Abstract：
OBJECTIVE: Nipah and Hendra are deadly zoonotic diseases with pandemic potential. To date, no human vaccine or monoclonal antibody (mAb) has been licensed to prevent disease caused by these pathogens. The aim of this scoping review was to identify and describe all Phase I, II, and III clinical trials of vaccine candidates or mAbs candidates designed to prevent Nipah and Hendra in humans and to compare the characteristics of the vaccine candidates to characteristics outlined in the Target Product Profile drafted by the World Health Organisation as part of the WHO Research & Development Blueprint for Action to Prevent Epidemics.
METHODS: We searched 23 clinical trial registries, the Cochrane Central Register of Clinical Trials, and grey literature up to June 2023 to identify vaccine and mAb candidates being evaluated in registered clinical trials. Vaccine candidate and trial characteristics were double-extracted for evaluation and the vaccine candidate characteristics were compared with the preferred and critical criteria of the World Health Organisation\'s Target Product Profile for Nipah virus vaccine.
RESULTS: Three vaccine candidates (Hendra Virus Soluble Glycoprotein Vaccine [HeV-sG-V], PHV02, and mRNA-1215) and one mAb (m102.4) had a registered human clinical trial by June 2023. All trials were phase 1, dose-ranging trials taking place in the United States of America or Australia and enrolling healthy adults. Although all vaccine candidates meet the dose regimen and route of administration criteria of the Target Product Profile, other criteria such as measures of efficacy and reactogenicity will need to be evaluated in the future as evidence becomes available.
CONCLUSIONS: Multiple vaccine candidates and one mAb candidate have reached the stage of human clinical trials and are reviewed here. Monitoring progress during evaluation of these candidates and candidates entering clinical trials in the future can help highlight many of the challenges that remain.
METHODS: We searched 23 clinical trial registries, the Cochrane Central Register of Clinical Trials, and grey literature up to June 2023 to identify vaccine and mAb candidates being evaluated in registered clinical trials. Vaccine candidate and trial characteristics were double-extracted for evaluation and the vaccine candidate characteristics were compared with the preferred and critical criteria of the World Health Organisation\'s Target Product Profile for Nipah virus vaccine.
RESULTS: Three vaccine candidates (Hendra Virus Soluble Glycoprotein Vaccine [HeV-sG-V], PHV02, and mRNA-1215) and one mAb (m102.4) had a registered human clinical trial by June 2023. All trials were phase 1, dose-ranging trials taking place in the United States of America or Australia and enrolling healthy adults. Although all vaccine candidates meet the dose regimen and route of administration criteria of the Target Product Profile, other criteria such as measures of efficacy and reactogenicity will need to be evaluated in the future as evidence becomes available.
CONCLUSIONS: Multiple vaccine candidates and one mAb candidate have reached the stage of human clinical trials and are reviewed here. Monitoring progress during evaluation of these candidates and candidates entering clinical trials in the future can help highlight many of the challenges that remain.
摘要：
目的：Nipah和Hendra是致命的人畜共患疾病，具有大流行的潜力。迄今为止,没有人疫苗或单克隆抗体(mAb)被许可用于预防由这些病原体引起的疾病。这次范围审查的目的是确定和描述所有第一阶段，II,以及旨在预防人类Nipah和Hendra的疫苗候选物或单克隆抗体候选物的III临床试验，并将疫苗候选物的特征与世界卫生组织起草的目标产品概况中概述的特征进行比较。
方法：我们搜索了23个临床试验注册中心，Cochrane中央临床试验注册中心,和截至2023年6月的灰色文献，以确定在注册临床试验中正在评估的疫苗和单克隆抗体候选物。将候选疫苗和试验特征双重提取用于评估，并将候选疫苗特征与世界卫生组织尼帕病毒疫苗目标产品概况的首选和关键标准进行比较。
结果：三种候选疫苗（亨德拉病毒可溶性糖蛋白疫苗[HeV-sG-V]，到2023年6月，PHV02和mRNA-1215）和一种mAb（m102.4）进行了注册的人体临床试验。所有试验均为1期，剂量范围试验在美国或澳大利亚进行，并招募健康成年人。尽管所有候选疫苗均符合目标产品概况的剂量方案和给药途径标准，其他标准，如疗效和反应原性的措施，将需要在未来评估，因为证据变得可用。
结论：多种候选疫苗和一种候选单克隆抗体已达到人体临床试验阶段，在此进行综述。在评估这些候选人和未来进入临床试验的候选人期间监测进展可以帮助突出许多仍然存在的挑战。
方法：我们搜索了23个临床试验注册中心，Cochrane中央临床试验注册中心,和截至2023年6月的灰色文献，以确定在注册临床试验中正在评估的疫苗和单克隆抗体候选物。将候选疫苗和试验特征双重提取用于评估，并将候选疫苗特征与世界卫生组织尼帕病毒疫苗目标产品概况的首选和关键标准进行比较。
结果：三种候选疫苗（亨德拉病毒可溶性糖蛋白疫苗[HeV-sG-V]，到2023年6月，PHV02和mRNA-1215）和一种mAb（m102.4）进行了注册的人体临床试验。所有试验均为1期，剂量范围试验在美国或澳大利亚进行，并招募健康成年人。尽管所有候选疫苗均符合目标产品概况的剂量方案和给药途径标准，其他标准，如疗效和反应原性的措施，将需要在未来评估，因为证据变得可用。
结论：多种候选疫苗和一种候选单克隆抗体已达到人体临床试验阶段，在此进行综述。在评估这些候选人和未来进入临床试验的候选人期间监测进展可以帮助突出许多仍然存在的挑战。
