This human clinical trial data shows that AIDS can be completely cured?

Release date: 2017-08-11

The AIDS that humans have been tackling on is finally getting medicine and healing. Can it be healed?

Gratifying human test data

Recently, a message about "Johnson announced the results of clinical trials of HIV vaccine: 100% of volunteers produce antibodies" was strongly screened.

On July 23, at the World AIDS Conference Virus Science Conference (IAS) in Paris, Johnson & Johnson's Yangsen Pharmaceutical announced the development of a AIDS preventive vaccine, the mosaic vaccine.

On July 24, Johnson & Johnson announced the results of the world's first human clinical trial of HIV vaccine. The vaccine was clinically tested in 393 healthy volunteers recruited in the United States, Rwanda, Uganda, South Africa and Thailand. The results showed that volunteers were resistant to mosaic vaccines. The sex is good and the antibody is produced 100%.

What is a mosaic vaccine? Is there such a magical power?

According to public information, the so-called mosaic vaccine, which uses a combination of multiple antigens (gene fragments) of HIV, forms a vaccine that has a strong stimulating effect on the body's immune system and can produce effective antibodies, called appROACH vaccine. The appROACH vaccine is first and foremost exciting. In addition to 100% anti-HIV antibody production in subjects, the risk of infection was reduced by 94% in a single exposure to HIV (HIV), and 66% were exposed to HIV 6 times. Still protected and not infected with HIV.

Mosaic vaccine

According to the Beijing Daily, the vaccine trial used the “primary-boosting” strategy, in which the subjects received a total of four vaccinations, the first two vaccines were priming, and the last two vaccines were booster vaccinations. After 48 weeks of injection, the subjects did not produce any side effects, and blood tests revealed antibodies against HIV in all humans. The risk of HIV infection was reduced by 94% in the actual assessment of the subject's protection.

The main reason for the significant effect of the AIDS mosaic vaccine is that the vaccine is designed according to the characteristics of HIV. The most important thing is to use multiple antigens of HIV, that is, genes from a plurality of different HIV subtype strains, which pass the viral vector. Generated to form a vaccine containing multiple HIV antigens.

Animal experiment completed 4 years ago

In 2013, researchers at Harvard Medical School and other institutions published a report on Cell, which they developed a "mosaic vaccine" that spliced ​​multiple genes. Animal experiments have shown that the vaccine can reduce the risk of HIV infection by about 90%. This research may bring new hope to human "anti-AIDS".

Scientists have long been suffering from the rapid evolutionary capabilities and diversity of HIV, and the “mosaic vaccine” is also called “mosaic vaccine”. It is based on the analysis of a large number of viral gene sequences and human immune responses. Optimized gene sequences produce vaccines that induce the body to produce a broader immune protection response covering all common HIV subtypes. After the large-scale clinical trial of AIDS vaccine RV144 in Thailand in 2009, it became the core research of AIDS vaccines preferred by researchers in various countries. At that time, large studies in Thailand showed that RV144 can only reduce the HIV infection rate by 31%, but it is already the most effective. vaccine.

The researchers also said that they have developed a "mosaic vaccine" using the three major proteins of HIV, Env, Gag and Pol. After inoculation of the vaccine to rhesus monkeys, the most pathogenic human monkey chimeric immunodeficiency The virus (SHIV), which simulates natural infections, attacks them six times in order to test the vaccine effect. At the end of the trial, the researchers found that although only 12 healthy rhesus monkeys were vaccinated after the virus had been attacked for six consecutive times, the calculations showed that 12 rhesus monkeys with and without vaccination (all after 3 attacks) Compared with infection, the "mosaic vaccine" has a protective effect on rhesus monkeys as high as 87% to 90%.

Dr. Liu Jinyan from Harvard University, who was involved in the study, said to the media: "This means that if humans are also vaccinated with 'mosaic vaccines', the chance of contracting HIV may be reduced by about 90%."

In addition, the researchers pointed out that the previous AIDS vaccine trials were mostly directed against the less pathogenic viruses, and the human monkey chimeric immunodeficiency virus they tested was the most pathogenic. In addition, the dose of challenge used in the trial was 100 times that of humans exposed to HIV through sexually transmitted infections.

However, experts are not so optimistic

In the case of animal test data and human trial data are more gratifying, some netizens began to sigh "HIV has to be extinct, cancer is not far away", but the relevant experts and scholars do not think so.

Lu Hongzhou, a member of the National Health and Family Planning Commission for Disease Prevention and Control, told the media that the active ingredients of the virus will also produce antibodies after stimulating the human body. The presence of antibodies does not mean protection, nor does it prevent HIV infection and replication.

Lu Hongzhou said that the vaccine needs to be extensively controlled after human trials, that is, the high-risk population is divided into the vaccinated group and the non-vaccinated group. If the vaccinated population does not get infected, it is obvious compared with the control group. The vaccine is protective. The observation cycle takes several years and it is unlikely that there will be obvious effects in the short term.

According to the news report, Wang Yuge, a postdoctoral fellow at Harvard Medical School in the United States, also put forward a similar point: the test data does not prove that the vaccine is effective. The antibody produced by this vaccine is a normal reaction, but it does not indicate that it produces a protective antibody. The purpose of the HIV vaccine is to induce protective antibodies, especially specific antibodies against HIV viruses, but some of the results disclosed by Janssen Pharmaceuticals do not give the neutralizing activity of the induced antibodies and the broad spectrum of antibodies. the result of.

Zhang Linqi, a professor at the Center for AIDS Comprehensive Research at Tsinghua University, pointed out that our understanding of the protective immune response against HIV is still incomplete. It is impossible to determine whether the antibody response induced by it is protective and requires a larger number of human trials to study and analyze. The final evaluation of the effectiveness of this vaccine will take at least 5-10 years to see the results.

In addition, some experts pointed out that the above "also reduced the risk of infection in a single exposure to HIV (HIV) by 94%, and 66% were still protected under 6 exposures to HIV." The data is not from the human clinical trial of Janssen Pharmaceuticals, but from pre-clinical animal tests, ie monkeys, whether this data is still available in human trials, and it is not known.

Therefore, experts have come to the conclusion that it is too early to conclude that “AIDS diagnosis is to be cured”. Although mosaic vaccines have shown encouraging results, more trials are needed to prove the effectiveness of the vaccine, at least The number of people should be similar or equivalent to the AIDS vaccine RV144 conducted in Thailand in 2009, when 15,000 people participated in the trial in Thailand.

It is reported that a larger clinical trial of the APPROACH project is under planning. If it is successful, 2,600 healthy women will be recruited in South Africa in late 2017 or early 2018.

Source: Medical Valley

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