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Characterization and standardization of Sabin based inactivated polio vaccine: proposal for a new antigen unit for inactivated polio vaccines |
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| Authors: | Westdijk Janny Brugmans Debbie Martin Javier van't Oever Aart Bakker Wilfried A M Levels Lonneke Kersten Gideon |
| Affiliation: | a National Institute for Public Health, Unit Vaccinology, Antonie van Leeuwenhoeklaan 9, 3720 AL Bilthoven, The Netherlands b National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, UK c Netherlands Vaccine Institute Antonie van Leeuwenhoeklaan 11, 3720 AL Bilthoven, The Netherlands |
| Abstract: | 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. |
| Keywords: | Inactivated polio vaccine Sabin Antigenicity Immunogenicity |
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