title: Characterization of antibodies to capsular polysaccharide antigens of Haemophilus influenzae type b and Streptococcus pneumoniae in human immune globulin intravenous preparations.
abstract: The most common infections in primary immune deficiency disease (PIDD) patients involve encapsulated bacteria, mainly Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae (pneumococcus). Thus, it is important to know the titers of Hib- and pneumococcus-specific antibodies that are present in immune globulin (Ig) intravenous (IGIV) preparations used to treat PIDD. In this study, seven IGIV preparations were tested by enzyme-linked immunosorbent assay and opsonophagocytic activity for antibody titers to the capsular polysaccharides of Hib and five pneumococcal serotypes. Differences in Hib- and pneumococcus-specific antibody titer were observed among various IGIV preparations, with some products having higher- or lower-than-average titers. Opsonic activity also varied among preparations. As expected, IgG2 was the most active subclass of both binding and opsonic activity except against pneumococcal serotype 6B where IgG3 was the most active. This study determines antibody titers against capsular polysaccharides of Hib and pneumococcus in seven IGIV products that have been shown to be effective in reducing infections in PIDD patients. As donor antibody levels and manufacturing methods continue to change, it may prove useful from a regulatory point of view to reassess IGIV products periodically, to ensure that products maintain antibody levels that are important for the health of IGIV recipients.
authors.affiliation: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Blood Research and Review, Division of Hematology, Laboratory of Plasma Derivatives, Bethesda, MD, USA.
authors.forename: Malgorzata G
authors.initials: MG
authors.lastname: Mikolajczyk
authors.forename: Nelydia F
authors.initials: NF
authors.lastname: Concepcion
authors.forename: Theresa
authors.initials: T
authors.lastname: Wang
authors.forename: Douglas
authors.initials: D
authors.lastname: Frazier
authors.forename: Basil
authors.initials: B
authors.lastname: Golding
authors.forename: Carl E
authors.initials: CE
authors.lastname: Frasch
authors.forename: Dorothy E
authors.initials: DE
authors.lastname: Scott
mesh_terms: D016667:Bacterial Capsules / Q000276:immunology*; D006192:Haemophilus Infections / Q000188:drug therapy; D019741:Haemophilus influenzae type b / Q000276:immunology*; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis / Q000276:immunology; D016756:Immunoglobulins, Intravenous / Q000032:analysis* / Q000276:immunology / Q000627:therapeutic use; D007153:Immunologic Deficiency Syndromes / Q000150:complications / Q000188:drug therapy; D011008:Pneumococcal Infections / Q000188:drug therapy; D011786:Quality Control; D013296:Streptococcus pneumoniae / Q000276:immunology*
chemical_list: D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous