Recruitment of Volunteers for Phase II Clinical Trial of New Coronavirus Vaccine
Science and Technology Daily, Beijing, April 9 (Reporter Zhang Gailun) On the 9th, according to volunteers who participated in the phase I clinical trial of the recombinant new coronavirus vaccine (adenovirus vector), the recruitment of volunteers for the phase II clinical trial of the vaccine has been revealed. The trial plan recruits 500 people and will introduce a placebo control group.
Over the past 20 days, 108 volunteers in the Phase I clinical trial have been vaccinated successively, and have received 14 days of intensive care observation as required by the trial. On the 9th, the last batch of volunteers had ended their isolation. It is understood that everyone is in good health.
The phase Ⅰ clinical study observed the safety of the three vaccine doses of low, medium and high, and found that this vaccine may cause adverse reactions such as fever, pain at the vaccination site, and joint pain. Compared with the low- and middle-dose groups, the high-dose group had a higher proportion of high fever (body temperature ≥ 38.5 ° C), but recovered more frequently within 24 hours.
The Phase II clinical study finally selected low and medium doses. The study was conducted in 3 groups, namely the middle-dose vaccine group (250 cases), the low-dose vaccine group (125 cases) and the placebo control group (125 cases). In other words, volunteers have a 50% chance of getting a medium-dose vaccine (1 ml), a 25% chance of getting a low-dose vaccine (0.5 ml), and a 25% chance of getting a placebo control.
This time, the volunteers do not need to receive 14 days of intensive convalescence observation, and can complete the safety observation by themselves. During this period, the research team will send someone to follow up the volunteers and guide them to complete the safety observation and recording.
During the safety observation period, if an adverse event occurs, volunteers can get timely treatment. The research team also bought commercial insurance for volunteers. Each volunteer must cooperate to complete a study visit on the day of inoculation, 14th, 28th and 6th month. A total of 4 blood collections are required.
In general, clinical studies of vaccines are often divided into phases I, II, and III. 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 the Phase II clinical study was moderate to adjust and improve the clinical vaccination procedures and procedures and obtain adverse reactions And other statistical data; Phase III clinical studies mainly evaluate the effectiveness of the vaccine and recruit large-scale subjects to confirm that the vaccine can achieve the desired purpose of preventing infection or reducing symptoms.