Jiang H D C, Wang Z, Wang L, Wang W J, Wang H, Deng P, Jia S Y, Liu Z H, Zhu F C
School of Public Health, Southeast University, Nanjing 210009, China.
Institute of Infectious Disease Control and Prevention, Hubei Center for Disease Control and Prevention, Wuhan 430070, China.
Zhonghua Yu Fang Yi Xue Za Zhi. 2020 Sep 6;54(9):963-967. doi: 10.3760/cma.j.cn112150-20200427-00653.
To evaluate and share the novel method for recruiting participants in clinical trials of vaccines in emergency situations. To publish recruitment notice in local areas of Wuhan through websites and medium, and guide interested persons to log in to the"Clinical Trials of SARS-CoV-2 Vaccine Reservation and Health Declaration System"to appoint and register their health information. The "Health Declaration System" provides each volunteer evaluation and risk levels to preliminarily exclude those who do not meet the inclusion criteria. Researchers review the qualified volunteers by telephone, organize them to go to the vaccination site, and finally conduct a strict medical screening to determine the final subjects. A total of 4 819 people and 5 132 people registered in the Phase Ⅰ and Phase Ⅱ recruitment system respectively, with men 2 912 (60.43%) and 2 887 (56.25%) more than women 1 907 (39.57%) and 2 245 (43.75%), mostly in the 20-39 age group, with 3 211 (66.63%) and 3 966 (77.28%). All 13 districts in Wuhan have interested residents to participate clinical research.The initial qualified rate of the Phase Ⅱ recruitment system was higher than that of Phase Ⅰ, with men 2 047 (70.28%) and 2 135(73.95%), higher than women 1 083 (56.80%) and 1 472 (65.57%); 440 and 689 people were reviewed by telephone in Phase Ⅰ and Phase Ⅱ respectively, and the number of verified volunteers was about 440 (35.00%) and 689 (67.20%); Of the 201 603 people who arrived at the vaccination site, 12 and 26 of them were positive for the SARS-CoV-2 antibody with an antibody positive rate of 6.00% and 4.31% respectively. The novel method for recruiting subjects in this clinical study is efficient and reliable, and the recruitment situation of Phase Ⅰ had set a good example for Phase Ⅱ but the medium-and long-term compliance of subjects and the separation of willingness and behaviors still need to be further studied.
评估并分享在紧急情况下为疫苗临床试验招募参与者的新方法。通过网站和媒体在武汉当地发布招募通知，引导感兴趣的人员登录“新冠病毒疫苗预约及健康申报系统”预约并登记健康信息。“健康申报系统”为每位志愿者提供评估和风险等级，初步排除不符合纳入标准的人员。研究人员通过电话对合格志愿者进行审核，组织他们前往接种点，最后进行严格的医学筛查以确定最终受试者。Ⅰ期和Ⅱ期招募系统分别有4819人和5132人注册，男性分别为2912人（60.43%）和2887人（56.25%），多于女性1907人（39.57%）和2245人（43.75%），大多在20 - 39岁年龄组，分别为3211人（66.63%）和3966人（77.28%）。武汉所有13个区均有感兴趣的居民参与临床研究。Ⅱ期招募系统的初始合格率高于Ⅰ期，男性分别为2047人（70.28%）和2135人（73.95%），高于女性1083人（56.80%）和1472人（65.57%）；Ⅰ期和Ⅱ期分别有440人和689人通过电话审核，核实的志愿者人数约为440人（35.00%）和689人（67.20%）；到达接种点的201603人中，分别有12人和26人新冠病毒抗体呈阳性，抗体阳性率分别为6.00%和4.31%。本临床研究招募受试者的新方法高效可靠，Ⅰ期的招募情况为Ⅱ期树立了良好榜样，但受试者的中长期依从性以及意愿与行为的分离仍需进一步研究。
