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OCT Clinical contracted to run a full scope of trial services for the Ad5-nCoV vaccine candidate, co-developed by CanSinoBIO and BIB, has reported on the progress of the study and the interim results of the vaccination in Russia.
ST. PETERSBURG, RUSSIA, December 29, 2020 /EINPresswire.com/ -- OCT Clinical, a leading European CRO headquartered in Russia, today announced it has been appointed for a full range of clinical trial services in 8,000 healthy volunteers for the Ad5-nCoV vaccine candidate, co-developed by CanSino Biologics Inc. (“CanSinoBIO”) (SHSE: 688185, HKEX:06185) and Beijing Institute of Biotechnology, Academy of Military Medical Science (BIB). In November, the Ministry of Health of Russia granted approval to Petrovax Pharm, a Russian biopharmaceutical company, to conduct a comprehensive international, multicenter, placebo-controlled phase III trial on behalf of CanSinoBIO.
The overall enrollment target for the international study is 40,000 volunteers over 18 years old, 8,000 of which will be recruited in Russia. OCT Clinical is responsible for a full range of activities in Russia, including regulatory and logistics support, project management, volunteer recruitment and monitoring.
"Despite the challenges coming from the newly imposed sanitary and epidemiological constraints at medical facilities, the study is running smoothly, and all activities are being carried out in strict accordance with the protocol. We have not seen any difficulties in recruiting volunteers either. Moreover, we observe a genuine interest expressed by the general population, many of whom approach us directly, willing to participate in the study,” commented Dmitry Lioznov, M.D., the Head of the A.A. Smorodintsev Research Institute of Influenza, and a chief co-investigator of the multinational vaccine study in Russia.
More than 1,5 thousand volunteers have been already enrolled in the study so far. The first groups of subjects have already been successfully vaccinated, with the rest set to receive a single dose of the vaccine candidate within the coming months. The IM administered vaccine is being studied in research sites across several cities in Russia, including Moscow, St. Petersburg, Yaroslavl, Perm, Saratov, Omsk, Murmansk, Novosibirsk, Chita.
The vaccine is administered in a single dose. After the vaccination, the volunteers will be monitored for 12 months to detect possible adverse events. The results will be analyzed by an international team of scientists, comparing the incidence rate of Covid-19 in the Ad5-nCoV vaccine group with that of the control group. The research sites report that all volunteers tolerate the vaccine well. A small number had a single low grade fever the day after vaccination, which would normally go away on its own or be easily treated with paracetamol. No serious adverse events or other abnormalities have been detected in any of the volunteers so far.
In August of 2020, OCT Clinical and Petrovax Pharm launched the local stage of the phase III clinical study of the Ad5-nCov vaccine candidate in Russia, with 500 volunteers vaccinated as a result.
"We all have been working hard to ensure the widest possible vaccination coverage for our population,” said Dmitry Sharov, President, OCT Clinical. “The phase three clinical study is a key step in a comprehensive program to assess the safety and efficacy of the vaccine candidate against Covid-19.”