China’s CanSino Biologics Begins Final Phase of Human Trials of COVID-19 Vaccine in Saudi Arabia
By HospiMedica International staff writers Posted on 12 Aug 2020 |
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CanSino Biologics Inc. (Tianjin, China) has begun conducting Phase 3 trials of its COVID-19 vaccine in Saudi Arabia, after completing the first two phases of the human trials in China.
CanSino’s vaccine, called Ad5-nCOV, which has been developed in collaboration with China’s military research unit, uses a harmless cold virus known as adenovirus type-5 (Ad5) to carry genetic material from the coronavirus into the body. Phase 1 of the study involved testing three different doses (low, medium, and high) of the vaccine on 108 volunteers, while Phase 2 involved testing two different doses (low and medium) of the vaccine on 603 volunteers in China. In both the studies, the vaccine successfully generated COVID-19 antibodies in the volunteers' plasma and good immune responses, along with only a few side effects, especially with low vaccine doses.
Following confirmation of the vaccine’s effectiveness and safety of the vaccine in Phase 1 and 2, Phase 3 will involve multi-center clinical studies in several countries and a large number of volunteers. The Phase 3 study in Saudi Arabia will involve a minimum of 5,000 healthy participants above the age of 18 years who will be divided into two groups. The first group will be administered a low dose of the vaccine while the second group will be given the vaccine without any active ingredients. Researchers will check on the participants after they are given the vaccine to monitor any possible side effects by conducting immunological tests and using electronic follow-up methods.
Related Links:
CanSino Biologics Inc.
CanSino’s vaccine, called Ad5-nCOV, which has been developed in collaboration with China’s military research unit, uses a harmless cold virus known as adenovirus type-5 (Ad5) to carry genetic material from the coronavirus into the body. Phase 1 of the study involved testing three different doses (low, medium, and high) of the vaccine on 108 volunteers, while Phase 2 involved testing two different doses (low and medium) of the vaccine on 603 volunteers in China. In both the studies, the vaccine successfully generated COVID-19 antibodies in the volunteers' plasma and good immune responses, along with only a few side effects, especially with low vaccine doses.
Following confirmation of the vaccine’s effectiveness and safety of the vaccine in Phase 1 and 2, Phase 3 will involve multi-center clinical studies in several countries and a large number of volunteers. The Phase 3 study in Saudi Arabia will involve a minimum of 5,000 healthy participants above the age of 18 years who will be divided into two groups. The first group will be administered a low dose of the vaccine while the second group will be given the vaccine without any active ingredients. Researchers will check on the participants after they are given the vaccine to monitor any possible side effects by conducting immunological tests and using electronic follow-up methods.
Related Links:
CanSino Biologics Inc.
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