According to the announcement of the biological company Kangxinuo on the 9th in Tianjin. In the near future a clinical trial of the second phase of the 2019 recombinant coronavirus vaccine. Coronavirus Vaccine will be conducted in China and 500 volunteers will be recruited. 500 people took part in a new Phase 2 trial of a coronary pneumonia vaccine in China.
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. The one namely the middle-dose vaccine group (250 cases). The second 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 on the subjects. The research also guides the subjects to complete the safety observation and recording.
The report states that, in accordance with the requirements of the study protocol. Each subject had to undergo a study visit on the day of vaccination, 14, 28 and 6 months, which required a total of 4 blood samples.
According to the news, 108 people were enrolled in the first phase of the clinical trial. Three doses of low, medium and high vaccines were safe, and it was discovered that this vaccine could cause fever, pain at the injection site, joint pain, and other adverse reactions.
Compared to low and medium dose groups, the high dose group had a higher proportion of high temperature (body temperature above 38.5 degrees Celsius). But most recovered spontaneously within 24 hours.
According to the news in mainland China, overall, clinical trials of vaccines are often divided into three phases, and the number of subjects is increased sequentially. At the first stage of a clinical trial, the safety of the vaccine is mainly assessed and whether it can generate an immune response. At the second stage the clinical trial is used to adjust and improve clinical vaccination procedures and statistics. Such as adverse reactions, in the third phase of the clinical trial evaluated the effectiveness of the vaccine.