Cryopreservation-related loss of antigen-specific IFNγ producing CD4⁺ T-cells can skew immunogenicity data in vaccine trials: Lessons from a malaria vaccine trial substudy.

ABSTRACT: Ex vivo functional immunoassays such as ELISpot and intracellular cytokine staining (ICS) by flow cytometry are crucial tools in vaccine development both in the identification of novel immunogenic targets and in the immunological assessment of samples from clinical trials. Cryopreservation and subsequent thawing of PBMCs via validated processes has become a mainstay of clinical trials due to processing restrictions inherent in the disparate location and capacity of trial centres, and also in the need to standardize biological assays at central testing facilities. Logistical and financial requirement to batch process samples from multiple study timepoints are also key. We used ELISpot and ICS assays to assess antigen-specific immunogenicity in blood samples taken from subjects enrolled in a

SUBMITTER: Ford T 

PROVIDER: S-EPMC5387668 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature