Validation of alternative potency assays for influenza vaccines requires clinical studies

Rowlen, Kathy L.

doi:10.1016/j.vaccine.2015.07.060

Cited by 8 publications

(7 citation statements)

References 2 publications

(2 reference statements)

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“…This would preclude the requirement for generating polyclonal antiserum from sheep against each circulating viruses. Furthermore, it has been acknowledged that the vaccine potency as determined by SRID could not provide an exact correlate between vaccine potency and the clinical outcome 49 . Although the SRID focuses on HA as the major protective antigen, there is growing awareness of the protective role of other influenza antigens including neuraminidase (NA) 50,51 or HA stalk as additional correlates of protection 7,52 .…”

Section: Discussionmentioning

confidence: 99%

Hemagglutinin Quantitative ELISA-based Potency Assay for Trivalent Seasonal Influenza Vaccine Using Group-Specific Universal Monoclonal Antibodies

Chae

Kim

et al. 2019

Sci Rep

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The assurance of vaccine potency is important for the timely release and distribution of influenza vaccines. As an alternative to Single Radial Immunodiffusion (SRID), we report a new quantitative enzyme-linked immunosorbent assay (ELISA) for seasonal trivalent influenza vaccine (TIV). The consensus hemagglutinin (cHA) stalks for group 1 influenza A virus (IAV), group 2 IAV, and influenza B virus (IBV) were designed and produced in bacterial recombinant host in a soluble form, and monoclonal antibodies (mAbs) were generated. The group-specific ‘universal’ mAbs (uAbs) bound to various subtypes of HAs in the same group from recombinant hosts, embryonated eggs, and commercial vaccine lots. The calibration curves were generated to assess the sensitivity, specificity, accuracy, and linear dynamic range. The quantitative ELISA was validated for the potency assay of individual components of TIV- H1, H3, and IBV- with good correlation with the SRID method. This new assay could be extended to pandemic or pre-pandemic mock-up vaccines of H5 of group 1 and H7 virus of group 2, and novel HA stalk-based universal vaccines.

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Section: Discussionmentioning

confidence: 99%

Hemagglutinin Quantitative ELISA-based Potency Assay for Trivalent Seasonal Influenza Vaccine Using Group-Specific Universal Monoclonal Antibodies

Chae

Kim

et al. 2019

Sci Rep

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“…It is not known whether this approach would provide a standard applicable to all types of vaccines or whether manufacturer-specific working standards would be needed. Alternatively, the possibility that new potency assays for influenza vaccines may need clinical trials to verify that potency determined by an alternative assay predicts vaccine efficacy has been proposed [39]. Clearly, additional studies will be needed to resolve such issues and determine the best way forward for development and implementation of alternative potency assays for influenza vaccines.…”

Section: Discussionmentioning

confidence: 99%

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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“…For example, there is great need to modernize the entire process of vaccine production for speed and efficiency. Current influenza vaccine release testing risk delaying vaccine availability regardless of speed of antigen manufacturing [49][50][51]. The ability to manufacture and release vaccine using robust potency tests as rapidly as possible is a key component of the pandemic influenza vaccine response [49].…”

Section: Improved Vaccine Availability (Faster)mentioning

confidence: 99%

Improving pandemic preparedness through better, faster influenza vaccines

Newland

Durham

Asher

et al. 2021

Expert Review of Vaccines

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Introduction. Timely availability of effective influenza vaccine will be critical to mitigate the next influenza pandemic. The mission of Biomedical Advanced Research and Development Authority (BARDA) is to develop medical countermeasures against pandemics, including influenza and other health security threats. Areas covered. Despite considerable gains in pandemic vaccine preparedness since 2009, old and new challenges threaten the pandemic influenza response capabilities of the U.S. Government: insufficient U.S.-based vaccine production, two-dose vaccination regimen, logistically complex adjuvanted formulation, and sustained surge manufacturing capacity despite no commercial market for pandemic vaccines. Although the coronavirus disease 2019 (COVID-19) pandemic has re-exposed these gaps in preparedness and response, previous investments into flexible influenza vaccine technologies proved to be critical to accelerate COVID-19 vaccine development. Expert opinion. BARDA addresses these challenges by implementing a pandemic influenza vaccine strategy with two key goals: 1) accelerating vaccine development and production (faster) and 2) improving vaccine performance (better). This strategy involves an end-to-end approach, including increasing manufacturing and fill-finish capacity; improving release testing speed; and funding clinical trials to improve current vaccine utilization. As demonstrated by the COVID-19 response, continued investments into this pandemic influenza vaccine strategy will further enhance the ability to respond to future emerging pandemic pathogens.

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Validation of alternative potency assays for influenza vaccines requires clinical studies

Cited by 8 publications

References 2 publications

Hemagglutinin Quantitative ELISA-based Potency Assay for Trivalent Seasonal Influenza Vaccine Using Group-Specific Universal Monoclonal Antibodies

Hemagglutinin Quantitative ELISA-based Potency Assay for Trivalent Seasonal Influenza Vaccine Using Group-Specific Universal Monoclonal Antibodies

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

Improving pandemic preparedness through better, faster influenza vaccines

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