Volunteers recruited for Phase II clinical study of New Crown Vaccine: require Hubei Health "green code"
Surging news reporter Wang Xin
On April 9, the first batch of volunteers vaccinated with the recombinant new crown vaccine shared the news through the circle of friends that the phase II clinical study of the recombinant new coronavirus vaccine (adenovirus vector) is recruiting volunteers. The study plan recruits healthy adults 18 years of age and older, holds the Hubei Health Code "green code", has no history of vaccination allergies, no history of new coronary pneumonia or infection, and can consistently complete 6 months of study follow-up.
Surging News (www.thepaper.cn) clicks on the "Recombination New Crown Vaccine Clinical Research Appointment Registration QR Code" and enters the login interface. After clicking "Register Account", the page automatically pops up information about recruiting volunteers. After entering the "Appointment Registration and Active Health Declaration System", you need to fill in information such as name, ID number, area and street, current address, mobile phone number, login password and other information. The reporter noticed that the region of choice is limited to 13 districts in Wuhan.
After clicking "Next", a "Informed Consent Form" will pop up on the page.
"Informed Consent" describes the use of the recombinant coronavirus vaccine (adenoviral vector) and placebo control used in the study by the Institute of Military Medical Sciences, Academy of Military Sciences, Institute of Bioengineering and Kang Xinuo Biological Co., Ltd.
"Informed Consent" showed that the study was divided into three groups, namely the middle-dose vaccine group (250 cases), low-dose vaccine group (125 cases) and placebo control group (125 cases), a total of 500 cases. As a volunteer, you will have a 50% chance of getting a medium-dose vaccine, a 25% chance of getting a low-dose vaccine, and a 25% chance of getting a placebo control.
According to the requirements of the research protocol, each volunteer completed a study visit on the day of inoculation, 14th, 28th and 6th month, a total of 4 visits. It takes approximately 6 months to complete the entire study. Among them, on the day of vaccination, researchers will carry out relevant examinations for volunteers, including screening of new coronavirus antibodies and HIV antibodies, height, weight, blood pressure and armpit temperature measurement, etc .; 30 minutes to 14 days after vaccination, volunteering Those who have completed their own safety observations. During this period, the researcher will send a person to follow up the volunteers every day to guide the volunteers to complete the safety observation and recording; from the 15th day to the 28th day after the inoculation, the researcher will send the volunteer a "diary card". Observe and record all adverse reaction symptoms, health status, medical history, medication and other vaccine usage as required; on the 28th day after vaccination, the researchers will interview the volunteers to review the record of the "diary card".
The "Informed Consent Form" stated that to thank the volunteers for their contribution to the prevention and control of the new type of coronary ice pneumonia, and to compensate the volunteers for their contributions (including nutrition fees, transportation subsidies, etc.) and risks they took in the study process The researchers will give each volunteer 500 yuan in cash compensation after each blood collection visit.
Surging News previously reported that since arriving in Wuhan on January 26, a scientific research team led by Chen Wei, an academician of the Chinese Academy of Engineering and a researcher at the Academy of Military Medical Sciences of the Academy of Military Sciences, has concentrated its efforts on emergency research in vaccine development. On March 16, the recombinant new crown vaccine developed by the academician Chen Wei team passed the clinical research registration review; at 20:18 on the same day, it was approved to enter the clinical trial. The first batch of 108 volunteers have been vaccinated successively since March 16. Subsequently, they were arranged to stay in the Wuhan Special Service Rehabilitation Center for centralized isolation and observation. From March 31st, the first batch of volunteers ended their concentrated isolation observation and returned home. These volunteers will also collect blood samples on the 28th, 3rd, and 6th months after vaccination.