BOULDER COLORADO (4/25/18) — "VaxArray for Hemagglutinin and Neuraminidase Potency Testing of Influenza Vaccines" describes a study designed to test the relationship between VaxArray-measured potency and vaccine-induced immunogenicity in mice. The study results represent a milestone in an industry-wide effort to qualify new potency assays for influenza vaccines.
For an A/H3N2 vaccine, the VaxArray neuraminidase (NA) potency assay was strongly correlated with enzymatic activity, highly sensitive to immunogenic forms of NA, and correlated with serum levels of NA inhibiting antibodies. In addition, the VaxArray hemagglutinin (HA) potency assay demonstrated equivalency to the current gold standard method and confirms the expected relationship to immunogenicity.
Although the authors acknowledge that more testing is needed, the consistent and predictive immunogenicity-potency relationships observed for VaxArray HA and NA support a conclusion that these assays can serve as a proxy for vaccine-induced immunogenicity and thereby are a measure the potency of the targeted antigen.
The effort was funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Human Services (HHS), under Contract Number HHSN272201200005I. Additional resource support for serologic testing was provided by CBER FDA.
Find more information about the entire VaxArray vaccine potency testing platform at: https://indevr.com/products/vaxarray/
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Vaccine is the pre-eminent journal for those interested in vaccines and vaccination. It is the official journal of The Edward Jenner Society and The Japanese Society for Vaccinology and is published by Elsevier http://www.elsevier.com/locate/vaccine
HHS is not responsible for the contents of this release. The statements contained in this release do not constitute endorsement or recommendation by the U.S. Government or HHS.
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