A monoclonal antibody‐based immunoassay for measuring the potency of 2009 pandemic influenza <scp>H</scp>1<scp>N</scp>1 vaccines

Schmeisser, Falko; Vasudevan, Anupama; Soto, Jackeline; Kumar, Arunima; Williams, Ollie; Weir, Jerry P.

doi:10.1111/irv.12272

Cited by 20 publications

(19 citation statements)

References 27 publications

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“…Correlation, but not always equivalence, between SRID potency and potency determined by alternative methods has been observed previously with most antibody-based assays, including our earlier work with influenza A H1N1 vaccines [22]. Our results in the present study indicated a relatively better correlation between SRID and B/Victoria mAb ELISA values than between the SRID and B/Yamagata mAb ELISA values.…”

Section: Discussionsupporting

confidence: 84%

Determination of influenza B identity and potency in quadrivalent inactivated influenza vaccines using lineage-specific monoclonal antibodies

et al. 2017

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Co-circulation of two antigenically and genetically distinct lineages of influenza B virus, represented by prototype viruses B/Victoria/2/1987 and B/Yamagata/16/1988, has led to the development of quadrivalent influenza vaccines that contain two influenza B antigens. The inclusion of two influenza B antigens presents challenges for the production and regulation of inactivated quadrivalent vaccines, including the potential for cross-reactivity of the reagents used in identity and potency assays because of the relative close relatedness of the hemagglutinin (HA) from the two virus lineages. Monoclonal antibodies (mAbs) specific for the two lineages of influenza B HA were generated and characterized and used to set-up simple identity tests that distinguish the influenza B antigens in inactivated trivalent and quadrivalent vaccines. The lineage-specific mAbs bound well to the HA of influenza B strains included in influenza vaccines over a period of more than 10 years, suggesting that identity tests using such lineage-specific mAbs would not necessarily have to be updated with every influenza B vaccine strain change. These lineage-specific mAbs were also used in an antibody capture ELISA format to quantify HA in vaccine samples, including monovalent, trivalent, and quadrivalent vaccine samples from various manufacturers. The results demonstrated correlation with HA values determined by the traditional single radial immunodiffusion (SRID) assay. Further, the antibody-capture ELISA was able to distinguish heat-stressed vaccine from unstressed vaccine, and was similar to the SRID in quantifying the resultant loss of potency. These mAb reagents should be useful for further development of antibody-based alternative influenza B identity and potency assays.

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Section: Discussionsupporting

confidence: 84%

Determination of influenza B identity and potency in quadrivalent inactivated influenza vaccines using lineage-specific monoclonal antibodies

et al. 2017

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“…The assay setup was similar to that previously described12 and used four different H7‐specific capture mAbs. ELISA potency values were determined by comparing the binding of HA in the vaccine samples relative to the binding of the reference antigen standard that has an assigned value in μg of HA.…”

Section: Resultsmentioning

confidence: 99%

“…Potency ELISAs were performed as previously described 12. Purified capture mAbs were used at a concentration of 2‐4 μg/mL (determined empirically for each mAb to optimize antigen capture and minimize non‐specific background).…”

Section: Methodsmentioning

confidence: 99%

“…In an attempt to address some of the limitations of the SRID, several newer methods have been explored in recent years as possible alternative potency assays for inactivated influenza vaccines 6, 7, 8, 9, 10, 11, 12, 13. Several of these assays rely on the use of strain‐specific monoclonal antibodies (mAbs) to capture and quantify HA in vaccine samples.…”

Section: Introductionmentioning

confidence: 99%

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Potency determination of inactivated H7 influenza vaccines using monoclonal antibody‐based ELISA and biolayer interferometry assays

Vasudevan

Woerner

Schmeisser

et al. 2017

Influenza Resp Viruses

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BackgroundThe single radial immunodiffusion (SRID) assay, the accepted method for determining potency of inactivated influenza vaccines, measures an immunogenic form of the influenza hemagglutinin. Nevertheless, alternative methods for measuring vaccine potency have been explored to address some of the weaknesses of the SRID assay, including limited sensitivity and the requirement for large amounts of standardized reagents. Monoclonal antibody (mAb)‐based potency assays also have the ability to detect and measure relevant immunogenic forms of HA.ObjectivesThe objective of this study was to continue evaluation of mAb‐based alternative methods for measuring the potency of inactivated influenza vaccines, focusing on A(H7N9) pandemic influenza vaccines.MethodsSeveral murine mAbs that recognize different epitopes on the H7 hemagglutinin (HA) were identified and characterized. These mAbs were evaluated in both a mAb‐capture ELISA and a mAb‐based biolayer interferometry (BLI) assay.ResultsResults indicated that potency of inactivated A(H7N9) vaccines, including vaccine samples that were stressed by heat treatment, measured by either alternative method correlated well with potency determined by the traditional SRID potency assay.ConclusionsThe availability of multiple H7 mAbs, directed to different HA epitopes, provides needed redundancy in the potency analysis as A(H7N9) viruses continue to evolve antigenically and suggests the importance of having a broad, well‐characterized panel of mAbs available for development of vaccines against influenza strains with pandemic potential. In addition, the results highlight the potential of mAb‐based platform such as ELISA and BLI for development as alternative methods for determining the potency of inactivated influenza vaccines.

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“…Universal antibodies that recognise all influenza subtypes have been described and used in an ELISA format to quantify HA, but these antibodies cannot distinguish influenza subtypes and may not be stability‐indicating because they bind HA under denaturing conditions 40. In other studies, strain‐specific mAbs have been used to quantify HA in capture ELISAs20, 41, 42; these assays are able to quantify each HA subtype antigen in multivalent vaccine formulations and are able to detect loss of potency in vaccine samples subjected to stress conditions. Another antibody‐binding platform under development as a possible potency assay uses panels of mAbs printed onto a slide format 43, 44.…”

Section: New Assay Developmentmentioning

confidence: 99%

Standardisation of inactivated influenza vaccines—Learning from history

Wood

Weir

2018

Influenza Resp Viruses

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The single radial immunodiffusion assay has been the accepted method for determining the potency of inactivated influenza vaccines since 1978. The worldwide adoption of this assay for vaccine standardisation was facilitated through collaborative studies that demonstrated a high level of reproducibility and its applicability to the different types of influenza vaccine being produced at that time. Clinical evidence indicated the relevance of SRID as a potency assay. Unique features of the SRID assay are likely responsible for its longevity even as newer technologies for vaccine characterisation have been developed and refined. Nevertheless, there are significant limitations to the SRID assay that indicate the need for improvement, and there has been a substantial amount of work undertaken in recent years to develop and evaluate alternative potency assays, including collaborative studies involving research laboratories, regulatory agencies and vaccine manufacturers. Here, we provide an overview of the history of inactivated influenza vaccine potency testing, the current state of alternative assay development and the some of the major challenges to be overcome before implementation of new assays for potency determination.

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A monoclonal antibody‐based immunoassay for measuring the potency of 2009 pandemic influenza H1N1 vaccines

Cited by 20 publications

References 27 publications

Determination of influenza B identity and potency in quadrivalent inactivated influenza vaccines using lineage-specific monoclonal antibodies

Determination of influenza B identity and potency in quadrivalent inactivated influenza vaccines using lineage-specific monoclonal antibodies

Potency determination of inactivated H7 influenza vaccines using monoclonal antibody‐based ELISA and biolayer interferometry assays

Standardisation of inactivated influenza vaccines—Learning from history

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