31 people have been vaccinated with HIV vaccine in clinical trials in China

31 years after the discovery of AIDS, the first drug for the prevention of uninfected people was approved by the US FDA on July 16 this year At the 19th World AIDS conference, which ended 10 days later, the first person to be cured appeared, and people saw the dawn of controlling the AIDS epidemic According to a reporter from Beijing Youan Hospital, the phase II clinical trial of China's major science and technology special HIV vaccine was launched in the hospital last week, and the first 31 subjects have received the first injection Progress The effectiveness of the vaccine will be verified compared with the high cost of AIDS treatment drugs After a few shots, it is more economical and effective to dispense with the vaccine China CDC and Sinopharm Beijing Institute of biological products adopt a new method to jointly develop an HIV vaccine with full independent intellectual property rights The vaccine completed phase I clinical trials during the 11th Five Year Plan period, showing good safety and strong immunogenicity, which can induce the subjects to produce humoral and cellular immune responses against HIV Phase II trials will be further tested To prove its immunogenicity, that is, whether it is effective or not This is the first time in the world to use the replication of live virus vector to develop HIV vaccine into clinical trials At present, 31 people have received the first injection The expert group of the AIDS vaccine research said that AIDS is one of the most serious public health threats facing mankind at present Although the global AIDS prevention and control funds are increasing year by year, the drug treatment of HIV infection is constantly promoted, the epidemic trend of AIDS is still beyond people's estimates According to reports, by the end of 2009, there were about 33.3 million people living with HIV in the world By the end of 2010, there are about 760000 people living with HIV and AIDS in China In 2010 alone, the number of new HIV infections in China is about 48000, with 14000 deaths According to our national defense plan, by the end of 2015, the number of infected people and patients alive will be controlled at about 1.2 million Expert group said that at present, China's AIDS epidemic growth trend is obvious, the high-risk groups of AIDS epidemic has not been effectively controlled, and began to spread to the general population, the peak of AIDS incidence and death in some areas has come The expert group admitted that although China's self-developed HIV vaccine has entered the second phase of clinical trials, it is two years later than the goal of "developing and completing clinical trials of HIV vaccine against China's epidemic strains by 2010" proposed in China's medium and long term plan for AIDS prevention and control released in 1998 Combo with China's AIDS vaccine In order to "suit the case", DNA vaccine is "customized" according to the blood of HIV positive intravenous drug users in Yunnan Province This time, China adopted the "nucleic acid vaccine and recombinant Tiantan vaccinia combined immune AIDS vaccine", the role of "prevention of HIV infection" It is composed of HIV-1DNA vaccine and recombinant vaccinia virus (hereinafter referred to as DNA vaccine and "vaccinia") AIDS vaccine The former constructs an immune barrier in human body, while the latter strengthens the barrier "Both the antiviral treatment of AIDS patients and the treatment of tuberculosis patients are combined drugs," said Xia Wei, a physician at Beijing You'an Hospital who participated in the trial In order to enhance the immune effect, the AIDS vaccine was also combined injection, which is one of the biggest differences between China's "national" AIDS vaccine and foreign countries The subjects were first vaccinated with three DNA vaccines, one month apart, and then randomly divided into groups and injected with "vaccinia" at different intervals, which could "significantly enhance the induced humoral and cellular immune response, which is superior to DNA vaccine alone" According to the expert group, worldwide, AIDS vaccine has a research history of more than 20 years Vaccine forms mainly include traditional vaccine (inactivated vaccine and live attenuated vaccine), virus like particles, synthetic peptide vaccine, protein subunit vaccine, DNA vaccine and live vector vaccine, but the reason for its failure so far is that each test has obvious disadvantages A successful vaccine that will be widely used needs to be "100% safe and 100% effective" China's AIDS vaccine in this trial is standing on the "shoulder of the predecessors", excluding the shortcomings of other methods In order to "prescribe drugs according to the specific situation", DNA vaccine is "customized" based on the blood of HIV positive intravenous drug users in Yunnan Province Pre virus DNA is extracted from peripheral blood monocytes infected by the experiment, and obtained after genome amplification and sequencing Carrier smallpox vaccine back to the post to undertake the heavy task of AIDS prevention Through gene technology, the HIV fragment was intercepted and put on the vaccine vector for smallpox treatment to cultivate a new vaccine In 1980, who officially announced that smallpox had been eliminated in the world As a big country with smallpox epidemic, China has made indelible contribution to the success of Tiantan vaccinia virus In the developed AIDS vaccine, "vaccinia" is exactly the replication type of Tiantan virus Why choose smallpox vaccine that has been retired for more than 30 years? Professor Shao Yiming, who is in charge of the research group of this experiment, said that China's AIDS vaccine research does not repeat the existing routes abroad, so we have developed an AIDS vaccine using vaccinia invented by our older generation of scientists as the carrier, which is a new carrier never seen in more than 100 experiments in the world at present Compared with other smallpox vaccines used in the world, vaccinia vaccine has been produced in China for more than 10 years in a row, with less serious side effects and guaranteed safety According to reports, there are two types of AIDS vaccine: "live vaccine" and "dead vaccine" The dead vaccine will not reproduce in the human body, and it will decrease with time The live vaccine will split and reproduce in the human body, with much stronger effect and much longer lasting Compared with the two vaccines, the dead vaccine is relatively safer, but the cost is very high; the live vaccine is less safe than the dead vaccine, but the cost is low The research and experiment of our country is live vaccine: through gene technology, the HIV fragment is intercepted and put on the vaccine carrier of smallpox treatment to cultivate a new vaccine Compared with the dead vaccine, the "lower cost" of the live vaccine is conducive to the promotion and use after success Safety pika monkey to verify the safety of the vaccine The results showed that monkeys had built an effective barrier against HIV in their bodies Is the AIDS vaccine put into phase II a trial safe? This has been verified in mice, rabbits, rhesus monkeys and other animals The ultimate goal of this trial, the effective immunity to HIV, has also been preliminarily confirmed in these animals close to human body The experiment on 12 rhesus monkeys showed that the immune effect of the experimental group using "3 + 1" method was obvious compared with that of the experimental group using only DNA vaccine and vaccinia vaccine The "physical examination" evaluation of the monkeys in this group showed that the immune response of the monkeys was significantly enhanced after adding the key injection of DNA vaccine - "vaccinia", and the positive rate of antibody and cell immune response was 100% 。 This means that monkeys have built effective barriers against HIV in their bodies In terms of safety, the physical examination of the tested animals from the general state, anatomy and pathology, hematology, serology and other aspects showed that after the test, "the body is in good condition", and the weight and appetite are not affected The animal test confirmed that it was 100% safe, which laid the foundation for human injection and expansion of the test scope "Except for the possible local adverse reactions, there was no damage to the subjects." the relevant person in charge of the research group said that 48 subjects in the vaccine phase I test did not have any adverse reactions, and in the phase II test, the subjects would be closely followed up, even if they had a cold or thin skin After a few Jin, the observer will record it and then judge whether it is caused by vaccination Xia Wei, a physician who participated in the project in Beijing You'an Hospital, introduced that in this clinical trial, the subjects will be followed up, observed and finally evaluated according to the safety index and immunogenicity index The former includes vaccination reaction, blood routine test, liver and kidney function, electrocardiogram, etc., and the latter is nearly 2% of the subjects' humoral and cellular immune positive rate related to vaccination 0 indicators Way: take "tram" to guard against AI DNA In about 10 seconds, the DNA "warrior" with the mission of "fighting against HIV" will successfully enter the subjects and start the defense war Experts said that up to now, most of the clinical trials of DNA vaccine showed that its immunogenicity is weak, and the induced immune response is still not enough to achieve the preventive or therapeutic effect One of the important reasons is that the current DNA vaccine is mainly immunized by simple intramuscular injection Generally speaking, the improper injection mode directly leads to the low success rate of the effective ingredients in the vaccine being delivered to the designated place in the human body In this way, it is difficult to build a "protective wall" in the body to avoid the invasion of HIV But using electricity as a medium of communication may break through the dilemma of failure The research team said that in recent years, the application of pulse technology in the field of DNA vaccine is increasing, and foreign research shows that it can significantly enhance the immune response induced by DNA vaccine in animals Therefore, in order to further verify the effectiveness of this method, in this experiment, a group of subjects were selected for electric pulse injection In this group of subjects, the first three DNA vaccines adopt the way of "electric pulse" In the electric field formed by the application of electric pulse, the plasmids in DNA will be "smoothly and unimpeded" to the cells of the subjects In about 10 seconds, the DNA "warrior" with the mission of "fighting against HIV" will successfully enter the subjects and start the defense war.