Some 92.5% of Russian volunteers in Chinese coronavirus vaccine trials develop high antibody titer - Petrovax
MOSCOW. Jan 14 (Interfax) - Intermediate results of the third stage of clinical trials of the Chinese coronavirus vaccine Ad5-nCov indicate that 92.5% of Russian volunteers have developed a high antibody titer and there are no adverse side effects, a representative of the Petrovax company told Interfax on Thursday.
"Intermediate results of the local clinical trials of the third stage indicate a high level of safety and efficacy of the Ad5-nCoV (Convidicea) vaccine. Data from 200 out of 500 vaccinated volunteers has been analyzed and the efficacy measurement shows that 92.5% of volunteers developed a high titer of Covid-19 antibodies," the company press service said.
"No adverse side effects or dropouts from the trials caused by the development of adverse reactions have been registered in the analyzed period," it said.
According to the company, 34.2% of volunteers reported such post-vaccination reactions as a slight fever, a headache, muscle and joint pain, and fatigue, which passed within the first few days.
"Similar reactions were observed in 16% of volunteers who received the placebo," the press service said.
"In furtherance of the local trials, the volunteers will remain under observation for six months after vaccination. Final results of the trials will become available in the middle of 2021," it said.
The first stage of a local clinical trial of the third phase of the candidate vaccine Ad5-nCov began in Russia in August. Volunteers received the vaccine at eight institutions in Moscow, St. Petersburg, Yaroslavl, and Yekaterinburg since September.
It was reported in December that the Russian Health Ministry had allowed the start of the third international stage of clinical trials of the Ad5-nCov vaccine manufactured by CanSino Biologics (CanSinoBIO).
The clinical trials are expected to involve 8,000 volunteers from Russia. The first groups of volunteers participating in the international stage of clinical trials have already been vaccinated. In all, the trials will involve over 40,000 volunteers aged 18 and up. Results of the vaccination will be analyzed by an international group of scientists.
According to Petrovax, the main goal of the international trials is to confirm the efficacy of the Ad5-nCoV vaccine in the prevention of any forms of severity of Covid-19 cases during 12 months after the vaccination date. The frequency of Covid-19 cases in the group vaccinated with Ad5-nCoV will be compared to that in the control group.
Another important task in the evaluation of the vaccine's safety is the frequency of adverse side effects that might be developed by any subjects over the next 12 months.
Once the vaccine is registered in the Russian territory, Petrovax will be ready to begin its production at the company plant in the Moscow region, which holds Russian and international GMP certificates.
The first stage of clinical trials of CanSino Biologics' coronavirus vaccine began in China in March and involved 108 volunteers. The second stage took place in Wuhan and involved 508 volunteers. Results of the two stages were published in The Lancet peer-reviewed medical journal. According to the report, the Ad5 vector vaccine is safe and induces a substantial humoral and cell immune response in most vaccinated persons after they receive one dose of the vaccine.