China's AIDS vaccine "win" geometry?

recently, there are media reports: China'
vaccine next year to apply for phase III clinical trials.
stone stirs up a thousand waves.
37 years since the start of research and development, hundreds of clinical trials have failed, next year may open phase III clinical trials of China's
vaccine "win" geometry?
December 17th, a reporter from Science and Technology Daily went to the Chinese Center for Disease Control and Prevention of Sexually Transmitted Diseases
Prevention and Control center to interview Professor Yiming Yan, head of the research and development team and the chief expert of the
of the China Center for Disease Control and Prevention.of repeated failures has shown
the design of a vaccine against the virus must be courageous.
the end of the last century, Yan Yiming learned that only two international clinical trials of the replicate pox virus vector
vaccine had been conducted, and then interrupted.
, the CDC
vaccine team led by Nie Yiming has selected a replica viral vector carrier to conduct the first phase of the
vaccine research clinical trial, which showed good safety.
Yiming went to the U.S. specifically to find scientists working on both trials to ask why, and learned that the termination of the study was not due to technical reasons, but rather the commercial decision of pharmaceutical companies to withdraw from vaccine-focused drugs.
" replica carrier is a live virus that will multiply in the body for a period of time after inoculation, neither continuing to stimulate the immune system or the immune system's familiar natural virus attack, which induces a stronger and longer-lasting immune response. This new immunization strategy is conducive to a "long-lasting battle" against chronic viral infections with a long incubation period of HIV (8-10 years), and traditional and conventional vaccine techniques are only effective for acute viral infections such as neo-coronavirus (incubation periods of 1-2 weeks).
It is generally believed that replicated live carriers are not as safe as non-replicated dead carriers, the choice of bad safety events, will make multinational pharmaceutical companies involved in other pharmaceutical products and cause losses, which is the main reason for enterprises to abandon this route.
"We chose the self-intellectual property-based replica pox virus 'Tiantan strain' as the
vaccine carrier because it has the longest history of safe applications in the last century in the campaign to eradicate smallpox. He said.
years, the international research team has gradually recognized the advantages of the replicated carrier route, and gradually carried out the
vaccine research. So far,
, such vaccines in other countries, such as the United States, have 1 phase completed or are in progress, according to the International Organization for Vaccine Action (IAVI). China
phase I and II clinical trials of the anti-virus vaccine, ranking first in the process.if the carrier of the Temple of Heaven solves the problem of "enduring war", then the "nuclear" carried by the carrier will determine whether it can be "precision strike".
and
drug
dozens of years of Yin Yiming understand that "nuclear" must be "high imitation
poison and transformation, in order to stimulate effective immune protection.
biggest challenge is "high imitation". Yan Yiming decided to jump out of HIV and look for clues in the lysovirus of the same genus. In 2001, Yan Yiming was lucky enough to find Shen Rongsheng
of the Harbin Veterinary Research Institute, which developed the world's first lyovirus vaccine, the EiAV
, and obtained the EIAV detoxifying live vaccine.
And Shen
teamed up for more than ten years to determine the EIAV detoxification process of hundreds of generations of cell culture and to determine the key genetic mutations that convert highly pathogenic wild strains into safe and effective vaccine strains. Using structural biology and bioinforminformation techniques, they then produced "high imitation" maps to transform HIV immunogens, including determining which glycosylation site to remove, and transforming which protein's compositional structure . . . to achieve "refining" of HIV natural immunogens.
" stimulates antibodies produced by immune animals, not only effectively to the vaccine immunogenic hiv strains, but also to the different HIV strains, resulting in a broad-spectrum immune protection effect. He said. disease control and the National Pharmaceutical Co. , D.C. in cooperation with the development of a replica virus vector "HIV vaccine production costs will be very low, less than one yuan a dose. At present, vaccine research in
developing countries must initially be considered for application to avoid "nobility".
, the vaccine has completed the first phase of clinical trials at Concord Hospital in Beijing and the first phase II clinical trials at You'an Hospital in Beijing. Currently, Phase 2 clinical trials are being conducted at Beijing You'an Hospital and Zhejiang University First Affiliated Hospital. A total of 400 people participated in the above-mentioned phase of clinical trials, high-dose group of volunteers can produce anti-HIV antibody response, 2/3 of the volunteers also have cellular immune response, found no serious adverse events, the vaccine is safe.
"We initiated the study sample testing and preliminary data analysis ahead of schedule, and next year we will only need to add the final follow-up data results as planned to uncover the final data analysis." We submit phase III clinical applications at the same time as we submit our research report. 'Phase III clinical trials will answer the question of vaccine protection rates and will be approved to launch large-scale clinical trials, which are expected to be completed within three years to obtain china's independently developed
vaccine immune protection data,' he said.
at the same time, china and the United States signed an agreement to conduct a joint clinical trial of the HIV vaccine due to the technical complementarities between the CDC replication pox virus vector vaccine and the U.S. National Institutes of Health's replication pox virus vector vaccine. Currently, teams from both countries are preparing to apply to the National Drug Administration for clinical trials.