Differences in Antigenic Structure of Inactivated Polio Vaccines Made From Sabin Live-Attenuated and Wild-Type Poliovirus Strains: Impact on Vaccine Potency Assays

Crawt, Laura; Atkinson, Eleanor; Tedcastle, Alison; Pegg, Elaine; Minor, Philip D.; Cooper, Gillian; Rigsby, Peter; Martı́n, Javier

doi:10.1093/infdis/jiz076

Cited by 16 publications

(13 citation statements)

References 12 publications

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“…sIPV-induced antibodies have been shown to be cross-reactive against almost all poliovirus strains tested – Sabin, Salk, cVDPV and wild-type – the exception being an isolate excreted from an immunodeficient individual (iVDPV) [34] . In a collaborative study to establish standards for sIPV there were some small variations in antigen-specificity between Sabin and other polioviruses used by different manufacturers, including those used by Takeda [35] . However, these variations were too small to account for the low responses we observed.…”

Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity of experimental stand-alone trivalent, inactivated Sabin-strain polio vaccine formulations in healthy infants: A randomized, observer-blind, controlled phase 1/2 trial

Cramer

Jimeno

Han

et al. 2020

Vaccine

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Highlights A novel IPV vaccine was developed from attenuated Sabin poliovirus strains. The vaccine was generally well tolerated in adults, toddlers and infants. The vaccine was immunogenic as a booster in previously polio-vaccinated toddlers. The vaccine was insufficiently immunogenic from 6 weeks of age in the EPI schedule. There was evidence of interference of the immune response by maternal antibodies.

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Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity of experimental stand-alone trivalent, inactivated Sabin-strain polio vaccine formulations in healthy infants: A randomized, observer-blind, controlled phase 1/2 trial

Cramer

Jimeno

Han

et al. 2020

Vaccine

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“…This could be partially explained by the yet to be cleared correlation between in vitro and in vivo potency assays in case of sIPV products. Such correlation has been long established and proved for conventional Salk IPV vaccines [38]. Also, previous studies showed that in some cases the loss of the D-antigen did not impact significantly on the in vivo potency of sIPV vaccine [40].…”

Section: Discussionmentioning

confidence: 70%

“…Previous studies showed antigenic differences between traditional Salk-IPV and IPV made from Sabin strains [37]. These studies recommended the formulation of a new international reference standard to measure the D-antigen content and assess the potency of the s-IPV products [38]. For this reason; four identical trivalent vaccine preparations were formulated; the only difference between them is the inactivating agent and these preparations were tested for their safety and immunogenicity.…”

Section: Discussionmentioning

confidence: 99%

In-Vitro Inactivation of Sabin-Polioviruses for Development of Safe and Effective Polio Vaccine

et al. 2020

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After years of global collaboration; we are steps away from a polio-free world. However, the currently conventional inactivated polio vaccine (cIPV) is suboptimal for the post eradication era. cIPV production cost and biosafety hazards hinder its availability and coverage of the global demands. Production of IPV from the attenuated Sabin strains (sIPV) was an ideal solution and scientists work extensively to perfect a safe, effective and affordable sIPV. This study investigated the ability of hydrogen peroxide (H2O2), ascorbic acid (AA) and epigallocatechin-3-gallate (EGCG) as alternatives for Formaldehyde (HCHO) to inactivate Sabin-polioviruses strains for sIPV production. Sabin-polioviruses vaccine strains were individually treated with AA, EGCG or H2O2 and were compared to HCHO. This was investigated by determination of the inactivation kinetics on HEP2C cells, testing of D-antigen preservation by ELISA and the immune response in Wistar rats of the four vaccine preparations. H2O2, AA and EGCG were able to inactivate polioviruses within 24 h while HCHO required 96 h. Significant high D-antigen levels were observed using AA, EGCG and H2O2 compared to HCHO. Rat sera tested for neutralizing antibodies showed comparable results. These findings support the idea of using these inactivating agents as safe and time- saving alternatives for HCHO to produce sIPV.

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“…13 After being stored at −20°C overnight, the D-antigen contents of 17/234 candidate samples were decreased by 3.5% to 7.6% and were decreased by 29.9% to 60.2% after being stored at −20°C for 2 weeks. 17,18 These results indicate that the stability of the sIPV at freezing is similar to that of the wIPV, featuring the same sensitivity of inactivated polio characteristics with a significant decrease in D-antigens. 12 As observed with the potency of the wIPV, which remained qualified after exposure at −20°C for ≤7 days, 12 sIPVs exposed to freezing conditions at −20°C for 1 day or 1 week exhibited no significant reduction in immunogenicity in the in vivo analysis in the present study.…”

Section: Discussionmentioning

confidence: 81%

Potency of the Sabin inactivated poliovirus vaccine (sIPV) after exposure to freezing temperatures in cold chains

Cai

Ling

Shen

et al. 2020

Human Vaccines & Immunotherapeutics

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With more demand for Sabin inactivated poliovirus vaccines (sIPVs) to support the global polio eradication effort worldwide, data regarding the potency characteristics of sIPV after exposure to freezing temperatures are urgently required. In the present study, the sIPVs were stored at −20°C for 24 h, 1 week, and 2 weeks in the freezer or in a vaccine carrier for 1 or 3 freeze-thaw cycle to evaluate the effect mediated by freezing temperatures that may be encountered during routine storage and transfer. The in vitro potency was then determined by a D-antigen enzyme-linked immunosorbent assay, and the in vivo potency was evaluated in Wistar rats. In the in vitro study for freezer storage groups, the D-antigen contents for all three types decreased and were lower than the release specifications after storing at −20°C for 2 weeks. After storing at −20°C for 1 week, the D-antigen contents for types I and III in combined group of a total of 45 vials, and for type II in the specific lot groups containing 15 vials decreased, but were within the release specifications. Moreover, no significant change in in vivo potency was observed. For vaccine carrier transfer groups, the D-antigen contents did not decrease after 1 freeze-thaw cycle; in contrast, it decreased, but no significant in vivo potency loss was observed after 3 freeze-thaw cycles. These results suggest that it may be possible to retain sufficient sIPV potency after short periods of freezing or freeze-thawing during transport.

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Differences in Antigenic Structure of Inactivated Polio Vaccines Made From Sabin Live-Attenuated and Wild-Type Poliovirus Strains: Impact on Vaccine Potency Assays

Cited by 16 publications

References 12 publications

Safety and immunogenicity of experimental stand-alone trivalent, inactivated Sabin-strain polio vaccine formulations in healthy infants: A randomized, observer-blind, controlled phase 1/2 trial

Safety and immunogenicity of experimental stand-alone trivalent, inactivated Sabin-strain polio vaccine formulations in healthy infants: A randomized, observer-blind, controlled phase 1/2 trial

In-Vitro Inactivation of Sabin-Polioviruses for Development of Safe and Effective Polio Vaccine

Potency of the Sabin inactivated poliovirus vaccine (sIPV) after exposure to freezing temperatures in cold chains

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