Medical Network October 12th The National Major New Drug Creation Project "Human Pickup
Rabies Vaccine" was recently awarded a clinical approval by the State Food and Drug Administration of China, allowing it to conduct Phase III clinical trials in China. Yu Yongxin, an academician of the Chinese Academy of Engineering, said in Beijing on the 11th that the
Vaccine was approved as a therapeutic vaccine and could be said to be a breakthrough.
On the same day, the international multi-center clinical research seminar and press conference of the national major new drug creation project “Human Pickup Rabies Vaccine” was held in Beijing. The experts discussed the international multi-center clinical research plan of the vaccine and the State Food and Drug Administration. The content and requirements of the approved clinical trials are discussed and analyzed.
According to reports, human rabies vaccine can activate Toll-like receptor 3, rapidly induce strong cellular and humoral immunity, protect the body from rabies virus infection, and greatly improve the protection rate of vaccine. In addition, compared with the existing commercial rabies vaccine, which requires three to four weeks of multiple injections of the standard immunization protocol, the immunization protocol of the vaccine three times a week will greatly improve the compliance of the immunized population.
The human rabies vaccine is a therapeutic rabies vaccine. Therapeutic vaccine refers to the body after infection or
disease, method of generating specific immune or non-specific immunity by inducing the body to prevent the occurrence of diseases, development, or promote the body's disease has produced back to
health. Prophylactic
Vaccines are used in organisms that have not yet been infected, so that the immune system is ready to make a timely immune response if pathogens invade in the future.
It is understood that at present, the World Health Organization recommended rabies III post-exposure treatment methods include wound treatment,
Injection of rabies immunoglobulin and vaccination against rabies. The results of the study showed that the use of vaccine alone after rabies exposure did not effectively block the onset of rabies.
Yu Yongxin said that due to clinical habits and other reasons, only about 30% of the exposed people injected rabies immunoglobulin. In the absence of rabies immunoglobulin, the protection rate of the pickup rabies vaccine can reach 80%, and the protection rate of the current rabies vaccine is only 20%-30%.
It is reported that at present, the vaccine has successfully completed Phase I and Phase II clinical studies overseas, and has launched an international multi-center Phase III clinical trial.
July 02, 2021
