VIRAL INACTIVATION, REMOVAL, AND NEUTRALIZATION IN PLASMA DERIVATIVES

由于我们最近对免疫球蛋白（IG）的安全性研究， 来自在黑猩猩中进行的c100 - 3反应性血浆池（参见Z01 BQ 04006 - 99），我们获得了另外两只黑猩猩来评估 中和抗体在这样的IG制备物中的存在 抗HCV抗体 两种静脉注射免疫球蛋白制剂， 使用;实验含有高水平的HCV抗体 包膜蛋白E1和E2，而对照组几乎没有或没有这样的 抗体的 实验性HCIGIV是一种未经许可的产品， 北美生物制品公司North American Biologicals，Inc.（NABI）的血浆池， 来自198个抗HCV阳性供体的血浆，因此与我们的 之前的实验性HCIG 对照IGIV是商业IGIV 产品Venezuulin-S，由大量血浆捐献制备 所有这些都通过多抗原EIA筛选。 两种制剂都有 在其制造过程中进行了溶剂-洗涤剂处理， 当通过我们的RT-PCR检测时，可检测到HCV RNA。 实验 黑猩猩被注入由1毫升标准的 体外预孵育含64 CID50的HCV接种物（H株）， 50 ml的5%HCIGIV在4 ℃下24 h，而对照黑猩猩 将接受与50 ml 5% 在相同的条件下， 在输注8个月后， 这两种黑猩猩都没有出现丙氨酸氨基转移酶（ALT）升高， （等于或高于基础值的2.5倍） 血清标本 这项研究仍在进行中。 如果HCIGIV含有 HCV的中和抗体，受体黑猩猩不应该 感染HCV，而对照组应感染HCV。

Because of our recent safety study of an Immune Globulin (IG) prepared from a c100-3 reactive plasma pool performed in a chimpanzee (see Z01 BQ 04006-99), we obtained two additional chimpanzees for assessing the presence of neutralizing antibodies in such an IG preparation enriched in antibodies to HCV. Two intravenous immunoglobulin preparations were used; the experimental contained high levels of antibodies to HCV envelope proteins, E1 and E2, while the control had little or no such antibodies. The experimental HCIGIV is an unlicensed product prepared by North American Biologicals, Inc. (NABI) from a plasma pool consisting of plasma from 198 anti-HCV positive donors and hence similar to our previous experimental HCIG. The control IGIV was a commercial IGIV product, Venoglobulin-S, which was prepared from large plasma donations all of which screened by the multiantigen EIA. Both preparations had been solvent-detergent treated in their manufacture and did not have detectable HCV RNA when assayed by our RT-PCR assay. The experimental chimpanzee was infused with a mixture consisting of 1 ml of a standard HCV inoculum (H-strain) containing 64 CID50 preincubated in vitro with 50 ml of 5% HCIGIV at 4 degrees C for 24 h while the control chimpanzee will receive the same CID50 inoculum preincubated with 50 ml of 5% Vinoglobulin-S under the same conditions. After 8 months of infusion, neither chimpanzee has yet had elevated alanine aminotransferase (ALT) (equal to or higher than 2.5 times of the basal value) in their weekly serum specimens. The study is still in progress. If HCIGIV contains neutralizing antibodies to HCV, the recipient chimpanzee should not contract HCV infection while the control should.