What is Therapeutic Hepatitis B Vaccine

Therapeutic vaccines are products or products that are natural, synthetic, or expressed by recombinant genetic technology to achieve treatment or prevent disease progression by inducing a specific immune response in an organism that has been infected with pathogenic microorganisms or has suffered from certain diseases. To use an analogy: if the bad guys want to enter the border, this will be guarded by border troops to keep them out; once they enter, this will depend mainly on the police and public security to catch them and subdue them. Preventive vaccines (such as the hepatitis B vaccine we use now) are like border troops, playing the role of stopping “the bad guys” from entering and eliminating them in the initial stage. Therapeutic vaccines, on the other hand, are active and specific immunotherapeutic drugs that are mobilized in an emergency to find the target, track the target, and finally eliminate the target. Therapeutic hepatitis B vaccines can be classified as protein vaccines, DNA vaccines and peptide vaccines. Therapeutic hepatitis B vaccines differ from preventive hepatitis B vaccines in that they overcome the body’s immune tolerance, enhance the body’s specific immune response, and provide a therapeutic effect on hepatitis B. Current studies have shown that therapeutic hepatitis B vaccines are effective in producing specific humoral and cellular immune effects. Therefore, therapeutic vaccines are designed to break immune tolerance, rebuild immune response, and stimulate the production of neutralizing antibodies and cellular immune response mainly CTL response in chronic hepatitis B patients, thus achieving the purpose of clearing virus from hepatocytes. On October 23, 2006, the Ministry of Science and Technology of China announced the progress of the development of two therapeutic hepatitis B vaccines with independent intellectual property rights in China. One of them is the third military medical university in Chongqing developed “ therapeutic (synthetic peptide) hepatitis B vaccine ”, is currently carrying out phase II clinical research; the other is the Fudan University and Beijing Institute of Biological Products developed therapeutic hepatitis B vaccine “ B gram ”, is preparing to start phase III clinical trials. In addition, the 458th Hospital of the People’s Liberation Army (Guangzhou Air Force Hospital) developed “therapeutic dual plasmid hepatitis B virus gene vaccine ” also completed the preclinical research work, approved by the State Food and Drug Administration, entered the clinical trial phase. This marks 5 to 8 years after China’s therapeutic hepatitis B vaccine is likely to enter clinical applications. The introduction of the therapeutic hepatitis B vaccine will effectively control the prevalence of viral hepatitis, significantly improve the efficacy of hepatitis B treatment, and will have a positive impact on the control of hepatitis B, the most threatening disease to human beings. The introduction of a therapeutic hepatitis B vaccine will provide a new means of treatment for chronic hepatitis B, bringing hope and vision. However, the therapeutic hepatitis B vaccine is still under research, and the issues of structural changes, vaccine stability, adjuvant selection, individual differences in hepatitis B patients, mutation of hepatitis B virus, vaccine dose, long-term efficacy, and toxic effects are yet to be resolved, so the therapeutic vaccine cannot be put into clinical use immediately. The development of a therapeutic hepatitis B vaccine will require long-term research and clinical trial observation, and even after a therapeutic hepatitis B vaccine is available, vaccine therapy will not replace drug therapy and will most likely end up as a combination therapy. Finally, we would like to remind readers that a therapeutic hepatitis B vaccine offers a new approach to the treatment of hepatitis B, but it will take a long time to become available and is not “the ultimate weapon”. Patients should not delay treatment by waiting for a therapeutic hepatitis B vaccine to become available.