Results of tests of the Russian vaccine against COVID-19 published

The Lancet journal published the official results of the first two phases of trials of the Russian Sputnik V vaccine, developed by the National Center for Epidemiology and Microbiology named after N.F. Gamaleya. Preliminary data shows that the vaccine produces a good antibody response and does not cause serious side effects. Writes about this RIA News".

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The trials lasted 42 days and consisted of two phases, each of which involved 38 healthy adult volunteers. At the first stage, the components of the candidate vaccine were tested for safety, at the second stage, it was determined whether the vaccine would induce the required immune response.

The Sputnik V vaccine is a two-component vaccine. It includes two adenoviral vectors, recombinant human adenovirus type 26 (rAd26-S) and recombinant human adenovirus type 5 (rAd5-S), which have been modified to express the SARS-CoV-2 spike protein. These types of recombinant adenoviral vectors have been used for a long time, their safety has been confirmed in many clinical studies. The adenoviruses in them are weakened and cannot replicate in human cells.

The vaccine is aimed at stimulating both parts of the immune system - antibodies that attack the virus itself, and T cells that target infected cells.

Volunteers were given rAd26-S first, and rAd21-S after 5 days. At the same time, two types of vaccine were tested - frozen and freeze-dried. The second option, dehydrated and vacuum dried, is intended for hard-to-reach regions where it is not always possible to store frozen material.

On the subject: COVID-19 vaccine: how to become a volunteer and take part in trials

The publisher's press release contains the words of the lead author of the study, Denis Logunov from N.F. Gamaleya, who explains why they used two different adenovirus vectors: “When adenovirus vaccines enter human cells, they deliver the genetic code for the SARS-CoV-2 spike protein, which causes the cells to produce the spike protein. This trains the immune system to recognize the virus and attack it. To mount a strong immune response against SARS-CoV-2, booster vaccination is important. However, booster vaccinations using the same adenoviral vector may not produce an effective response because the immune system will block the vaccine from entering people's cells. For our vaccine, we use two different adenoviral vectors to ensure that the immune system does not become immune to the vector.”

Thus, the use of various adenoviral vectors provides a stable immune response and, at the same time, avoids an immune response to the first viral vector.

The trials took place in two hospitals in Russia, they were open and non-randomized, that is, the participants knew that they were receiving the vaccine and were not randomly assigned to groups.

The studies involved healthy adults between the ages of 18 and 60 who self-isolated as soon as the trial began and remained in the hospital for 28 days after the first vaccination. All volunteers provided their written consent.

Phase 21 trials have shown that both two-part vaccine formulations have a good safety profile without any serious side effects. Within 28 days, all participants developed antibodies, and within XNUMX days, a T-cell response.

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Scientists have compared these results to immune responses in people who have had COVID-19. It turned out that the vaccinated had a higher level of antibodies than those who had recovered. In addition, neutralizing antibodies against rAd26 did not interfere with rAd5 and vice versa. The researchers believe this confirms the effectiveness of their chosen strategy of using two adenoviral vectors, but note that additional trials are needed for definitive conclusions.

“Unprecedented measures have been taken to develop a vaccine against COVID-19 in Russia. Preclinical and clinical studies were carried out, which allowed the preliminary approval of the vaccine in accordance with the current Decree of the Government of the Russian Federation dated April 3, 2020 No. 441, says academician Alexander Ginzburg, director of the N.F. Gamaleya. “Temporary licensing allows the vaccine to be used under strict pharmacovigilance and ensure vaccination of risk groups.”

Phase 3 clinical trials were approved on August 26, 2020. It is planned that 40 thousand volunteers from different age groups and risk groups will take part in it. Its results will be tracked through an online application.

As ForumDaily wrote earlier:

• On August 11, Russia announced the readiness of the world's first vaccine against coronavirus.
• The US reacted with suspicion to the Russian vaccine against coronavirus and refused to cooperate.

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