Development of an enzyme‐linked immunoassay for the quantitation of influenza haemagglutinin: an alternative method to single radial immunodiffusion

Bodle, Jesse; Verity, Erin E.; Ong, Chi Wi; Vandenberg, Kirsten; Shaw, Robert; Barr, Ian G.; Rockman, Steven

doi:10.1111/j.1750-2659.2012.00375.x

Cited by 40 publications

(42 citation statements)

References 17 publications

(27 reference statements)

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“…Other studies have also evaluated the feasibility of an ELISA approach to determining influenza vaccine potency . Indeed, the idea of using a mAb‐based ELISA as a potency assay for inactivated influenza vaccines was proposed nearly 30 years ago .…”

Section: Discussionmentioning

confidence: 99%

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

Schmeisser

Vasudevan

Soto

et al. 2014

Influenza Resp Viruses

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BackgroundThe potency of inactivated influenza vaccines is determined using a single radial immunodiffusion (SRID) assay. This assay is relatively easy to standardize, it is not technically demanding, and it is capable of measuring the potency of several vaccine strain subtypes in a multivalent vaccine. Nevertheless, alternative methods that retain the major advantages of the SRID, but with a greater dynamic range of measurement and with reduced reagent requirements, are needed.ObjectivesThe feasibility of an ELISA-based assay format was explored as an alternative potency assay for inactivated influenza vaccines.MethodsSeveral murine monoclonal antibodies (mAbs), specific for the 2009 pandemic H1N1 influenza virus hemagglutinin (HA), were evaluated for their potential to capture and quantify HA antigen. Vaccine samples, obtained from four licensed influenza vaccine manufacturers, included monovalent bulk vaccine, monovalent vaccine, and trivalent vaccine. Traditional SRID potency assays were run in parallel with the mAb–ELISA potency assay using the reference antigen standard appropriate for the vaccine samples being tested.ResultsThe results indicated that the ELISA potency assay can quantify HA over a wide range of concentrations, including vaccine at subpotent doses, and the ELISA and SRID potency values correlated well for most vaccine samples. Importantly, the assay was capable of quantifying A/California HA in a trivalent formulation.ConclusionsThis study demonstrates the general feasibility of the mAb approach and strongly suggests that such ELISAs have potential for continued development as an alternative method to assay the potency of inactivated influenza vaccines.

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Section: Discussionmentioning

confidence: 99%

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

Schmeisser

Vasudevan

Soto

et al. 2014

Influenza Resp Viruses

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“…NA activity was determined using an enzyme-linked microplate assay where Arachis hypogaea (peanut) lectin labeled with horseradish peroxidase was used to detect ␤-D-galactose-N-acetylglucosamine sequences exposed after the removal of sialic acid from fetuin, as described by Lambre et al (20). Enzymelinked immunosorbent assays (ELISAs) were performed on wells coated with detergent-solubilized purified virus preparations (21).…”

Section: Methodsmentioning

confidence: 99%

Neuraminidase-Inhibiting Antibody Is a Correlate of Cross-Protection against Lethal H5N1 Influenza Virus in Ferrets Immunized with Seasonal Influenza Vaccine

Rockman

Brown

Barr

et al. 2013

J Virol

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eIn preparing for the threat of a pandemic of avian H5N1 influenza virus, we need to consider the significant delay (4 to 6 months) necessary to produce a strain-matched vaccine. As some degree of cross-reactivity between seasonal influenza vaccines and H5N1 virus has been reported, this was further explored in the ferret model to determine the targets of protective immunity. Ferrets were vaccinated with two intramuscular inoculations of trivalent inactivated split influenza vaccine or subcomponent vaccines, with and without adjuvant, and later challenged with a lethal dose of A/Vietnam/1203/2004 (H5N1) influenza virus. We confirmed that vaccination with seasonal influenza vaccine afforded partial protection against lethal H5N1 challenge and showed that use of either AlPO 4 or Iscomatrix adjuvant with the vaccine resulted in complete protection against disease and death. The protection was due exclusively to the H1N1 vaccine component, and although the hemagglutinin contributed to protection, the dominant protective response was targeted toward the neuraminidase (NA) and correlated with sialic acid cleavage-inhibiting antibody titers. Purified heterologous NA formulated with Iscomatrix adjuvant was also protective. These results suggest that adjuvanted seasonal trivalent vaccine could be used as an interim measure to decrease morbidity and mortality from H5N1 prior to the availability of a specific vaccine. The data also highlight that an inducer of cross-protective immunity is the NA, a protein whose levels are not normally monitored in vaccines and whose capacity to induce immunity in recipients is not normally assessed.

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“…Therefore, they are non-conformational and do not distinguish HA that can elicit protective antibodies (immunologically active HA) from misfolded or denatured HA that is unlikely to elicit potently protective immune responses. Antibodydependent assays, such as ELISA 21,22 and surface plasmon resonance, 23 can distinguish immunologically active HA if conformationally specific antibodies to certain regions are used. However, when a strain change occurs, new antibodies would often need to be generated and characterized, slowing vaccine release as occurs today.…”

Section: Alternative Potency Assaysmentioning

confidence: 99%

Bringing influenza vaccines into the 21st century

Settembre

Dormitzer

Rappuoli

2013

Human Vaccines & Immunotherapeutics

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T he recent H7N9 influenza outbreak in China highlights the need for influenza vaccine production systems that are robust and can quickly generate substantial quantities of vaccines that target new strains for pandemic and seasonal immunization. Although the influenza vaccine system, a public-private partnership, has been effective in providing vaccines, there are areas for improvement. Technological advances such as mammalian cell culture production and synthetic vaccine seeds provide a means to increase the speed and accuracy of targeting new influenza strains with mass-produced vaccines by dispensing with the need for egg isolation, adaptation, and reassortment of vaccine viruses. New influenza potency assays that no longer require the time-consuming step of generating sheep antisera could further speed vaccine release. Adjuvants that increase the breadth of the elicited immune response and allow dose sparing provide an additional means to increase the number of available vaccine doses. Together these technologies can improve the influenza vaccination system in the near term. In the longer term, disruptive technologies, such as RNA-based flu vaccines and 'universal' flu vaccines, offer a promise of a dramatically improved influenza vaccine system.

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Development of an enzyme‐linked immunoassay for the quantitation of influenza haemagglutinin: an alternative method to single radial immunodiffusion

Cited by 40 publications

References 17 publications

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

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

Neuraminidase-Inhibiting Antibody Is a Correlate of Cross-Protection against Lethal H5N1 Influenza Virus in Ferrets Immunized with Seasonal Influenza Vaccine

Bringing influenza vaccines into the 21st century

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