Background Convalescent plasma has been used to treat many viral diseases including Ebola. The manufacture of a purified anti-Ebola virus (EBOV) intravenous immunoglobulin (IVIG) from pooled convalescent plasma is described in this paper. Methods An enzyme-linked immunosorbent assay (ELISA) targeting an EBOV surface glycoprotein antigen was used to determine the immunoglobulin titer of pooled plasma and purified anti-EBOV IVIG. Anti-EBOV IVIG was also tested in neutralization assays using a vesicular stomatitis virus pseudovirion expressing EBOV glycoprotein on its surface and with live EBOV. Finally, the efficacy of the anti-EBOV IVIG was assessed in a mouse model of EBOV infection. Results In the ELISA, the anti-EBOV IVIG was shown to have a 7-fold increase in immunoglobulin G (IgG) titer over pooled convalescent plasma. In both the pseudovirion and live virus assays, the anti-EBOV IVIG showed approximately 5- to 6-fold increased potency over pooled plasma. Anti-EBOV IVIG also significantly improved survivability in mice infected with the virus when administered concurrently or 2 days after infection. Conclusions These data support this purified anti-EBOV IVIG merits additional investigation and clinical trials for treatment and postexposure prophylaxis of Ebola virus disease. The experience gained can be applied to manufacture hyperimmune globulins against other emerging viruses.

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来自恢复期血浆的抗埃博拉病毒超免疫球蛋白的表征

背景恢复期血浆已被用于治疗许多病毒性疾病，包括埃博拉病毒。本文描述了从合并的恢复期血浆中制备纯化的抗埃博拉病毒 (EBOV) 静脉注射免疫球蛋白 (IVIG)。方法 采用针对 EBOV 表面糖蛋白抗原的酶联免疫吸附试验 (ELISA) 测定混合血浆和纯化的抗 EBOV IVIG 的免疫球蛋白滴度。还使用在其表面表达 EBOV 糖蛋白的水泡性口炎病毒假病毒粒子和活 EBOV 在中和试验中测试了抗 EBOV IVIG。最后，在 EBOV 感染的小鼠模型中评估了抗 EBOV IVIG 的功效。结果 在 ELISA 中，抗 EBOV IVIG 的免疫球蛋白 G (IgG) 滴度比合并的恢复期血浆高 7 倍。在假病毒颗粒和活病毒检测中，抗 EBOV IVIG 的效力比混合血浆高约 5 至 6 倍。当同时或感染后 2 天给药时，抗 EBOV IVIG 还显着提高了感染病毒的小鼠的存活率。结论 这些数据支持这种纯化的抗 EBOV IVIG 值得进一步研究和临床试验，用于治疗和暴露后预防埃博拉病毒病。获得的经验可用于制造针对其他新兴病毒的超免疫球蛋白。结论 这些数据支持这种纯化的抗 EBOV IVIG 值得进一步研究和临床试验，用于治疗和暴露后预防埃博拉病毒病。获得的经验可用于制造针对其他新兴病毒的超免疫球蛋白。结论 这些数据支持这种纯化的抗 EBOV IVIG 值得进一步研究和临床试验，用于治疗和暴露后预防埃博拉病毒病。获得的经验可用于制造针对其他新兴病毒的超免疫球蛋白。