摘要
目的评估在应急情况下疫苗临床试验受试者招募的新方法。方法通过网站和自媒体等在武汉局部地区发布招募通知,引导有意向者登录“新冠疫苗临床试验预约登记和健康主动申报系统”(简称主动申报系统)进行预约登记和健康主动申报,主动申报系统对每名志愿者进行评估并划分风险等级以初步排除不符合纳入标准的志愿者,研究者对初评合格的志愿者进行电话回访,组织志愿者前往疫苗接种现场,最后进行入组前的严格体检筛查以确定最终受试者。结果Ⅰ和Ⅱ期招募系统分别共登记4819和5132名,男性2912(60.43%)和2887名(56.25%),多于女性的1907(39.57%)和2245名(43.75%),均以20~39岁年龄段居多,分别有3211(66.63%)和3966名(77.28%);武汉13个区均有居民意向参与临床研究,Ⅱ期招募系统初步通过人数高于Ⅰ期,男性通过人数2047(70.28%)和2135名(73.95%),高于女性1083(56.80%)和1472名(65.57%);Ⅰ和Ⅱ期分别电话回访440和689名,电话确认参加人数约154(35.00%)、463名(67.20%);到达疫苗接种现场志愿者分别有201和603名,新冠病毒抗体阳性分别有12和26例,抗体阳性率为6.00%和4.31%。结论本研究受试者招募的新方法高效、可靠,Ⅰ期的招募情况为Ⅱ期做了良好的典范,但受试者的中长期依从性以及出现的意愿与行为分离的情况仍需进一步研究。
Objective To evaluate and share the novel method for recruiting participants in clinical trials of vaccines in emergency situations.Methods 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.Results A total of 4819 people and 5132 people registered in the PhaseⅠand PhaseⅡrecruitment system respectively,with men 2912(60.43%)and 2887(56.25%)more than women 1907(39.57%)and 2245(43.75%),mostly in the 20‑39 age group,with 3211(66.63%)and 3966(77.28%).All 13 districts in Wuhan have interested residents to participate clinical research.The initial qualified rate of the PhaseⅡrecruitment system was higher than that of PhaseⅠ,with men 2047(70.28%)and 2135(73.95%),higher than women 1083(56.80%)and 1472(65.57%);440 and 689 people were reviewed by telephone in PhaseⅠand PhaseⅡrespectively,and the number of verified volunteers was about 440(35.00%)and 689(67.20%);Of the 201603 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.Conclusion The novel method for recruiting subjects in this clinical study is efficient and reliable,and the recruitment situation of PhaseⅠhad set a good example for PhaseⅡbut the medium‑and long‑term compliance of subjects and the separation of willingness and behaviors still need to be further studied.
作者
江湖大川
王兆
王雷
王文娟
王虎
邓鹏
贾斯月
刘朝华
朱凤才
Jiang Hudachuan;Wang Zhao;Wang Lei;Wang Wenjuan;Wang Hu;Deng Peng;Jia Siyue;Liu Zhaohua;Zhu Fengcai(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;Department of Vaccine Clinical Evaluation,Jiangsu Provincial Center for Disease Control and Prevention,Nanjing 210009,China;The Discipline and Platform Construction Office,Zhongnan Hospital of Wuhan University,Wuhan 430000,China;Wuhan Special Service recuperation Center of the Chinese People′s Armed Police Force,Wuhan 430070,China)
出处
《中华预防医学杂志》
CAS
CSCD
北大核心
2020年第9期963-967,共5页
Chinese Journal of Preventive Medicine
关键词
疫苗
临床试验
招募系统
健康申报
电话回访
Vaccines
Clinical trial
Recruitment system
Health declaration
Telephone interviews
