Characterization and standardization of Sabin based inactivated polio vaccine: Proposal for a new antigen unit for inactivated polio vaccines

被引:38
作者
Westdijk, Janny [1 ]
Brugmans, Debbie [1 ]
Martin, Javier [2 ]
van't Oever, Aart [1 ]
Bakker, Wilfried A. M. [1 ]
Levels, Lonneke [3 ]
Kersten, Gideon [1 ]
机构
[1] Natl Inst Publ Hlth, Unit Vaccinol, NL-3720 AL Bilthoven, Netherlands
[2] Natl Inst Biol Stand & Controls, Potters Bar, Herts, England
[3] Netherlands Vaccine Inst, NL-3720 AL Bilthoven, Netherlands
关键词
Inactivated polio vaccine; Sabin; Antigenicity; Immunogenicity; IMMUNOGENICITY; STRAINS; ASSAYS; IMMUNIZATION; BIRTH; RATS;
D O I
10.1016/j.vaccine.2011.02.085
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
GMP-batches of Sabin-IPV were characterized for their antigenic and immunogenic properties. Antigenic fingerprints of Sabin-IPV reveal that the D-antigen unit is not a fixed amount of antigen but depends on antibody and assay type. Instead of the D-antigen unit we propose standardization of IPV based on a combination of protein amount for dose and D-antigenicity for quality of the vaccine. Although Sabin-IPV type 2 is less immunogenic than regular wild type IPV type 2, the immunogenicity (virus neutralizing titers) per microgram antigen for Sabin-IPV type 2 is in the same order as for wild type serotypes 1 and 3. The latter observations are in line with data from human trials. This suggests that a higher dose of Sabin-IPV type 2 to compensate for the lower rat immunogenicity may not be necessary. (C) 2011 Elsevier Ltd. All rights reserved.
引用
收藏
页码:3390 / 3397
页数:8
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