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. 2018 May:255:84-90.
doi: 10.1016/j.jviromet.2018.02.018. Epub 2018 Feb 23.

Use of the Filovirus Animal Non-Clinical Group (FANG) Ebola virus immuno-assay requires fewer study participants to power a study than the Alpha Diagnostic International assay

James Logue  1 , Kaylie Tuznik  2 , Dean Follmann  3 , Greg Grandits  4 , Jonathan Marchand  2 , Cavan Reilly  4 , Yeya Dit Sadio Sarro  5 , James Pettitt  2 , Eric J Stavale  2 , Mosoka Fallah  6 , Gene G Olinger  2 , Fatorma K Bolay  6 , Lisa E Hensley  2
Affiliations

Use of the Filovirus Animal Non-Clinical Group (FANG) Ebola virus immuno-assay requires fewer study participants to power a study than the Alpha Diagnostic International assay

James Logue et al. J Virol Methods. 2018 May.

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.

Trial registration: ClinicalTrials.gov NCT02344407.

Keywords: ADI; Antibodies; ELISA; Ebola virus; FANG; Immune response; Serology.

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Figures

Fig. 1
Fig. 1
Rel[Ab] Range Comparison of relative antibody concentrations (rel[Ab]) by Alpha Diagnostics International enzyme-linked immunosorbent assay (ADI ELISA) or by Filovirus Animal Non-clinical Group (FANG) ELISA. Median and interquartile range of rel [Ab]s from two vaccine groups, rVSVΔG-ZEBOV-GP (red) and rChAd3-EBO-Z (blue), and placebo (gray).
Fig. 2
Fig. 2
Clinical Trial Vaccine Responses Histogram showing relative antibody concentrations rel[Ab] fold change from baseline in participants at 1-month post-vaccination using the FANG and ADI ELISAs.
Fig. 3
Fig. 3
Dilution Linearity Relative antibody concentrations (rel[Ab]) from successive dilutions of serum determined by each enzyme-linked immunosorbent assay (ELISA). The regression line of best fit for each assay are indicated by the solid blue lines. If the original line fit is not dilutionally linear, the dilutionally linear fit is shown in red. Additionally, the slope [90% confidence interval] is listed for each line fit.
See this image and copyright information in PMC

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