Development and characterization of a Zaire Ebola (ZEBOV) specific IgM ELISA

J Immunol Methods. 2019 May;468:29-34. doi: 10.1016/j.jim.2019.03.008. Epub 2019 Mar 22.

Abstract

Immunoglobulin M (IgM) is the first antibody induced after the onset of an adaptive immune response against a pathogen or vaccine. Serological assays play a central role in evaluating these adaptive immunological responses. Such assays are not only crucial for the assessment of vaccine immunogenicity, but also inform on exposure to pathogens and cross-reactivity with other viruses. To date, there is no ELISA-based assay available that measures IgM responses against Zaire Ebola virus (ZEBOV). To address this critical need, our laboratory has developed a novel immunoassay capable of detecting total IgM against ZEBOV glycoprotein in serum samples from individuals exposed to the antigen through infection or vaccination. Here, we describe a sensitive, high-throughput, and inexpensive assay that can be performed in any laboratory. The performance criteria of the newly developed ZEBOV glycoprotein-based IgM ELISA were assessed using antisera collected from human patients immunized with the rVSVΔG-ZEBOV-GP vaccine being tested in a phase 1 clinical trial. This assay demonstrates high specificity and sensitivity and will also be a valuable tool in the mission to find immune correlates of protection for a successful Ebola vaccine.

Keywords: Assay development; Correlates of protection; ELISA; IgM; Vaccine; Zaire Ebola virus.

Publication types

  • Evaluation Study
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Antibodies, Viral / blood*
  • Biomarkers / blood
  • Clinical Trials, Phase I as Topic
  • Ebola Vaccines / administration & dosage*
  • Ebola Vaccines / immunology
  • Ebolavirus / immunology*
  • Enzyme-Linked Immunosorbent Assay*
  • Hemorrhagic Fever, Ebola / blood
  • Hemorrhagic Fever, Ebola / immunology
  • Hemorrhagic Fever, Ebola / prevention & control*
  • Hemorrhagic Fever, Ebola / virology
  • Humans
  • Immunization
  • Immunogenicity, Vaccine*
  • Immunoglobulin M / blood*
  • Predictive Value of Tests
  • Reproducibility of Results
  • Serologic Tests*
  • Time Factors
  • Treatment Outcome

Substances

  • Antibodies, Viral
  • Biomarkers
  • Ebola Vaccines
  • Immunoglobulin M