Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified.

IF 3.1 Q2 PHARMACOLOGY & PHARMACY Clinical Pharmacology : Advances and Applications Pub Date : 2018-06-26 eCollection Date: 2018-01-01 DOI:10.2147/CPAA.S166454
Kim Hanna, Maria Cristina Cruz, Elsa Mondou, Edward Corsi, Peter Vandeberg
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引用次数: 6

Abstract

Background: Rabies immune globulin (RIG) and vaccination series are necessary for postexposure prophylaxis. A new formulation of RIG (human) purified by caprylate/chromatography (RIG-C) was evaluated.

Trial registration: ClinicalTrials.gov identifier: NCT02139657.

Materials and methods: This open-label, single-arm study in healthy subjects evaluated neutralizing rabies antibody concentrations produced from a single 20 IU/kg intramuscular (IM) dose of RIG-C as measured by rapid fluorescent focus inhibition test (50% neutralization endpoint) 1-hour postdose and on days 1, 2, 4, 6, 8, 10, 14, 18, and 21.

Results: Twelve subjects were enrolled into the study. No discontinuations, serious adverse events (AEs), or treatment-emergent clinically significant changes in laboratory parameters were observed. All AEs resolved and were mild except 1 moderate AE of oropharyngeal pain. Injection site pain (4 subjects) was most commonly reported. RIG-C produced a rapid increase in neutralizing rabies antibody: mean value 0.113 IU/mL at 24 hours after IM injection, peak on day 4 (0.132 IU/mL), persisting through day 21 (0.116 IU/mL). The mean reciprocal titer was 11.5 by day 2; the peak value of 12.1 was achieved on day 4; and a mean value ≥10.6 was maintained through day 21.

Conclusion: RIG-C was well tolerated and provided neutralizing rabies antibodies, which combined with vaccine series after rabies exposure, should result in effective prophylaxis per World Health Organization/Centers for Disease Control and Prevention guidelines.

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给予单剂量辛酸免疫球蛋白/层析纯化的健康受试者狂犬病抗体的安全性和中和性。
背景:狂犬病免疫球蛋白(RIG)和一系列疫苗接种是暴露后预防的必要条件。采用辛酸酯/层析(RIG- c)纯化了一种新的RIG(人)制剂。试验注册:ClinicalTrials.gov标识符:NCT02139657。材料和方法:这项在健康受试者中进行的开放标签单臂研究评估了单次20 IU/kg肌肉注射(IM)剂量RIG-C产生的中和狂犬病抗体浓度,通过快速荧光聚焦抑制试验(50%中和终点)在给药后1小时和第1、2、4、6、8、10、14、18和21天测量。结果:12名受试者被纳入研究。未观察到停药、严重不良事件(ae)或治疗后出现的实验室参数的临床显著变化。除1例口咽部疼痛的中度AE外,所有AE均缓解,均为轻度AE。注射部位疼痛(4例)最为常见。RIG-C能迅速增加狂犬病中和抗体:注射IM后24小时平均值为0.113 IU/mL,第4天达到峰值(0.132 IU/mL),持续到第21天(0.116 IU/mL)。第2天平均滴度为11.5;第4天达到峰值12.1;平均值≥10.6维持至第21天。结论:RIG-C具有良好的耐受性,并提供了中和狂犬病抗体,根据世界卫生组织/疾病控制和预防中心的指导方针,与狂犬病暴露后的疫苗系列相结合,应能有效预防。
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CiteScore
4.60
自引率
0.00%
发文量
14
审稿时长
16 weeks
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