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OCT Clinical contracted to perform a full scope of trial services for the Ad5-nCoV, co-developed by CanSinoBIO and BIB.
FREMONT, CA: OCT Clinical, a pioneering European CRO, announces that 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 and Beijing Institute of Biotechnology, Academy of Military Medical Science. In November, the Ministry of Health of Russia has approved Petrovax Pharm, a Russian biopharmaceutical firm, to conduct a comprehensive international, multicenter, placebo-based phase III trial on behalf of CanSinoBIO.
The international study's enrollment target is 40,000 volunteers over 18 years old, 8,000 of which will be recruited in Russia. OCT Clinical is responsible for activities in Russia, including regulatory and logistics assistance, project management, volunteer recruitment, and monitoring. Despite the hurdles coming from the newly imposed sanitary and epidemiological constraints at medical facilities, the study is undergoing smoothly. All activities are performed in strict accordance with the protocol. A keen interest is expressed by the general population, several of whom approach the firm directly, willing to participate in the study.
More than 1,5 thousand volunteers have been enrolled in the study. The first subjects have already been successfully vaccinated, with the rest ready to receive a single dose of the vaccine candidate within the coming months. The IM administered vaccine is being analyzed in research sites across different Russian cities, 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 identify possible adverse events. The outcomes 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 low-grade fever the day after vaccination. 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 released the local stage of phase III clinical study of the Ad5-nCov vaccine candidate in Russia, with 500 volunteers vaccinated.