Russia’s Petrovax Pharm has started dosing participants in a Phase III clinical trial of Ad5-nCoV Covid-19 vaccine candidate developed by China-based CanSino Biologics and Beijing Institute of Biotechnology, Academy of Military Medical Science.
The first group of participants were vaccinated at medical centres in Moscow, in alliance with contract research organisation OCT Clinical.
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Currently, the subjects are doing well, said Petrovax. They will be monitored for the initial 28 days post vaccination and will receive four interim face-to-face examinations at treatment centres.
During this period, the vaccinated participants are expected to develop an antibody and cellular immune response to Covid-19. The subjects will then undergo a control analysis after six months.
Petrovax Pharm president Mikhail Tsyferov said: “This is an important step for us that will bring us closer to the earliest possible resolution of the coronavirus situation, not only in Russia, but throughout the world.
“Thanks to the efforts of our team and partners, we are optimistic about the continuation of a large-scale study that can offer an effective means to protect the population against Covid-19.”
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By GlobalDataThe company is enroling additional participants at other medical centres in Russia. It received approval for the Phase III trial earlier this month.
Ad5-nCoV vaccine is based on an adenoviral vector platform and carries the S-protein of the coronavirus. The vector acts as a delivery vehicle and the S-protein provides genetic information to potentially elicit an immune response.
Following registration in the Russian Federation, Petrovax expects to manufacture more than four million doses of the vaccine per month this year at its Moscow Region facilities.
Production may increase to ten million doses per month next year, owing to the planned expansion of capacity, added Petrovax.
The company will have sole rights to supply the vaccine in Russia and the CIS countries.
