title: Analyzing titers of antibodies against bacterial and viral antigens, and bacterial toxoids in the intravenous immunoglobulins utilized in Taiwan.
abstract: Intravenous immunoglobulin (IVIG) manufactured from human plasma contains IgG as the primary ingredient, and is used for indications such as immunodeficiency syndrome. Available IVIGs in Taiwan are either manufactured from Taiwanese or North American plasma. The effectiveness of the national immunization program of Taiwan can be evaluated by analyzing and comparing IVIG antibody titers that are induced through the corresponding vaccines (tetanus, diphtheria, and pertussis, measles, rubella, hepatitis A, hepatitis B and varicella). Both enzyme-linked immunosorbent assay (ELISA) and the in vitro neutralization test demonstrated that all IVIGs provide adequate clinical protection against diphtheria and tetanus toxins. ELISA results further revealed that plasma of Taiwanese subjects contains higher levels of pertussis toxin and filamentous hemagglutinin antibodies, when compared to foreign IVIGs. This may be related to the later adoption of acellular pertussis vaccine in Taiwan. Antibodies titers against measles, rubella, hepatitis A, and varicella-zoster virus were otherwise low. Low titers of hepatitis B surface antigen antibodies are present in Taiwanese plasma IVIG, indicating immune memory decline or loss. In conclusion, our results show that Taiwanese IVIG contains varying titers of vaccine-induced antibodies, and serves as a guide for future amendments to Taiwan's immunization program.
authors.affiliation: Section of Biologics & Advanced Therapeutic Product Analysis, Division of Research and Analysis, Food and Drug Administration, Department of Health, Executive Yuan, Taiwan, ROC.
authors.forename: Chi-Yu
authors.initials: CY
authors.lastname: Wu
authors.forename: Hsiu-Chi
authors.initials: HC
authors.lastname: Wang
authors.forename: Kun-Teng
authors.initials: KT
authors.lastname: Wang
authors.forename: Daniel
authors.initials: D
authors.lastname: Yang-Chih Shih
authors.forename: Chi-Fang
authors.initials: CF
authors.lastname: Lo
authors.forename: Der-Yuan
authors.initials: DY
authors.lastname: Wang
mesh_terms: D000906:Antibodies / Q000097:blood / Q000276:immunology*; D000942:Antigens, Bacterial / Q000276:immunology*; D000956:Antigens, Viral / Q000276:immunology*; D001428:Bacterial Vaccines / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D017589:Immunization Programs / Q000379:methods / Q000592:standards; D016756:Immunoglobulins, Intravenous / Q000276:immunology*; D013624:Taiwan; D014121:Toxoids / Q000276:immunology*; D014765:Viral Vaccines / Q000276:immunology
chemical_list: D000906:Antibodies; D000942:Antigens, Bacterial; D000956:Antigens, Viral; D001428:Bacterial Vaccines; D016756:Immunoglobulins, Intravenous; D014121:Toxoids; D014765:Viral Vaccines