Abstract
As part of the scientific community’s development of medical countermeasures against Ebola virus disease, optimization of standardized assays for product evaluation is paramount. The recent outbreak heightened awareness to the scarcity of available assays and limited information on performance and reproducibility. To evaluate the immunogenicity of vaccines entering Phase I–III trials and to identify survivors, two enzyme-linked immunosorbent assays, the Filovirus Animal Non-Clinical Group assay and the Alpha Diagnostics International assay, were evaluated for detection of immunoglobulin G against Ebola virus glycoprotein. We found that the Filovirus Animal Nonclinical Group assay produced a wider range of relative antibody concentrations, higher assay precision, larger relative accuracy range, and lower regional background. Additionally, to sufficiently power a vaccine trial, use of the Filovirus Animal Nonclinical Group assay would require one third the number of participants than the Alpha Diagnostics International assay. This reduction in needed study participants will require less money, fewer man hours, and much less time to evaluate vaccine immunogenicity.
Highlights
Over 11,000 individuals succumbed to the recent and largest Ebola virus disease (EVD) outbreak that occurred in Western Africa (World Health Organization, 2016c; World Health Organization, 2016b)
The median and interquartile ranges (IQR) rel[Ab] humoral vaccine responses for both active vaccine groups observed at 1 month were greater in the samples tested by the Filovirus Animal Nonclinical Group (FANG) enzyme-linked immunosorbent assays (ELISAs) than when these samples were tested by the Alpha Diagnostic International (ADI) ELISA (p < 0.001 between FANG and ADI for both vaccine groups individually)
As made evident by the PREVAIL I vaccine data set, the rel[Ab] range of the FANG ELISA exceeds the range of the ADI assay, allowing an investigator to better compare vaccine responses
Summary
Over 11,000 individuals succumbed to the recent and largest Ebola virus disease (EVD) outbreak that occurred in Western Africa (World Health Organization, 2016c; World Health Organization, 2016b). Though many individuals recovered from disease, clear evidence demonstrates that Ebola virus (EBOV) can persist in EVD survivors long after signs and symptoms have subsided (MacDermott and Bausch, 2016; World Health Organization, 2016a). Though the outbreak has ended, countermeasures should be developed to combat any potential reintroductions of EVD into the population by these or other traditional transmission routes. Paramount to these countermeasures is an effective and long-lasting vaccine
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