关键词: LASV clinical trial priority pathogens vaccine candidate vaccine development viral haemorrhagic fever

Mesh : Humans Lassa Fever / prevention & control drug therapy Lassa virus Viral Vaccines / therapeutic use

来  源:   DOI:10.1111/tmi.13876   PDF(Pubmed)

Abstract:
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.
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.
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.
Though LF vaccine development is still in early stages, current progress towards a safe and effective vaccine is encouraging.
摘要:
目的:拉沙热(LF)是由具有大流行潜力的病毒病原体引起的。LF疫苗有可能预防有感染风险的个体的重大疾病,但是到目前为止,还没有此类疫苗获得许可或授权使用。我们进行了范围审查,以确定和比较已注册的1、2或3期LF疫苗候选临床试验,并评估了LF疫苗的当前发展轨迹。
方法:我们系统地搜索了24个试验注册中心,PubMed,相关会议摘要和额外的灰色文献来源,截至2022年10月27日。在提取了每个候选疫苗和每个合格试验的关键细节之后,我们定性地综合了证据.
结果:我们发现了四种LF疫苗候选物(INO-4500,MV-LASV,rVSV÷G-LASV-GPC,和EBS-LASV)已进入临床评估阶段。迄今为止,已经注册了五项1期试验(全部针对健康成年人)和一项2期试验(涉及18个月至70岁的更广泛的年龄组)评估其中一种疫苗。这里,我们描述了每种候选疫苗和试验的特征,并将它们与WHO的拉萨疫苗目标产品概况进行了比较。
结论:尽管LF疫苗开发仍处于早期阶段,目前在安全有效疫苗方面取得的进展令人鼓舞。
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