondary structure of the target protein HBsAg of the recombinant hepatitis B vaccine can be identified or structural characterization and analysis can be further realized on the basis of spectral data. By means of the characterization method, the recombinant hepatitis B vaccine stock solutions of different production matrixes can be characterized and identified, and process quality control and evaluation of the recombinant hepatitis B vaccine stock solutions can be further achieved.

The present invention relates to immunotherapy for hepatitis B and other infectious diseases, including immune cell therapy and immune factor therapy, and the application of vaccine development research. Specifically, it relates to the technical fields of induction templates, induction methods, and cell therapy for infectious diseases, tumors and other diseases, immunotherapy and vaccine development, and discloses a method for activating the antibody secretion effect of hepatitis B antibody-positive B cells on hepatitis B vaccine, including the following steps: 1) Animal grouping and dosage: Experimental animal grouping method: Female and male animals are stratified and randomly grouped according to body weight, and are divided into 3 groups: 4 positive control groups, 4 low-dose cell therapy groups, and 2 high-dose cell therapy groups, half male and half female. The method for stimulating the antibody secretion effect of hepatitis B antibody-positive B cells on hepatitis B vaccine does not use viral vector gene transcription or other vector gene editing technology methods, but has the effect of activating antibody-secreting B cells.

The invention relates to a multi-HBV immunogen viral vector vaccine comprising: a viral vector comprising an immunogen expression cassette, wherein the expression of a protein encoded by the expression cassette is arranged to be driven by a promoter, wherein the immunogen expression cassette encodes: a) HBV Core; b) a modified HBV polymerase (Pmut), wherein the modification is a mutation to wild-type HBV polymerase to substantially remove polymerase function; c) HBV surface antigen (HbsAg); and d) an intergenic sequence that is arranged to cause expression of at least the HBV surface antigen (HbsAg) as a separate protein from the HBV core and the modified HBV polymerase (Pmut), wherein the intergenic sequence is downstream (3′) of the sequences encoding the HBV core and the modified HBV polymerase (Pmut) and upstream (5′) of the sequence encoding the HBV surface antigen (HbsAg); and related compositions, vaccination methods and methods of treatment or prophylaxis of HBV infection.

The invention is suitable for the technical field of biological cells, and provides a preparation method and application of a hepatitis B vaccine adjuvant containing a GV657-ALKBH5 mixture. According to the invention, the GV657 plasmid carrying ALKBH5 is transfected into the dendritic cells, so that the antigen presentation phenotype of the dendritic cells can be effectively improved, and the activation of CD4 + T cells is promoted; the plasmid and the hepatitis B vaccine are sequentially added into the dendritic cell, so that the immune response of the dendritic cell to the hepatitis B vaccine can be effectively improved, and the dendritic cell is added into a CD4 + T cell, so that the activation of the CD4 + T cell can be effectively induced; in the environment of giving HBV stimulation in advance, the GV657-ALKBH5 can obviously improve the immune response of dendritic cells and CD4 + T cells to the hepatitis B vaccine.

The invention discloses a preparation method of a biological agent for enhancing immune response of an infant hepatitis B vaccine generated by an HBsAg positive mother based on a dendritic cell exosome. The preparation method comprises the following steps: obtaining the dendritic cell exosome; preparing a Dex + HepB biological preparation; establishing an HBV intrauterine exposure animal model; and the Dex + HepB biological agent is used for intervening in HBV intrauterine exposed animals. In application verification, an HBV intrauterine exposure mouse model is constructed to simulate the immune state of an infant born by an HBsAg positive mother. And then, according to an immune procedure of 0-2-4 weeks, injecting the prepared Dex + HepB biological agent into the body of a model mouse. Experimental results show that the preparation can effectively improve the proportion of CD4T cells in the spleen of a mouse, improve the expression level of Th2 type cytokines and remarkably enhance the generation of anti-HBs, so that the immune response of the mouse to hepatitis B vaccines is comprehensively improved.

The invention discloses an oral hepatitis B vaccine and a preparation method thereof. The preparation method comprises the following steps: preparing a milk exosome; construction and purification of hepatitis B surface antigen; and encapsulating the purified hepatitis B surface antigen into the milk exosome by adopting a membrane fusion method to obtain the oral hepatitis B vaccine. In the preparation method of the oral hepatitis B vaccine provided by the invention, the exosome is extracted and separated from fresh milk through a mechanical separation method and sucrose density gradient centrifugation and is used as an oral drug delivery carrier; secondly, inserting the hepatitis B virus surface antigen gene into engineered yeast, and expressing hepatitis B virus surface antigen protein; subsequently, mixing the purified hepatitis B surface antigen with cationic liposome, encapsulating the hepatitis B surface antigen into exosome by using a membrane fusion method, and carrying out characterization and activity test to obtain the oral hepatitis B vaccine. The oral hepatitis B vaccine prepared by the preparation method of the oral hepatitis B vaccine provided by the invention can tolerate the gastrointestinal tract environment in the body of an experimental mouse, can penetrate through the intestinal epithelial barrier, and finally stimulates the body to generate a hepatitis B antibody.

The invention relates to the technical field of hepatitis B vaccine production, and discloses a hepatitis B vaccine production whole process quality monitoring and early warning system, which comprises the following modules and components: a system initialization and basic construction module, a production whole link quality monitoring module, and a system dynamic optimization and upgrade module. The system initialization and basic construction module comprises a supplier qualification auditing terminal, a sensor cluster, RFID read-write equipment, an early warning terminal, a raw material quality standard database, a supplier basic archive library, a supplier rating subsystem, an LSTM process prediction model training platform, a parameter threshold setting terminal and an early warning level setting unit; the production whole-link quality monitoring module comprises a raw material purchase admission control sub-module, an engineering bacterium fermentation real-time monitoring sub-module, a purification and inactivation precise control sub-module and a stock solution and semi-finished product quality comprehensive evaluation and early warning sub-module; the objective of the invention is to solve the problem that the instantaneity and comprehensiveness are seriously insufficient.

The present invention relates to an antibody against a hepatitis B surface antigen (HBsAg) and an antigen-binding fragment thereof, and methods for preparing and using the antibody and the antigen-binding fragment thereof. The present invention further relates to bispecific antibodies that specifically bind to different epitopes on HBsAg. The antibodies are derived from persons inoculated with hepatitis B vaccines and persons having recovered from hepatitis B infections, show superior effects in recognizing different hepatitis B surface antigens, and have greater advantages in neutralizing hepatitis B virus mutants and reducing hepatitis B mutant antigens.

The present disclosure relates to a method for evaluating the quality of the production process of a recombinant hepatitis B vaccine. The evaluation of the production process quality includes the quality evaluation of the recombinant hepatitis B vaccine bulk solution and the evaluation of the between-batch consistency of the recombinant hepatitis B vaccine bulk solution. The evaluation method comprises the following steps: (1) enriching the vaccine bulk solution to be tested, preparing an infrared detection sample for infrared spectroscopy detection; (2) analyzing and calculating the infrared spectrum of the vaccine bulk solution to be tested obtained by using the established quality evaluation model of the recombinant hepatitis B vaccine bulk solution to obtain multiple matching values, and then comparing the matching values with the quality evaluation criteria, and realizing the quality evaluation of the vaccine bulk solution to be tested through the comparison result; (3) evaluating the between-batch consistency of the vaccine bulk solution to be tested by using the consistency evaluation model. The evaluation method provided by the present disclosure can realize the quality evaluation of the intermediate product for preparing the recombinant hepatitis B vaccine, and can also evaluate the between-batch consistency of the vaccine bulk solution.