目的:日内瓦大学医院获得临时授权,在部署任务之前,向外籍人道主义前线工作人员(FLW)接种重组水疱性口炎病毒rVSV-ZEBOV(Ervebo®)活疫苗。
目的:我们的目的是在部署前评估FLW疫苗接种的可行性并报告不良事件(AE)。
方法:FLW在日内瓦大学医院旅行医学诊所(第0天)的部署前体检期间接受了一次rVSV-ZEBOV(>7.2E7斑块形成单元)注射。在第3天和第21天,将有关潜在AE的安全性问卷通过电子邮件发送给FLW。早期和延迟的AE是在接种疫苗后3或21天内开始的那些,分别。
结果:在2019年8月1日至2020年6月30日期间,124名FLW接受了rVSV-ZEBOV疫苗。86名志愿者(86/124;69%)接受了伴随疫苗。在第3天和第21天,对随访问卷的应答率分别为88%和55%。大多数受访者(105/109;96.3%),至少经历过一次AE,平均每人三次(±SD1.75)AE。最常见的AE是注射部位疼痛,其次是发烧(53/109;48.6%),疲劳(51/109;46.7%)和肌痛(49/109;44.9%)。大多数早期不良事件(360/377;95.4%)在3天内解决,反映疫苗反应原性。6/69(7.2%)受试者报告了延迟的AE,至症状发作的中位时间为11天(范围:5~14天);其中一半为关节相关AE(3/6).观察到4例严重不良事件(SAE):2例高热,一个皮疹和一个关节炎病例。观察到两个可疑的意外严重不良反应:一例持续反复发作的短暂性头晕和疲劳被认为与疫苗有关;以及一例被认为与疫苗无关的老花眼。
结论:rVSV-ZEBOV的不良事件是常见的,但一般是一过性的,耐受性良好,在FLW中进行部署前rVSV-ZEBOV疫苗接种是可行的,并且可以包括在任务前检查中。
OBJECTIVE: Geneva University Hospitals were granted a temporary authorization to administer the recombinant live vesicular stomatitis virus rVSV-ZEBOV (Ervebo®) vaccine to expatriate humanitarian frontline workers (FLWs) prior to mission deployment.
OBJECTIVE: Our aims were to assess the feasibility of FLW vaccination before deployment and to report adverse events (AEs).
METHODS: FLWs received a single injection of rVSV-ZEBOV (>7.2E7 plaque forming unit) during their pre-deployment medical check-up at the Travel Medicine Clinic of the Geneva University Hospitals (Day 0). A safety questionnaire regarding potential AEs was emailed to FLWs on Days 3 and 21. Early and delayed AEs were those starting within 3 or 21 days of vaccination, respectively.
RESULTS: Between 1 August 2019 and 30 June 2020, 124 FLWs received the rVSV-ZEBOV vaccine. Eighty-six volunteers (86/124; 69%) received a concomitant vaccine. The response rate to the follow-up questionnaire was 88 and 55% at Days 3 and 21, respectively. Most respondents (105/109; 96.3%), experienced at least one AE, with a mean of three (±SD 1.75) AEs per person. The most common AE was injection site pain, followed by fever (53/109; 48.6%), fatigue (51/109; 46.7%) and myalgia (49/109; 44.9%). Most early AEs (360/377; 95.4%) resolved within 3 days, reflecting vaccine reactogenicity. Delayed AEs were reported by 6/69 (7.2%) subjects, the median time to symptom onset was 11 days (range: 5-14); half of them were joint-related AEs (3/6). Four serious adverse events (SAE) were observed: two cases of high grade fever, one rash and one case of arthritis. Two suspected unexpected serious adverse reactions were observed: one case of continuing recurrent transient dizziness and fatigue considered related to the vaccine; and one case of presbyopia that was deemed unrelated.
CONCLUSIONS: AEs to rVSV-ZEBOV were common but in general transient and were well tolerated, pre-deployment rVSV-ZEBOV vaccination in FLW is feasible and can be included with pre-mission check-up.