Implementing a Multisite Clinical Trial in the Midst of an Ebola Outbreak: Lessons Learned From the Sierra Leone Trial to Introduce a Vaccine Against Ebola
Implementing a Multisite Clinical Trial in the Midst of an Ebola Outbreak: Lessons Learned From the Sierra Leone Trial to Introduce a Vaccine Against Ebola
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DOI：
10.1093/infdis/jix657
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发表时间：
2018-06-15
影响因子：
6.4
通讯作者：
Seward, Jane F.
中科院分区：
文献类型：
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作者：
Carter, Rosalind J.;Idriss, Ayesha;Seward, Jane F.
塞拉利昂推出抗埃博拉疫苗试验 (STRIVE) 是研究性 rVSV Delta G-ZEBOV-GP 疫苗的 2/3 期试验，是在史无前例的埃博拉疫情期间进行的。超过 8600 名符合条件的医疗保健和一线响应人员被单独随机分配到立即（7 天内）或推迟（18-24 周内）接种疫苗，并在接种疫苗后针对严重不良事件和埃博拉病毒感染进行为期 6 个月的随访。主要挑战包括支持试验活动的基础设施有限、电力不可靠以及临床试验经验有限的工作人员。研究人员进行了大量基础设施投资，包括翻新招募地点、实验室和政府冷链设施，以及进口设备来储存和运输 350 名员工的疫苗，并通过每日审查和反馈会议得到加强。通过向参与者发放移动电话、进行家访以及设立护士分诊热线，解决了安全随访的操作挑战。在埃博拉疫情爆发之前，塞拉利昂进行临床试验的基础设施和人员有限。在不干扰疫情应对的情况下，STRIVE 响应了紧急需求并帮助建立了这种能力。
The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE), a phase 2/3 trial of investigational rVSV Delta G-ZEBOV-GP vaccine, was conducted during an unprecedented Ebola epidemic. More than 8600 eligible healthcare and frontline response workers were individually randomized to immediate (within 7 days) or deferred (within 18-24 weeks) vaccination and followed for 6 months after vaccination for serious adverse events and Ebola virus infection. Key challenges included limited infrastructure to support trial activities, unreliable electricity, and staff with limited clinical trial experience. Study staff made substantial infrastructure investments, including renovation of enrollment sites, laboratories, and government cold chain facilities, and imported equipment to store and transport vaccine at 350 staff, which was reinforced with daily review and feedback meetings. The operational challenges of safety follow-up were addressed by issuing mobile telephones to participants, making home visits, and establishing a nurse triage hotline. Before the Ebola outbreak, Sierra Leone had limited infrastructure and staff to conduct clinical trials. Without interfering with the outbreak response, STRIVE responded to an urgent need and helped build this capacity.