HIV vaccine: waiting-with…

UN AIDS expert Eduard Karamov: HIV vaccine will appear in 10 years

Expert of the Joint United Nations Program on AIDS, Professor Eduard Karamov in an interview with RIA Novosti he spoke about the problems associated with HIV and AIDS in Russia and the world, about what difficulties arise when creating a vaccine and when it will be possible to talk about the victory over HIV. Lyudmila Belonozhko was talking.

– How many people in the world are infected with HIV every year?

– Now about 1.5 million people are infected annually and about 1 million die. Every year there is an increase of 400-500 thousand new cases of infection. Currently, there are about 37-38 million people living with HIV infection in the world, but more than 40 million have already died. That is, the human immunodeficiency virus is the etiological agent of HIV/AIDS is one of the biggest killers at the turn of two centuries.

– And how are things in Russia?

– Compared with Europe, our incidence is higher. We are among the top 10 countries most affected by HIV/AIDS. On average, about 100 thousand people are infected annually (in 2016 and 2017, slightly less). The number of HIV-infected people in our country is higher than in China, despite the fact that our population is 10 times smaller. China pays special attention to this issue, and they have a lot to learn.

– Why is the HIV problem so difficult to solve?

– HIV is one of the most highly variable biological agents in the world. We cite the influenza virus as a standard, which is changing rapidly, new strains appear every year, a new vaccine must be created every year. In the case of the influenza virus, we know how to make a vaccine, so when a new epidemic begins, special laboratories quickly isolate new strains of influenza and transfer them to large manufacturing companies and they produce a new vaccine within two months. And in the case of HIV, it is unclear how to make a vaccine, many scientific issues have not been resolved.

– When can such a vaccine be created?

– A large number of clinical trials are being conducted now. Several interesting candidate vaccines are in development. There is a lot of talk about the mosaic vaccine. In fact, there are several candidate vaccines that show good results already in extensive clinical trials, so I think this is a prospect not of the distant future, but of the next 10-12 years.

For more than 30 years, large-scale research has been conducted in all countries of the world to create means to combat HIV infection. There is no final decision. Antiretroviral therapy provides for lifelong intake of cocktails of two, three or more chemicals, the toxicity of which in itself can be the cause of death.

– What problems do scientists have to solve to create a vaccine against HIV?

– There are three "damned questions" that prevent the creation of a vaccine. Firstly, it is the high variability of the virus. Secondly, there is no cross–protection - vaccination against one strain does not protect against others, that is, it is impossible to create a universal vaccine. Now there are 9 subtypes of this virus in the world and more than 70 recombinant forms (variants) of the virus. The A6 virus is widespread in Russia, and the Americans are making a vaccine against the B virus, this vaccine does not protect against our virus.

Our main virus came from the south of Ukraine in the late 90s and took over the entire post-Soviet space, and in recent years recombinant viruses (between subtypes A and G) have been penetrating together with migrant workers from Central Asia. These viruses, in turn, begin to recombine with our main A6 virus, new strains arise, we must constantly monitor this process.

The peculiarity of the Russian epidemic, unlike the American one, where most of the infected are men who have sex with men, is also that our share of such people is less than 1.5%. But we have more than 50% of those infected are intravenous drug addicts. And special work should be done with them, because drug addicts often interrupt treatment. As a result, HIV strains resistant to many drugs are spreading in our country. It is necessary to apply a strategy of long-term support to drug addicts, to control the process of taking medications, because without this they pose a threat not only to themselves and their loved ones, but also to the whole society.

And the third problem is the lack of laboratory animals on which to test the vaccine. Chimpanzees who have a virus that is closest to a human one are infected, but do not get sick. And the macaque virus, which leads these animals to a quick death, is very different from the human virus, so all vaccine tests have to be carried out on humans.

– How are the tests conducted?

– How to check if the vaccine works or not? They take a large cohort of people, some of whom receive a vaccine, and the rest – a placebo (dummy). The cohort is recruited in such a region or such a risk group where the increase in this infection is at least 10% per year. Thus, in a control group of 5,000 people, about 500 will become infected, and in a group of 5,000 vaccinated, the number of infected will be less (if the vaccine is effective). Such studies last at least 3-5 years. It's a lot of hard work, but it has to be done. No one will make a vaccine for Russia on Russian HIV strains, no one needs it. Creating an HIV vaccine is a key solution to the HIV problem/AIDS.

– And in Are such studies conducted in Russia?

– Unfortunately, in Russia such studies are practically curtailed. In October 2015, the situation with HIV was analyzed at a special meeting of the Government of the Russian Federation/AIDS. Today, the epidemic has affected more than a million Russian citizens, almost 300 thousand of them have died.

This is a very serious problem for our country. What is 300 thousand people – this is the population of a large city, and these are people aged 16 to 40 years – these are young people who could leave offspring. Perhaps they will leave him, but who will raise these children, they will remain orphans. And their parents, who could count on the help of their children in old age, will not receive this help. We are already suffering enormous demographic damage from HIV/AIDS.

– What studies were conducted in Russia?

– Implementation of the first national program for the development of an HIV vaccine in Russia was started in 1997 and stopped in 2005. These years were not lost in vain, three domestic candidate vaccines against HIV were created, all of them passed preclinical tests in three centers – in Moscow, in St. Petersburg and in Novosibirsk. In 2006, when our country hosted the G8 Summit, Russia, together with other participants, supported the idea of developing an HIV vaccine. With the direct support of President Putin, a domestic program for testing candidate vaccines was funded from 2008 to 2010. All three domestic candidate vaccines have passed the first phase of clinical trials. After that, the state financing was discontinued. This led to the fact that serious research teams that dealt with this problem broke up.

By the way, the vaccine made by Moscow immunologists was included in the shortlist of the best candidate vaccines in the world.

There was also a competitive grant from the Ministry of Industry and Trade under the Pharma 2020 program, it was won by the St. Petersburg research team in 2013, and in February 2016 funding ended. St. Petersburg scientists managed to conduct the second phase of clinical trials of the vaccine.

– Which vaccine is the most effective today?

– The best vaccine that has been tested to date was tested in Thailand, the results were published at the end of 2009. The vaccine was administered several times during the first year, and then two years of observation were conducted. It turned out that this vaccine protects 60% during the first year, and after 3 years – 31% of people. This is not enough, you need at least 60-70%.

– Do you think our authorities are aware of the importance of the HIV problem?

– In recent years, the Government and the Ministry of Health, including, have been paying great attention to this problem. Back in 2015, Prime Minister Dmitry Medvedev instructed the Ministry of Health and other ministries and departments to develop a state strategy to combat HIV infection in Of Russia. Now this strategy has been adopted, it is aimed at raising awareness of citizens who are informed about measures to prevent the disease (promoting a healthy lifestyle, family and moral values). This is right and necessary, but we must not forget that the HIV epidemic is a biological threat, including to the existence of the country. An effective response to the epidemic is possible only with the active participation of science in the development of new drugs, microbicides (drugs that prevent sexual transmission of HIV) and vaccines. And the promotion of healthy lifestyle should only complement specific measures to combat HIV infection.

Health Minister Veronika Skvortsova knows the problem well. In recent years, it has been possible to significantly improve the provision of medicines to HIV-infected people. Now about 33-34% are receiving treatment, and more recently it was only 10%. That is, for several years, the Ministry of Health has managed to achieve serious success even in difficult financial conditions.

The problem of HIV infection is not only a problem of the Ministry of Health. This is a problem for the whole country. An interdepartmental body should be created, which should include many ministries and departments from the Ministry of Education and the Ministry of Science to law enforcement officers and legislators.

The Ministry of Science should play a significant role in solving this problem. Who should develop new drugs? Who should give grants to our chemists, biologists to create new vaccines, new microbicides? This is also the Ministry of Science, and not just the Ministry of Health. An interdepartmental commission should be created, which should be supervised by the presidential administration or the government, because this problem goes far beyond one ministry. It is wrong to entrust this work only to doctors. This is a strategic mistake that was made in Of Russia.

– What new HIV-related problems have been emerging recently?

– Another big problem is the joint infection of HIV-tuberculosis. We have about a third of all new cases of HIV infection complicated by tuberculosis. This is a terrible disaster. The infection becomes much more aggressive, lightning-fast. These people do not live long, they lack one antiretroviral therapy, they definitely need powerful therapy for tuberculosis. But the Ministry of Health and the chief phthisiologist of the Ministry of Health, Professor Irina Anatolyevna Vasilyeva, are working very actively in this direction.

– Is a therapeutic vaccine being developed for already infected people?

– Recently, a lot of attention has been attracted by therapeutic vaccines, those that can be given to people who are already infected. Such a vaccine is not intended to prevent infection. It maintains a high level of T-cell immunity, which can control the level of virus replication even in the absence of antiretroviral therapy. We are preparing for trials of the Moscovir therapeutic HIV vaccine, which, I hope, will begin next year.

– When can we talk about the victory over HIV?

– Probably not earlier than in 25-30 years. Many are now talking about the victory over HIV, meaning the creation of highly effective antiretroviral therapy schemes, when constant medication allows you to control the viral load, but it will be possible to radically solve this problem only with the creation of a set of biomedical prevention measures, including effective vaccines, microbicides and means of pre-contact prevention.

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