29 November 2010

St. Petersburg HIV vaccine: first-hand details

Professor Andrey Kozlov – about the AIDS vaccine and science in RussiaAlexander Sergeev, Radio Liberty
At the first stage of clinical trials, a new AIDS vaccine is tested for safety and immunogenicity.

Previously, it has already been tested in detail on animals – rabbits, dogs, mice, guinea pigs. And now it has been introduced to two dozen healthy volunteers, whom scientists will observe for several months. Then the group of subjects will be expanded. If there are no safety problems, then in about two years we can expect a transition to the main phase of clinical trials – testing the vaccine for effectiveness in preventing AIDS infection.

Andrey Kozlov, a professor of St. Petersburg University, director of the Biomedical Center and head of the laboratory of the State Research Institute of Especially Pure Biological Products, Doctor of Biological Sciences, directs the development and testing of the vaccine, who talks about the ongoing research and the trials that have begun.

– The search for an AIDS vaccine has been going on for the second decade. Why was it so long and difficult?

– Systematic work on the AIDS vaccine began in 1997, after the relevant decision taken by the Big Eight. Clinton wanted to make a vaccine in 10 years. Failed. And other vaccines cannot be made in ten years. The average development time of vaccines is 20-30 years or more. Although, apparently, it is really more difficult to create an AIDS vaccine, because the disease is more complicated. The disease is chronic, has been developing for many years, is sexually transmitted, affects the cells of the immune system, the virus is very diverse and embedded in the genome. And all this together makes both the disease and the virus the most complex of those we have encountered so far.

– The problem is that the human immunodeficiency virus attacks the very T-lymphocytes that are supposed to attack it. Hunters become victims themselves. How do you manage to open this ring?

– Well, it's not possible yet, I must say. Only a few vaccines have reached the stage of efficacy testing, and they have not shown any dramatic protective effect. Of course, we have hopes, because there is no other way for humanity: either we will develop a vaccine, or we will disappear altogether. In this regard, I must say that the vaccine will, of course, be associated with the discovery, and therefore it is impossible to say the exact date of its appearance. It is only clear that we are going in the right directions. In particular, one of these areas is working with the acute phase of HIV infection, which occurs within a few days after infection. It turns out that it is in this phase that the greatest amount of virus is contained in the blood, and the body makes a fundamental decision how to deal with this viral infection: to die or fight. Therefore, it is necessary to develop a vaccine specifically for the virus in the acute phase. And in this direction, our discovery was made that when drug addicts become infected, the infection is caused by one viral genome, one viral particle. Prior to this, similar data were obtained for sexual infection. And together these two discoveries are of great importance for understanding the pathogenesis of viral infection. The vaccine will have to be made against these particles that infect. In the advanced phases of the disease, there is a huge mixture of viruses in the patient, but it turns out that only some have the infecting ability. Therefore, to study the properties of those that infect, and to pick up the keys to them – this is the task of the moment. And the journal Science published a special editorial on this topic, where he wrote that the Russians had made a discovery far beyond the borders of Russia. And in an area where there are simply no Russian works.

– Reports about AIDS vaccine trials appear in the press with enviable regularity. But there are no reliable reports of positive results. What allows you to hope for success? After all, dozens of other research groups have not achieved anything.– There are positive results, they appeared just in the last year.

Just the last vaccine in clinical trials showed 30 percent effectiveness. It is necessary, of course, 90% and more, but so far we have what we have. As for our vaccine, we are making a specific regional vaccine – only for Russia. It is based on the Russian isolate of the virus. The fact is that in Russia, 90% of HIV infection is still caused by a single viral isolate, it has very little genetic diversity. And all the vaccines that worked, just worked on a low variety. Every year a new flu vaccine is made precisely because of this diversity, so that it can be done all the time for what it needs. And here we are doing exactly what we need.

– How many scientifically significant attempts have there been in the world to create an AIDS vaccine? How far did these works go?– Dozens, dozens!

America has a whole system through which a lot of candidates scroll through. There are a lot of preclinical trials, fewer clinical ones, and only three have reached efficacy tests. And many laboratories say, "Here we are making a vaccine," but this vaccine will never reach (and it is not even planned) to the stage of efficacy testing. And 10 years ago we started working with a cohort of patients, which we will use at the stage of the third phase of clinical trials. We do it better than anyone in the world. We will bring our product to the third phase, because we actually have this third phase in our hands – this very cohort. And other people do and do not think that sometime they will have a third phase. No one has cohorts, but we already have. Here I said that the best vaccine works with an efficiency of 30%, and we are already changing the behavior in the cohort with an efficiency of 50%. Only by changing the behavior in our cohorts, the behavior is halved. And this is another result that deserves attention.

– That is, the current work on the vaccine is the result of many years of purposeful activity. And how many employees are working on the vaccine now?– About 50.

A consortium of organizations is working on the vaccine in St. Petersburg, which includes St. Petersburg State University, the State Research Institute of Especially Pure Biological Products and the Biomedical Center, where I am the director, which is not a state one. These 50 people work at the Biomedical Center. That is, this is a new form of scientific organization – one of the forms that the president, the prime minister and the government are looking for. It seems to me that we have found such a form of scientific organization – it is small, mobile and effective here in Russia, despite all our mess. That is, after all, the relative freedom that we have allows us to do miracles. Our work – both the vaccine and the discovery – is the product of twenty years of efforts by a huge team. And we have gone through the crisis, the default, and the departure of specialists over these 20 years. And this is a good example of the fact that we can make discoveries here.

There is a discussion going on here now – Skolkovo, not Skolkovo... There is an opinion that it is necessary to establish democracy first, and then Skolkovo. This is correct, only in an environment of freedom can you make discoveries. In the situation of administrative and command management, discoveries are impossible or very difficult. For example, the period of the 90s was significant for our group in that, although there were great difficulties, there was freedom. And it helped a lot to do science.

Portal "Eternal youth" http://vechnayamolodost.ru29.11.2010

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