Comparison of two different preparations of HIV immune globulin for efficiency of neutralization of HIV type 1 primary isolates.

The objective of this study was to compare the virus-neutralizing ability of two different preparations of HIV immune globulin (HIVIG) isolated from human plasma units that were selected according to two different criteria. The first preparation, designated NYBC-HIVIG, was isolated from plasmas with high neutralizing antibody titers against HIV-1. The second preparation, designated NABI-HIVIG, was isolated from plasma with high titers of antibody to the HIV-1 p24 antigen. A panel of primary HIV-1 isolates was phenotypically characterized by their ability to induce syncytia in CEM-SS cells. Neutralization of this panel of primary isolates by the two HIVIG preparations was assessed in HeLa-MAGI-CCR5 cells, utilizing a luminescence-based assay. In addition, the reactivities of these two preparations with a panel of HIV-1 gp120 proteins, V3 loop peptides, and HIV-1 p24 antigen were determined. Both HIVIG preparations were shown to neutralize all virus isolates tested. However, doses of NABI-HIVIG required for 50% virus neutralization were 2.2- to 4.4- fold (mean, 3.2-fold) higher than the required doses of NYBC-HIVIG. Comparative antigen-binding assays showed that, although NABI-HIVIG possessed higher titers of antibody to HIV-1 p24, NYBC-HIVIG generally contained higher titers of antibody to HIV-1 gp120 and V3 peptides. These experiments show that the criteria used for selection of source plasmas for isolation of HIVIG can influence the effective concentration of virus-neutralizing antibody present in the final immunoglobulin preparation, and may determine the doses required for clinical efficacy.