Open AccessA monoclonal antibody‐based immunoassay for measuring the potency of 2009 pandemic influenza H 1 N 1 vaccines
Author(s) -
Schmeisser Falko,
Vasudevan Anupama,
Soto Jackeline,
Kumar Arunima,
Williams Ollie,
Weir Jerry P.
Publication year - 2014
Publication title -
influenza and other respiratory viruses
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.743
H-Index - 57
eISSN - 1750-2659
pISSN - 1750-2640
DOI - 10.1111/irv.12272
Subject(s) - potency , influenza vaccine , virology , radial immunodiffusion , monoclonal antibody , hemagglutinin (influenza) , antigen , immunoassay , influenza a virus , antibody , vaccine efficacy , trivalent influenza vaccine , virus , medicine , chemistry , vaccination , immunology , in vitro , biochemistry
Background The 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. Objectives The feasibility of an ELISA ‐based assay format was explored as an alternative potency assay for inactivated influenza vaccines. Methods Several murine monoclonal antibodies (mAbs), specific for the 2009 pandemic H 1 N 1 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. Results The 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. Conclusions This study demonstrates the general feasibility of the mAb approach and strongly suggests that such ELISA s have potential for continued development as an alternative method to assay the potency of inactivated influenza vaccines.