Background: Immunoglobulin replacement therapy has been used to prevent life threatening infections for the patients with primary and secondary immunodeficiency. This study is performed to evaluate the quantity and quality of antibodies specific to Haemophilus influenzae type b (Hib), 13 serotypes of Streptococcus pneumoniae and 4 serogroups of Neisseria meningitides in various immunoglobulin products from several countries. It can be helpful to assess whether current dose of immunoglobulin is appropriate.
Methods: Nineteen lots of IVIG from 5 manufacturers, 5 lots of IMIG from 4 manufacturers and 1 of subcutaneous IG were evaluated. The concentrations of specific IgG for Hib and 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were studied by ELISA. The functional activities of antibody were analyzed by serum bactericidal assay (SBA) for Hib and meningococcal antibody and multiplexed opsonophagocytic killing assay (MOPA) for pneumococcus.
Results: The quantity and quality of specific antibody in the various immunoglobulin products are shown in Fig 1. When we estimated trough level of IVIG from these data, we can confirm that usual IVIG dose (400 mg/kg) is appropriate for the patients with immunodeficiency to prevent severe infections caused by Hib, most serotypes of pneumococci and meningococci.
Conclusion: Most of immunoglobulin products have sufficient antibodies specific to Hib, pneumococci and meningococci quantitatively and quantitatively. The evaluation of immunoglobulin products may be needed continuously.
Figure 1. Anti-PRP IgG level (a) and serum bactericidal index (b) to Hib, specific IgG levels (c) and opsonophagocitic titer (d) to 13 pneumococcal serotypes, and serum bactericidal index to 4 meningococcal serogroups (e) in immunoglobulin products from various manufacturers.
K. H. Kim, Ministry of Food and Drug Safety: Grant Investigator , Grant recipient