Development of an ELISA-Based Potency Assay for Inactivated Influenza Vaccines Using Cross-Reactive Nanobodies
Inactivated vaccines are the main influenza vaccines used today; these are usually presented as split (detergent-disrupted) or subunit vaccines, while whole-virus-inactivated influenza vaccines are rare. The single radial immune diffusion (SRD) assay has been used as the gold standard potency assay...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-09-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/10/9/1473 |
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| author | Chung Y. Cheung Sitara Dubey Martina Hadrovic Christina R. Ball Walter Ramage Jacqueline U. McDonald Ruth Harvey Simon E. Hufton Othmar G. Engelhardt |
| author_facet | Chung Y. Cheung Sitara Dubey Martina Hadrovic Christina R. Ball Walter Ramage Jacqueline U. McDonald Ruth Harvey Simon E. Hufton Othmar G. Engelhardt |
| author_sort | Chung Y. Cheung |
| collection | DOAJ |
| description | Inactivated vaccines are the main influenza vaccines used today; these are usually presented as split (detergent-disrupted) or subunit vaccines, while whole-virus-inactivated influenza vaccines are rare. The single radial immune diffusion (SRD) assay has been used as the gold standard potency assay for inactivated influenza vaccines for decades; however, more recently, various alternative potency assays have been proposed. A new potency test should be able to measure the amount of functional antigen in the vaccine, which in the case of influenza vaccines is the haemagglutinin (HA) protein. Potency tests should also be able to detect the loss of potency caused by changes to the structural and functional integrity of HA. To detect such changes, most alternative potency tests proposed to date use antibodies that react with native HA. Due to the frequent changes in influenza vaccine composition, antibodies may need to be updated in line with changes in vaccine viruses. We have developed two ELISA-based potency assays for group 1 influenza A viruses using cross-reactive nanobodies. The nanobodies detect influenza viruses of subtype H1N1 spanning more than three decades, as well as H5N1 viruses, in ELISA. We found that the new ELISA potency assays are sensitive to the nature of the reference antigen (standard) used to quantify vaccine antigens; using standards matched in their presentation to the vaccine type improved correspondence between the ELISA and SRD assays. |
| first_indexed | 2024-03-09T22:17:03Z |
| format | Article |
| id | doaj.art-30c7f237bf71402782455202486336c6 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-09T22:17:03Z |
| publishDate | 2022-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-30c7f237bf71402782455202486336c62023-11-23T19:21:41ZengMDPI AGVaccines2076-393X2022-09-01109147310.3390/vaccines10091473Development of an ELISA-Based Potency Assay for Inactivated Influenza Vaccines Using Cross-Reactive NanobodiesChung Y. Cheung0Sitara Dubey1Martina Hadrovic2Christina R. Ball3Walter Ramage4Jacqueline U. McDonald5Ruth Harvey6Simon E. Hufton7Othmar G. Engelhardt8Vaccines Division, Scientific Research & Innovation, Medicines and Healthcare Products Regulatory Agency, South Mimms, Potters Bar EN6 3QG, UKVaccines Division, Scientific Research & Innovation, Medicines and Healthcare Products Regulatory Agency, South Mimms, Potters Bar EN6 3QG, UKVaccines Division, Scientific Research & Innovation, Medicines and Healthcare Products Regulatory Agency, South Mimms, Potters Bar EN6 3QG, UKBiotherapeutics Division, Scientific Research & Innovation, Medicines and Healthcare Products Regulatory Agency, South Mimms, Potters Bar EN6 3QG, UKBiotherapeutics Division, Scientific Research & Innovation, Medicines and Healthcare Products Regulatory Agency, South Mimms, Potters Bar EN6 3QG, UKVaccines Division, Scientific Research & Innovation, Medicines and Healthcare Products Regulatory Agency, South Mimms, Potters Bar EN6 3QG, UKVaccines Division, Scientific Research & Innovation, Medicines and Healthcare Products Regulatory Agency, South Mimms, Potters Bar EN6 3QG, UKBiotherapeutics Division, Scientific Research & Innovation, Medicines and Healthcare Products Regulatory Agency, South Mimms, Potters Bar EN6 3QG, UKVaccines Division, Scientific Research & Innovation, Medicines and Healthcare Products Regulatory Agency, South Mimms, Potters Bar EN6 3QG, UKInactivated vaccines are the main influenza vaccines used today; these are usually presented as split (detergent-disrupted) or subunit vaccines, while whole-virus-inactivated influenza vaccines are rare. The single radial immune diffusion (SRD) assay has been used as the gold standard potency assay for inactivated influenza vaccines for decades; however, more recently, various alternative potency assays have been proposed. A new potency test should be able to measure the amount of functional antigen in the vaccine, which in the case of influenza vaccines is the haemagglutinin (HA) protein. Potency tests should also be able to detect the loss of potency caused by changes to the structural and functional integrity of HA. To detect such changes, most alternative potency tests proposed to date use antibodies that react with native HA. Due to the frequent changes in influenza vaccine composition, antibodies may need to be updated in line with changes in vaccine viruses. We have developed two ELISA-based potency assays for group 1 influenza A viruses using cross-reactive nanobodies. The nanobodies detect influenza viruses of subtype H1N1 spanning more than three decades, as well as H5N1 viruses, in ELISA. We found that the new ELISA potency assays are sensitive to the nature of the reference antigen (standard) used to quantify vaccine antigens; using standards matched in their presentation to the vaccine type improved correspondence between the ELISA and SRD assays.https://www.mdpi.com/2076-393X/10/9/1473influenzavaccinepotency testnanobodiesELISAcross-reactive |
| spellingShingle | Chung Y. Cheung Sitara Dubey Martina Hadrovic Christina R. Ball Walter Ramage Jacqueline U. McDonald Ruth Harvey Simon E. Hufton Othmar G. Engelhardt Development of an ELISA-Based Potency Assay for Inactivated Influenza Vaccines Using Cross-Reactive Nanobodies Vaccines influenza vaccine potency test nanobodies ELISA cross-reactive |
| title | Development of an ELISA-Based Potency Assay for Inactivated Influenza Vaccines Using Cross-Reactive Nanobodies |
| title_full | Development of an ELISA-Based Potency Assay for Inactivated Influenza Vaccines Using Cross-Reactive Nanobodies |
| title_fullStr | Development of an ELISA-Based Potency Assay for Inactivated Influenza Vaccines Using Cross-Reactive Nanobodies |
| title_full_unstemmed | Development of an ELISA-Based Potency Assay for Inactivated Influenza Vaccines Using Cross-Reactive Nanobodies |
| title_short | Development of an ELISA-Based Potency Assay for Inactivated Influenza Vaccines Using Cross-Reactive Nanobodies |
| title_sort | development of an elisa based potency assay for inactivated influenza vaccines using cross reactive nanobodies |
| topic | influenza vaccine potency test nanobodies ELISA cross-reactive |
| url | https://www.mdpi.com/2076-393X/10/9/1473 |
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