拉沙热疫苗候选物：疫苗临床试验的范围综述。
Lassa fever vaccine candidates: A scoping review of vaccine clinical trials.
机构信息
School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Canada.
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
出版信息
Trop Med Int Health. 2023 Jun;28(6):420-431. doi: 10.1111/tmi.13876. Epub 2023 Apr 24.
OBJECTIVE
Lassa fever (LF) is caused by a viral pathogen with pandemic potential. LF vaccines have the potential to prevent significant disease in individuals at risk of infection, but no such vaccine has been licensed or authorised for use thus far. We conducted a scoping review to identify and compare registered phase 1, 2 or 3 clinical trials of LF vaccine candidates, and appraise the current trajectory of LF vaccine development.
METHOD
We systematically searched 24 trial registries, PubMed, relevant conference abstracts and additional grey literature sources up to 27 October 2022. After extracting key details about each vaccine candidate and each eligible trial, we qualitatively synthesised the evidence.
RESULTS
We found that four LF vaccine candidates (INO-4500, MV-LASV, rVSV∆G-LASV-GPC, and EBS-LASV) have entered the clinical stage of assessment. Five phase 1 trials (all focused on healthy adults) and one phase 2 trial (involving a broader age group from 18 months to 70 years) evaluating one of these vaccines have been registered to date. Here, we describe the characteristics of each vaccine candidate and trial and compare them to WHO's target product profile for Lassa vaccines.
CONCLUSION
Though LF vaccine development is still in early stages, current progress towards a safe and effective vaccine is encouraging.
目的
拉沙热（LF）是由一种具有大流行潜力的病毒病原体引起的。LF 疫苗有可能预防感染风险人群的重大疾病，但迄今为止，尚无此类疫苗获得许可或授权使用。我们进行了范围界定审查，以确定和比较 LF 疫苗候选物的已注册 1 期、2 期或 3 期临床试验，并评估 LF 疫苗开发的当前轨迹。
方法
我们系统地搜索了 24 个试验登记处、PubMed、相关会议摘要和其他灰色文献来源，截至 2022 年 10 月 27 日。在提取每个候选疫苗和每个合格试验的关键细节后，我们对证据进行了定性综合。
结果
我们发现有四种 LF 疫苗候选物（INO-4500、MV-LASV、rVSV∆G-LASV-GPC 和 EBS-LASV）已进入评估的临床阶段。迄今为止，已登记了五项 1 期试验（均针对健康成年人）和一项 2 期试验（涉及从 18 个月到 70 岁的更广泛年龄组），评估其中一种疫苗。在这里，我们描述了每个疫苗候选物和试验的特征，并将其与世界卫生组织（WHO）对拉沙疫苗的目标产品概况进行了比较。
结论
尽管 LF 疫苗的开发仍处于早期阶段，但目前朝着安全有效的疫苗取得的进展令人鼓舞。
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