Abstract
Molecular size distribution of meningococcal polysaccharide vaccine is a readily identifiable parameter that directly correlates with the immunogenicity. In this paper, we report a size exclusion chromatography method to determine the molecular size distribution and distribution coefficient value of meningococcal polysaccharide serogroups A, C, W, and Y in meningococcal polysaccharide (ACWY) vaccines. The analyses were performed on a XK16/70 column packed with sepharose CL-4B with six different batches of Ingovax® ACWY, a meningococcal polysaccharide vaccine produced by Incepta Vaccine Ltd., Bangladesh. A quantitative rocket immunoelectrophoresis assay was employed to determine the polysaccharide contents of each serogroup. The calculated distribution coefficient values of serogroups A, C, W, and Y were found to be 0.26 ± 0.16, 0.21 ± 0.11, 0.21 ± 0.11, and 0.14 ± 0.12, respectively, and met the requirements of British Pharmacopeia. The method was proved to be robust for determining the distribution coefficient values which is an obligatory requirement for vaccine lot release.
Highlights
Neisseria meningitidis is the prime cause of bacterial meningitis and fatal sepsis in human [1, 2]
Serogroups A, C, W, and Y are the main causes of epidemic meningitis and protective vaccines are available against these serogroups [6]
In Bangladesh, bacterial meningitis from meningococcal infection causes a significant morbidity and mortality in adults and children [16, 17]. It was reported in a study of bacterial meningitis that 136 of 189 diagnosed patients had Neisseria meningitidis group A or C infection in Bangladesh
Summary
Neisseria meningitidis is the prime cause of bacterial meningitis and fatal sepsis in human [1, 2]. The idea of molecular size based separation by chromatography, known as size exclusion chromatography (SEC), was first introduced by Synge [24] It is a widely used technique for determining the molecular size distribution (MSD) of polymeric materials (e.g., proteins, nucleic acids, and polysaccharides) [25]. It is difficult to estimate serospecific polysaccharide content by above-mentioned assays from a mixture of ACWY polysaccharides in tetravalent meningococcal PS vaccine. We described a SEC method for determination of MSD of tetravalent meningococcal polysaccharide vaccine of ACWY. This experiment mainly focused on calculation and comparative analysis of distribution coefficient (KD) value of each serogroup of six different batches of meningococcal PS vaccines
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