Currently, the assay to measure immunogenicity of a flu vaccine are serologically based hemagglutinin inhibition and microneutralization assays. The assay results vary from inter and intra laboratories making it difficult to compare results across multiple sites. PI has made progress in standardizing the qPCR based neutralization assay and needs an additional year to qualify and test the assay using human samples and compare it to the currently used method (comparability studies). The assay will allow for quantitation of results which could be compared across multiple sites using standardized reagents and could have regulatory impact since results from clinical trials evaluating different vaccine candidates can be compared globally.
