Reed Nicholas S, Brewer Carmen C, Akintunde Gideon, Blackie Faustina F, Charles Lovelyn, Fast Patricia, Lambert Paul-Henri, Okogbenin Sylvanus, Paessler Slobodan, Pinschewer Daniel D, Top Karina A, Black Steven B, Dekker Cornelia L
Optimal Aging Institute, New York University Grossman School of Medicine, New York, NY, USA.
Auditory and Vestibular Clinical Research Section (AVCRS), National Institute of Deafness and Other Communication Disorders, NIH, Bethesda, MD, USA.
Vaccine. 2025 Jan 1;43(Pt 1):126525. doi: 10.1016/j.vaccine.2024.126525. Epub 2024 Nov 22.
Lassa virus (LASV) belongs to the Arenavirus family. LASV is endemic in several West Africa countries and causes viral hemorrhagic fevers. The Nigeria CDC has reported that an outbreak in 2024 in 28 states has resulted in 7767 suspected cases of Lassa fever, 971 confirmed cases and 166 confirmed deaths up to 11 August. Since infection with LASV can result in sensorineural hearing loss (SNHL) in up to 30% of patients, there are questions about whether triggering the immune response by immunization with LASV vaccines could potentially cause SNHL, although this has not been shown in clinical trials to date. To address this issue, the Coalition for Epidemic Preparedness Innovations (CEPI) and the Brighton Collaboration (BC) Safety Platform for Emergency vACcines (SPEAC) convened a three-hour webinar on 22 September 2023 to review what is known from both animal studies and human clinical trials and how hearing assessments in future clinical trials can help to assess the risk. This report summarizes the evidence presented and provides considerations for hearing assessment in expanded human trials of LASV vaccine candidates in children and adults.
拉沙病毒（LASV）属于沙粒病毒科。拉沙病毒在西非几个国家流行，可引发病毒性出血热。尼日利亚疾病控制中心报告称，截至8月11日，2024年在28个州爆发的疫情已导致7767例拉沙热疑似病例、971例确诊病例和166例确诊死亡病例。由于感染拉沙病毒的患者中高达30%会出现感音神经性听力损失（SNHL），因此存在关于通过接种拉沙病毒疫苗引发免疫反应是否可能导致SNHL的疑问，尽管迄今为止临床试验中尚未证实这一点。为解决这一问题，流行病防范创新联盟（CEPI）和布莱顿协作组织（BC）紧急疫苗安全平台（SPEAC）于2023年9月22日举办了一场为期三小时的网络研讨会，以回顾动物研究和人体临床试验中的已知情况，以及未来临床试验中的听力评估如何有助于评估风险。本报告总结了所呈现的证据，并为在儿童和成人中开展的拉沙病毒候选疫苗扩大人体试验中的听力评估提供了考量因素。
