Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development

Roberts, Christine C.

Many of the priority pathogens identified by WHO cause outbreaks that are difficult to predict and may be sporadic in nature. 1 This complicates efforts to establish processes ahead of any outbreak to collect valuable acute and convalescent samples from individuals naturally infected by the respective viruses. There was, and still is, a lack of well-characterized human specimens from naturally infected MERS-CoV and ZIKV subjects that vaccine development groups could use to for assay development and, eventually, to establish a recognized set of standards that can be maintained over time. 10 A potentially valuable source of relevant clinical samples is from ongoing epidemiological studies and clinical trials. Study designers should take care to incorporate proper language into the informed consents of participants to allow for the request of additional blood draws or sample collections and for the future use of their clinical samples for the purposes of standards and assay development. [14] [15] [16] Such studies should also ensure that well-established chain-of-custody, sample handling, and sample storage procedures are in place to maintain the quality of these valuable specimens. 17, 18 A significant drawback of this approach is that often the samples may not have adequate characterization, may be of limited volume, and are proprietary to the study sponsors. It should also be taken into account that local laws or culture may be prohibitive to allowing specimens to be stored for future testing. 16, [19] [20] [21] [22] [23] A concerted effort and willingness among researchers and companies to share available clinical specimens would be a valuable step forward in EID preparedness. 24 Sample collection & handling are critical to the quality of the specimen and its ability to be used in assays, standards or controls. 25 Even in vaccine studies conducted in developed nations, challenges to appropriate sample collection and handling can occur. We experienced an issue with the timing of specimen intake and handling at a biorepository used for our ZIKV trials which required immediate corrective action to de-risk samples collected at the remaining study time points and prior to initiation of a second study. Ensuring proper sample storage and shipping conditions, processing and aliquotting (with attention to contamination control), training of site and clinical research organization lab personnel, a clear chain of custody from collection to final application, intermediate quality control checks, and good data management is critical for collection of high quality samples that can be used in the future. 17, 26, 27 3. Vaccine clinical assays, reference reagents, international controls