23 July 2010

How the safety of the HIV vaccine was tested on me

The media buzzed about the beginning of clinical trials of the Russian HIV vaccine.

"Vesti" retells the words of the specialists of the scientific center "Vector" briefly and incomprehensibly:
The AIDS vaccine will be tested on volunteers. The development of a unique drug is fully completed. Now it needs to be checked for security. The components of the vaccine – "Combivichvak" – stimulate the immune system, and if the virus has entered the cell, they recognize it and kill it. Vector has received all official recommendations for conducting clinical trials. The vaccine research is planned to be completed this year.

"NGS.NOVOSTI" quotes verbatim from a message from the Vector press service that was clearly not intended for dummies:
The candidate vaccine "Combivichvak", combining B– and T-cell immunogens in one nanoconstruction, induces a strong immune response to infection, and the antibodies are highly specific, they not only recognize HIV-1 antigens, but are also able to neutralize the virus in the system in vitro...

But God be with them, antigens-immunogens. Let's not get into the wilds of immunology, and there the specialist will break his leg. Better read the memoir of one of the volunteers, an employee of Vector, who hid in a blog under the nickname addicted_to_love.

The first phase of clinical trials of Combivichvak

The Department of immunotherapeutic drugs has created a combined vaccine against the human immunodeficiency virus. It consists of two components: protein and protein. Together, they contain a bunch of viral epitopes from conservative areas, both B-cell epitopes, and CTL and T-helper epitopes. The idea is very good, the topic is very relevant. At the end of 2009, GISK admitted the vaccine to clinical trials. We celebrated with the whole department.   I did not take any part in the development of Combivichvak, but I had the opportunity to participate in the first phase of clinical trials as a volunteer. Having assessed the risk, I underwent a full medical examination, and on Thursday, June 10, we were hospitalized for the purpose of constant monitoring of our condition.

They put us in Building 19, where there are several research boxes, but which is mainly designed to isolate patients with particularly dangerous viruses, which is quite natural, since they work with all sorts of smallpox, hemorrhagic fevers and other terribly dangerous viruses on the Vector, and there have been cases of infections with even fatal outcomes. This building is a one-story building with looping corridors and cabins inside.    Yes, they look like cabins. Submarines. Only, I think, more in size. They look like exclusively sealed doors (I checked, you can also use "doors"), which are just even similar in size to submarines, and Dasha said that she was told that they are really the same on submarines.

Each room has two beds, a bath with a shower and a toilet (without any visual isolation), a door to the street. We were the only ones of all the volunteers who had passes, so we dragged ourselves to work to look down on the Internet and share our impressions with colleagues.

And there are no special impressions. We were vaccinated on June 10 at almost 11 o'clock in the morning. A painful prick in the shoulder with a thick needle – and that's it. Painful solely due to the fact that a large volume was injected, painful for only a couple of seconds, but Dasha burst into furious indignation. In general, it is this trait that annoys me in her – fastidiousness. Well, perhaps also by putting his desires above his duty. It sounds kind of pompous, but it expresses the essence. Dasha is a separate story, a complex person.

Well, that's it. A painful prick – and that's it. There are no more sensations. We spent the night in the dispensary, in the morning they took some blood from us, measured the pressure and temperature as usual, but they did not let us go home, as promised, because one of us had a high fever, because he had the sense to smoke in the gentle summer sun before vaccination, which just flared up at the beginning of the week. This was another reason for Dasha to get angry, to fret into the trash. After lunch, we were still allowed to go home, having made us promise to call in the morning and in the evening to report body temperature. For the sake of this, I even bought an electronic thermometer, which I am not happy about, because it is much more convenient to measure the temperature orally for 15 seconds than 5 minutes under the arm, and, as the manufacturer assures, it is much more reliable.

When we were examined before hospitalization, we signed a contract where everything is described. But one man who works next to us in the first building, in the ETS, said that once upon a time he also participated in clinical trials. But they didn't sign anything and didn't even know what they were being told. There were times. It's creepy.

In general, people have some kind of fear of participating in clinical trials. For example, my parents. And I'm not experiencing anything at all. Because, being a specialist, I assessed the possible risks. They are minimal. So I participate. Although I don't really need immunity against VICH, because I'm not at risk. But let it be) And 60 thousand is not superfluous to me.

Portal "Eternal youth" http://vechnayamolodost.ru23.07.2010

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