According to the announcement of Tianjin-based Kangxinuo Biological Company on the 9th, a phase 2 clinical trial of the recombinant 2019 coronavirus vaccine (adenovirus vector) will be conducted in China in the near future, and 500 volunteers will be recruited.
According to a report by the Central News Agency today, China ’s new coronary pneumonia vaccine phase 2 trial recruited 500 subjects.
The news quoted the People's Daily Health APP today saying that unlike the first phase of the trial, this time the study was larger and a placebo control group was introduced. The study was divided into three groups, namely the middle-dose vaccine group (250 cases), the low-dose vaccine group (125 cases) and the placebo control group (125 cases). According to the report, participants in the Phase 2 vaccine trial do not need to receive 14 days of concentrated observation, and can complete the safety observation by themselves. During this period, the research team will send special personnel to follow up the subjects and guide the subjects to complete the safety observation and recording.
The report said that in accordance with the requirements of the study protocol, each subject had to complete a study visit on the day of vaccination, 14th, 28th, and 6th month, requiring a total of 4 blood collections.
According to the news, a total of 108 people were enrolled in the first phase of the clinical trial. The safety of the three doses of low, medium and high vaccines was observed. It was found that this vaccine may cause fever, pain at the vaccination site, joint pain and other adverse effects. reaction. Compared with the low- and middle-dose groups, the high-dose group had a higher proportion of high fever (body temperature higher than 38.5 degrees Celsius), but most recovered spontaneously within 24 hours.
Central News Agency said that according to news in mainland China, in general, clinical studies of vaccines are often divided into three phases, and the number of subjects increases sequentially. The first-phase clinical study mainly evaluates the safety of the vaccine and whether it can generate an immune response; the second-phase clinical study is used to adjust and improve the procedures and procedures of clinical vaccination and obtain statistical data such as adverse reactions; the third-phase clinical study mainly evaluates The effectiveness of the vaccine.