Mechanism The complete eradication of Hepatitis B Virus (HBV) infection is ultimately through the action of the body’s immune system, but HBV can inhibit the body’s specific immune response through a series of mechanisms after it infects the human body. Therefore, research is needed to elucidate the immune escape mechanism of HBV and develop novel immunotherapy to further improve the efficacy and reduce the disease mortality rate. Many organizations at home and abroad are doing research on therapeutic hepatitis B vaccine. In recent years, China has made some progress in research, and there are now four therapeutic hepatitis B vaccines from three research institutions that have entered clinical trials. Classification At present, therapeutic hepatitis B vaccines are mainly divided into genetically engineered protein vaccines, DNA vaccines, DC vaccines and so on. Genetically engineered protein vaccines are divided into: 1, subunit vaccines Subunit protein vaccines used for the treatment of chronic hepatitis B are recombinant HBsAg produced by genetic engineering methods, which contain different components of HBV envelope proteins (preS1, preS2, S) and are expressed through mammalian cells and yeast systems. Treatment of chronic hepatitis B with such vaccines has been based mainly on routine doses of prophylactic vaccines with increased immunization, and the results, although suggestive of some therapeutic effect, have been only temporary. The results suggest that the existing vaccine needs to be improved to enhance the ability to induce specific cellular immune response. 2, immune complex-type vaccine Fudan University School of Medicine, Wen Yumei et al. constructed HBsAg plus human anti-HBS immunoglobulin as an immunogenic complex-type therapeutic vaccine, this vaccine is to change the way of presentation of HBsAg in order to induce effective immunity and eliminate immune tolerance. The antibody enhances the immunogenicity of the antigen by increasing the capture and processing of the antigen by APC cells, which in turn activates antigen-specific lymphocytes and induces an immune response. The immune-complex-type vaccine produced anti-HBs antibodies in HBsAg transgenic mice, and also cleared HBsAg from some HBsAg transgenic mice and produced anti-HBs antibodies. For 14 cases of slow hepatitis B patients with HBV replication, 9 cases (64.3%) were negative for serum HBV DNA and 6 cases (42.9%) were negative for HBeAg. 3, peptide vaccine As the protein antigen is finally processed into epitope peptide by APC cells, after combining with MHC molecules, it is recognized by specific T cells and stimulates immune response. Therefore, the study of effective antigenic molecular epitopes has been a research trend in recent years. In the treatment of patients with chronic hepatitis B, it was found that the CTL response generated in vivo was significantly lower than that induced in normal subjects. There was no effect on virologic symptoms and HBeAg seroconversion in carriers. The reason may be due to the decreased secretion of Th1-like cytokines IFN-γ and IL-2 and the imbalance of Th1/Th2-like cytokines in chronic hepatitis B patients. And it has strict HLA-A2 restriction and limited application. Three major categories (I) Protein vaccine Protein vaccine is the most intensively studied therapeutic hepatitis B vaccine, and its main principle is to vaccinate patients with certain modifications of hepatitis B virus (HBV) coat proteins (e.g., preS1, preS2, S) or core antigen (HBcAg). Since both HBV coat protein and core antigen are highly antigenic, they induce strong specific cellular immunity. (ii)Gene vaccine The DNA of HbsAg (Hepatitis B surface antigen) is loaded onto a plasmid, which can re-synthesize the antigen in the vaccinated patient, eliminating the risk of injection and reversal, and repeatedly stimulate the immunologically active cells to produce humoral and cellular immunity with the same effect as the attenuated vaccine. (iii) Cellular vaccines DCs loaded with HBV-related antigens may be effective in breaking immune tolerance, restoring cellular immune response and clearing HBV. Regarding therapeutic Hepatitis B vaccine, experts said that therapeutic Hepatitis B vaccine entering Phase III clinic is within the scope of the administration of the FDA. The State Food and Drug Administration will approve it according to national laws and regulations. About Therapeutic Hepatitis B Vaccine. With the progress of medical science, the vaccine is only used to prevent the infection of the disease, but now the vaccine is used for the dual role of prevention and treatment. About the therapeutic hepatitis B vaccine experts for everyone in detail. At present, the world’s therapeutic hepatitis B vaccine dynamic point of view therapeutic hepatitis B vaccine is mainly divided into genetically engineered protein vaccine, DNA vaccine, DC vaccine and so on. Therapeutic hepatitis B vaccine is hoped to break the immune tolerance of hepatitis B patients and carriers, so that the vaccine can help the human body to kill the hepatitis B virus “autonomously”. Therapeutic hepatitis B vaccine is a vaccine developed by Chinese people themselves, which is significantly cheaper than existing antiviral drugs, alpha interferon (including long-acting interferon), and various nucleoside analogs. Experts said that the therapeutic hepatitis B vaccine into the third phase of clinical is within the scope of the administration of the Drug Administration. The State Food and Drug Administration will be in accordance with national laws and regulations for approval. Therapeutic hepatitis B vaccine into the third phase of the clinical, is within the scope of the administration of the Drug Administration. The State Food and Drug Administration (SFDA) will approve the vaccine in accordance with national laws and regulations. If the vaccine is successfully approved for clinical use, it will be a blessing for hepatitis B patients. Benefits The ideal therapeutic vaccine for hepatitis B is to break the immune tolerance of hepatitis B patients and carriers, so that the vaccine can help the human body to kill the hepatitis B virus “on its own”. The first advantage of the therapeutic hepatitis B vaccine is that it “teaches” the body’s immune system to correctly recognize the hepatitis B virus as an enemy lurking in the body, and mobilize the body’s own immune ability to reduce the replication ability of the hepatitis B virus and eliminate it from the body. The second advantage of the therapeutic hepatitis B vaccine is that the vaccine developed by Chinese people themselves is significantly cheaper than the existing antiviral drugs, alpha interferon (including long-acting interferon), and a variety of nucleoside analogs. Therapeutic Hepatitis B Vaccine Cannot Completely Replace Antiviral Drugs Can Therapeutic Hepatitis B Vaccine Replace Antiviral Drugs? Chinese Medical Association Infectious Diseases Society national member Gong Zuohong said, therapeutic hepatitis B vaccine can not completely replace antiviral drugs, the two will become a new treatment method. Existing antiviral drugs can easily lead to viral mutation, drug resistance, rebound after stopping drugs and other shortcomings, and advocate the application of effective immunomodulators in antiviral therapy to break the immune tolerance, to create conditions for antiviral therapy. Therefore, therapeutic hepatitis B vaccine can not replace antiviral drugs, but immunotherapy and antiviral drugs can be combined to inhibit or eliminate hepatitis B virus in multiple ways, so as to achieve high clinical efficiency and low recurrence.