This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrowReprints and Permissions
Right arrow Copyright Information
Right arrow Books from ASM Press
Right arrow MicrobeWorld
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Mikolajczyk, M. G.
Right arrow Articles by Scott, D. E.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Mikolajczyk, M. G.
Right arrow Articles by Scott, D. E.

 Previous Article  |  Next Article 

Clinical and Diagnostic Laboratory Immunology, November 2004, p. 1158-1164, Vol. 11, No. 6
1071-412X/04/$08.00+0     DOI: 10.1128/CDLI.11.6.1158-1164.2004

Characterization of Antibodies to Capsular Polysaccharide Antigens of Haemophilus influenzae Type b and Streptococcus pneumoniae in Human Immune Globulin Intravenous Preparations

Malgorzata G. Mikolajczyk,1 Nelydia F. Concepcion,2 Theresa Wang,2 Douglas Frazier,1 Basil Golding,1 Carl E. Frasch,2 and Dorothy E. Scott1*

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,1 Office of Vaccines Research and Review, Division of Bacterial, Parasitic & Allergenic Products, Laboratory of Bacterial Polysaccharides, Bethesda, Maryland2

Received 22 June 2004/ Returned for modification 2 August 2004/ Accepted 9 September 2004

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.

* Corresponding author. Mailing address: FDA/CBER, 1401 Rockville Pike, HFM-345, Rockville, MD 20852. Phone: (301) 827-3015. Fax: (301) 402-2780. E-mail: scottd{at}cber.fda.gov.

Clinical and Diagnostic Laboratory Immunology, November 2004, p. 1158-1164, Vol. 11, No. 6
1071-412X/04/$08.00+0     DOI: 10.1128/CDLI.11.6.1158-1164.2004






Copyright © 2009 by the American Society for Microbiology.   For an alternate route to Journals.ASM.org, visit: http://intl-journals.asm.org | More Info»