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Russia has granted approval for a Phase III clinical trial of China-based CanSino Biologics’ Covid-19 vaccine candidate, developed in alliance with the Chinese military’s research arm.
The Phase III trial of the Ad5-nCoV vaccine candidate has been launched in Moscow, following health ministry authorisation. CanSino will work with NPO Petrovax Pharm to conduct the trials in Russia.
A statement from the CanSino said: “The company is currently driving the international multi-centre phase three clinical trial for Ad5-nCoV and plans to conduct the clinical trial for Ad5-nCoV in several countries.”
The Russian approval comes after CanSino and the National Research Council (NRC) of Canada terminated their collaboration on the development of the vaccine.
Trials in Canada were expected to start in July but were cancelled after failing to receive vaccine shipments from China.
CanSino plans to test its vaccine candidate in multiple countries globally. The company expects to enrol a total of approximately 40,000 participants.
Last month, the company announced plans to initiate a Phase III trial of Ad5-nCOV in Saudi Arabia. This trial is set to enrol about 5,000 subjects.
The vaccine candidate is made up of a harmless cold virus known as adenovirus type-5 (Ad5) to deliver genetic material from the coronavirus into the body.
Data from previous trials showed that the candidate was safe and triggered immune responses in most participants. CanSino conducted the first and second phase studies of Ad5-nCoV in China.
The first phase evaluated three different doses of the vaccine in 108 volunteers in China from 16 to 27 March while the second phase tested two doses in 603 subjects from 11 to 16 April.
Results revealed a favourable efficiency profile, with Covid-19 antibodies observed in the plasma of the participants. Few side effects were reported, primarily with low vaccine doses.