The Ministry of health of then Federation issued a permit for the holding in our country of the third phase of clinical trials of adenovirus vaccine COVID-19, created by a Chinese company CanSino and Biologics already approved for limited use by the Chinese military. A corresponding entry is published in the state register of clinical trials. In it is planned to involve 625 volunteers, in addition, the third phase will be held in China, Saudi Arabia, Canada and several other countries — all with the participation of more than 30 thousand people, said N+1 representative of the company “Petrovax farm” which holds then part of the test.
Earlier in our country was registered vaccine COVID-19, was developed in the Center of Gamaliel. She, like the development of CanSino Biologics based on the use of viral vector is a recombinant adenovirus, which is deprived of the ability to reproduce, and in gene “inserted” sequence coding for the S protein of coronavirus. Getting into the cells of the body, the virus causes them to produce coronavirus protein that generates an immune response. The vaccine center of a name of Gamalei used two different types of adenovirus Ad5 and Ad26, which requires two injections. In the Ad5 vaccine-nCov created CanSino Biologics, there is only one vector Ad5 and need one injection.
Clinical trials of Ad5-nCov Chinese developers began in March 2020. In the first phase was attended by 108 volunteers, the second — 508, 126 of them received placebos, the rest of the vaccine. And the first and second phases were conducted in China. The results were described in an article published in August in the journal Lancet. According to these data, most of the subjects formed a pronounced immune response. Even before the article, at the end of June, the Central military Council of China issued an annual permit to use
vaccine Ad5-nCov for the military.
Now, in our country launched a phase three trial: a multicenter, randomized, double-blind, placebo-controlled study to assess the effectiveness, reactogenicity and safety of the vaccine, Ad5-nCoV will be held with the participation of 625 adult volunteers aged 18 to 85 years. The recruitment of volunteers, initial medical examination and the vaccination will be held in eight centres located in Moscow, St.-Petersburg, Ekaterinburg and Yaroslavl. The term of a permit to test will expire on 31 July 2021.
The company “Petrovax” developed a test Protocol organizes incoming inspection and release of the drug, the recruitment of volunteers and monitoring, laboratory diagnosis and analysis of the data. In the future, the company hopes to establish Chinese production of the vaccine.
Adenovirus vaccine against the new coronavirus infection to develop and other organizations, in particular, the company Johnson & Johnson and Oxford University. What other versions of vaccines against coronavirus infection developed in our country and in the world, read our article “On the tip of the needle”.