We are conducting a prospective cohort study in Benin, Guinea, Liberia, Nigeria (three sites), and Sierra Leone from 2020 to 2023, with 24 months of follow-up. Each site will assess the incidence of LASV infection, LF disease, or both. When both incidences are assessed the LASV cohort (nmin = 1000 per site) will be drawn from the LF cohort (nmin = 5000 per site). During recruitment participants will complete questionnaires on household composition, socioeconomic status, demographic characteristics, and LF history, and blood samples will be collected to determine IgG LASV serostatus. LF disease cohort participants will be contacted biweekly to identify acute febrile cases, from whom blood samples will be drawn to test for active LASV infection using RT-PCR. Symptom and treatment data will be abstracted from medical records of LF cases. LF survivors will be followed up after four months to assess sequelae, specifically sensorineural hearing loss. LASV infection cohort participants will be asked for a blood sample every six months to assess LASV serostatus (IgG and IgM).
Data on LASV infection and LF disease incidence in West Africa from this research programme will determine the feasibility of future Phase IIb or III clinical trials for LF vaccine candidates.
方法:我们正在贝宁进行一项前瞻性队列研究,几内亚,利比里亚,尼日利亚(三个地点),和塞拉利昂,从2020年到2023年,有24个月的随访。每个站点将评估LASV感染的发生率,LF病,或者两者兼而有之。当评估两种发病率时,将从LF群组(nmin=5000/位点)中抽取LASV群组(nmin=1000/位点)。在招募期间,参与者将填写有关家庭组成的问卷,社会经济地位,人口特征,和LF历史,和血液样本将被收集以确定IgGLASV血清状态。LF疾病队列参与者将每两周联系一次,以确定急性发热病例。将从中抽取血液样本,使用RT-PCR检测活跃的LASV感染。症状和治疗数据将从LF病例的医疗记录中提取。LF幸存者将在四个月后进行随访,以评估后遗症,特别是感音神经性听力损失。LASV感染队列参与者将被要求每六个月提供一次血液样本,以评估LASV血清状态(IgG和IgM)。
结论:来自本研究计划的西非LASV感染和LF疾病发病率数据将确定LF候选疫苗未来IIb期或III期临床试验的可行性。