Department of Pediatrics, Division of Pediatric Emergency Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Department of Medical Affairs, Kamada Ltd., Beit Kama, Israel.
Hum Vaccin Immunother. 2021 Jul 3;17(7):2090-2096. doi: 10.1080/21645515.2020.1854000. Epub 2021 Feb 9.
Rabies is a deadly viral zoonosis with global disease burden. Following exposure to a rabid animal, post-exposure prophylaxis (PEP) is the standard of care for unvaccinated persons. Despite the large proportion of pediatric cases, limited safety and efficacy data exist for use in pediatric patients. We report the safety, efficacy, and immunogenicity of a phase 4, prospective, 2-center, open-label, single-arm clinical trial evaluating human rabies immunoglobulin (HRIG150; KEDRAB 150 IU/mL) as part of PEP in patients (aged <17) with suspected or confirmed rabies exposure, where PEP was indicated. Thirty participants received 20 IU/kg HRIG150 infiltrated into the detectable wound site(s), with any remainder injected intramuscularly, concomitantly with the first of a 4-dose series (days 0, 3, 7, and 14) of rabies vaccine. Rabies virus neutralizing antibody (RVNA) titers and tolerability were assessed on day 14 following administration. Participant safety was monitored for 84 days. No serious adverse events, rabies infections, or deaths were recorded. Twenty-one participants (70.0%) experienced a total of 57 treatment-emergent adverse events (TEAEs) within 14 days following administration. Twelve participants (40.0%) experienced a total of 13 adverse events deemed treatment related. All TEAEs were mild in severity. On day 14, 28 participants (93.3%) had RVNA levels of ≥0.5 IU/mL (mean±standard deviation: 18.89 ± 31.61). These results demonstrate that HRIG150 is well tolerated and effective in pediatric patients as a component of PEP. To the authors' knowledge, this study is the first to establish pediatric safety and efficacy of HRIG in the US.
狂犬病是一种具有全球疾病负担的致命病毒性人畜共患病。接触狂犬病动物后，对未接种疫苗的人进行暴露后预防（PEP）是标准的治疗方法。尽管儿科病例比例较大，但用于儿科患者的安全性和疗效数据有限。我们报告了一项 4 期、前瞻性、2 中心、开放标签、单臂临床试验的安全性、疗效和免疫原性，该试验评估了人狂犬病免疫球蛋白（HRIG150；KEDRAB 150 IU/mL）作为有疑似或确诊狂犬病暴露的患者（年龄<17 岁）PEP 的一部分，PEP 是指征。30 名参与者接受了 20 IU/kg HRIG150 皮内注射到可检测的伤口部位，任何剩余的药物都肌肉内注射，同时给予狂犬病疫苗的 4 剂系列（第 0、3、7 和 14 天）的第一剂。在给药后第 14 天评估狂犬病病毒中和抗体（RVNA）滴度和耐受性。监测参与者的安全性 84 天。未记录到严重不良事件、狂犬病感染或死亡。21 名参与者（70.0%）在给药后 14 天内总共发生了 57 次治疗中出现的不良事件（TEAEs）。12 名参与者（40.0%）总共发生了 13 次被认为与治疗相关的不良事件。所有 TEAEs 的严重程度均为轻度。在第 14 天，28 名参与者（93.3%）的 RVNA 水平≥0.5 IU/mL（平均值±标准差：18.89±31.61）。这些结果表明，HRIG150 作为 PEP 的一部分，在儿科患者中具有良好的耐受性和有效性。据作者所知，这是第一项在美国确立 HRIG 在儿科人群中安全性和疗效的研究。
