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.
Bibliographical noteFunding Information:
The authors acknowledge funding by the National Institutes of Allergy and Infectious Diseases ; ClinicalTrials.gov number, NCT02344407. The content of this publication does not necessarily reflect the views or policies of the US Department of Health and Human Services (DHHS) or of the institutions and companies affiliated with the authors. This work was funded in part through Battelle Memorial Institute’s prime contract with the US National Institute of Allergy and Infectious Diseases (NIAID) under Contract No. HHSN272200700016I. J.L., K.T., J.P., E.J.S. and J.M. performed this work as employees of Battelle Memorial Institute. A subcontractor to Battelle Memorial Institute who performed this work is: G.G.O, an employee of MRI Global.
The protocol used in this clinical vaccine trial was approved by the National Research Ethics Board of Liberia, National Cancer Institute institutional review board, the Liberian Medicines and Health Products Regulatory Authority, and the Food and Drug Administration. Written informed consent was obtained from all the participants.
- Ebola virus
- Immune response