China-based CanSino Biologics announced on April 9 that its recombinant new coronavirus vaccine (adenoviral vector) is planning to conduct a phase II clinical trial in China in the near future based on preliminary safety data from the phase I clinical trial.
According to the announcement, according to the preliminary safety data of the phase I clinical trial of the recombinant new coronavirus vaccine (adenoviral vector) ("Ad5-nCoV"), the company and the Institute of Bioengineering, Academy of Military Medical Sciences, Academy of Military Sciences plan to launch Ad5- Phase II clinical trial of nCoV.
Ad5-nCoV is constructed using genetic engineering methods and uses replication-deficient human adenovirus type 5 as a vector to express new coronavirus S antigens. It is intended to prevent diseases caused by new coronavirus infections.
On March 17, CanSino issued an announcement that the recombinant new coronavirus vaccine (adenovirus vector) submitted an application for pre-review of I clinical trials and started pre-recruitment of healthy volunteers.
In the Phase I clinical trial, 108 volunteers of different ages were successively vaccinated with recombinant new coronavirus vaccine (adenovirus vector)
According to industry sources, in general, clinical studies of vaccines are often divided into phases I, II, and III, and the number of subjects increases sequentially.
The Phase I clinical study recruited a small number of subjects to evaluate the safety of the vaccine and whether it could produce an immune response.
The number of subjects in Phase II clinical research is moderate, to adjust and improve the procedures and procedures of clinical vaccination, and to obtain statistical data such as adverse reactions.
The phase III clinical study mainly evaluates the effectiveness of the vaccine and recruits large-scale subjects to confirm that the vaccine can achieve the intended purpose of preventing infection or reducing symptoms.
Earlier, Wu Zunyou, chief expert in epidemiology of the Chinese Center for Disease Control and Prevention, had stated that even if it was handled according to special circumstances, the vaccine would have to undergo a phase III clinical trial. According to the shortest time, the clinical phase I should be no less than 20 days.
The second phase of the clinical trial will test the procedures and procedures for clinical vaccination. It will take about 200 to 300 people, and the shortest time for recruitment to complete is one month.
The Phase III clinical trial is to evaluate the effectiveness of the vaccine. If the phase III clinical trial is completed, it is concluded that the vaccine is effective, and the shortest time is six months.
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