Vaccine immunogenicity assays are needed to assess the safety and efficacy of the candidate vaccine, by measuring humoral and cellular immune responses, in an effort to correlate with immunity.
At Viracor we develop and perform a variety of molecular assays for virus detection, and other assays for characterizing the humoral and cellular immune response, as part of clinical studies for our clients and their vaccine candidates.
- assays for the detection of one or more anti-drug antibodies (ADAs).
- neutralizing antibody assays to characterize neutralizing activity of ADAs, due to their potential impact on pharmacokinetics, pharmacodynamics, safety, and efficacy
- CD4/CD8 quantitation, B-cell response, cytokine release, and other activation assays
- qPCR assays to detect and quantify the presence of the virus in subject samples, as well as discrimination assays to differentiate wild type virus from vaccine strains
- TCID50 (50% tissue culture infective dose) assays
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