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Assays for the Evaluation of the Immune Response to Marburg and Ebola Sudan Vaccination—Filovirus Animal Nonclinical Group Anti-Marburg Virus Glycoprotein Immunoglobulin G Enzyme-Linked Immunosorbent Assay and a Pseudovirion Neutralization Assay
Since the discovery of the Marburg virus (MARV) in 1967 and Ebola virus (EBOV) in 1976, there have been over 40 reported outbreaks of filovirus disease with case fatality rates greater than 50%. This underscores the need for efficacious vaccines against these highly pathogenic filoviruses. Due to th...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9413256/ https://www.ncbi.nlm.nih.gov/pubmed/36016099 http://dx.doi.org/10.3390/vaccines10081211 |
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author | Rudge, Thomas L. Machesky, Nicholas J. Sankovich, Karen A. Lemmon, Erin E. Badorrek, Christopher S. Overman, Rachel Niemuth, Nancy A. Anderson, Michael S. |
author_facet | Rudge, Thomas L. Machesky, Nicholas J. Sankovich, Karen A. Lemmon, Erin E. Badorrek, Christopher S. Overman, Rachel Niemuth, Nancy A. Anderson, Michael S. |
author_sort | Rudge, Thomas L. |
collection | PubMed |
description | Since the discovery of the Marburg virus (MARV) in 1967 and Ebola virus (EBOV) in 1976, there have been over 40 reported outbreaks of filovirus disease with case fatality rates greater than 50%. This underscores the need for efficacious vaccines against these highly pathogenic filoviruses. Due to the sporadic and unpredictable nature of filovirus outbreaks, such a vaccine would likely need to be vetted through the U.S. Food and Drug Administration (FDA), following the Animal Rule or similar European Medicines Agency (EMA) regulatory pathway. Under the FDA Animal Rule, vaccine-induced immune responses correlating with survival of non-human primates (NHPs), or another well-characterized animal model, following lethal challenge, will need to be bridged for human immune response distributions in clinical trials. A correlate of protection has not yet been identified for the filovirus disease, but antibodies, specifically anti-glycoprotein (GP) antibodies, are believed to be critical in providing protection against the filovirus disease following vaccination and are thus a strong candidate for a correlate of protection. Thus, species-neutral methods capable of the detection and bridging of these antibody immune responses, such as methods to quantify anti-GP immunoglobulin G (IgG)-binding antibodies and neutralizing antibodies, are needed. Reported here is the development and qualification of two Filovirus Animal Nonclinical Group (FANG) anti-GP IgG Enzyme-Linked Immunosorbent Assays (ELISAs) to quantify anti-MARV and anti-Sudan virus (SUDV) IgG antibodies in human and NHP serum samples, as well as the development of pseudovirion neutralization assays (PsVNAs) to quantify MARV- and SUDV-neutralizing antibodies in human and NHP serum samples. |
format | Online Article Text |
id | pubmed-9413256 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-94132562022-08-27 Assays for the Evaluation of the Immune Response to Marburg and Ebola Sudan Vaccination—Filovirus Animal Nonclinical Group Anti-Marburg Virus Glycoprotein Immunoglobulin G Enzyme-Linked Immunosorbent Assay and a Pseudovirion Neutralization Assay Rudge, Thomas L. Machesky, Nicholas J. Sankovich, Karen A. Lemmon, Erin E. Badorrek, Christopher S. Overman, Rachel Niemuth, Nancy A. Anderson, Michael S. Vaccines (Basel) Article Since the discovery of the Marburg virus (MARV) in 1967 and Ebola virus (EBOV) in 1976, there have been over 40 reported outbreaks of filovirus disease with case fatality rates greater than 50%. This underscores the need for efficacious vaccines against these highly pathogenic filoviruses. Due to the sporadic and unpredictable nature of filovirus outbreaks, such a vaccine would likely need to be vetted through the U.S. Food and Drug Administration (FDA), following the Animal Rule or similar European Medicines Agency (EMA) regulatory pathway. Under the FDA Animal Rule, vaccine-induced immune responses correlating with survival of non-human primates (NHPs), or another well-characterized animal model, following lethal challenge, will need to be bridged for human immune response distributions in clinical trials. A correlate of protection has not yet been identified for the filovirus disease, but antibodies, specifically anti-glycoprotein (GP) antibodies, are believed to be critical in providing protection against the filovirus disease following vaccination and are thus a strong candidate for a correlate of protection. Thus, species-neutral methods capable of the detection and bridging of these antibody immune responses, such as methods to quantify anti-GP immunoglobulin G (IgG)-binding antibodies and neutralizing antibodies, are needed. Reported here is the development and qualification of two Filovirus Animal Nonclinical Group (FANG) anti-GP IgG Enzyme-Linked Immunosorbent Assays (ELISAs) to quantify anti-MARV and anti-Sudan virus (SUDV) IgG antibodies in human and NHP serum samples, as well as the development of pseudovirion neutralization assays (PsVNAs) to quantify MARV- and SUDV-neutralizing antibodies in human and NHP serum samples. MDPI 2022-07-29 /pmc/articles/PMC9413256/ /pubmed/36016099 http://dx.doi.org/10.3390/vaccines10081211 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Rudge, Thomas L. Machesky, Nicholas J. Sankovich, Karen A. Lemmon, Erin E. Badorrek, Christopher S. Overman, Rachel Niemuth, Nancy A. Anderson, Michael S. Assays for the Evaluation of the Immune Response to Marburg and Ebola Sudan Vaccination—Filovirus Animal Nonclinical Group Anti-Marburg Virus Glycoprotein Immunoglobulin G Enzyme-Linked Immunosorbent Assay and a Pseudovirion Neutralization Assay |
title | Assays for the Evaluation of the Immune Response to Marburg and Ebola Sudan Vaccination—Filovirus Animal Nonclinical Group Anti-Marburg Virus Glycoprotein Immunoglobulin G Enzyme-Linked Immunosorbent Assay and a Pseudovirion Neutralization Assay |
title_full | Assays for the Evaluation of the Immune Response to Marburg and Ebola Sudan Vaccination—Filovirus Animal Nonclinical Group Anti-Marburg Virus Glycoprotein Immunoglobulin G Enzyme-Linked Immunosorbent Assay and a Pseudovirion Neutralization Assay |
title_fullStr | Assays for the Evaluation of the Immune Response to Marburg and Ebola Sudan Vaccination—Filovirus Animal Nonclinical Group Anti-Marburg Virus Glycoprotein Immunoglobulin G Enzyme-Linked Immunosorbent Assay and a Pseudovirion Neutralization Assay |
title_full_unstemmed | Assays for the Evaluation of the Immune Response to Marburg and Ebola Sudan Vaccination—Filovirus Animal Nonclinical Group Anti-Marburg Virus Glycoprotein Immunoglobulin G Enzyme-Linked Immunosorbent Assay and a Pseudovirion Neutralization Assay |
title_short | Assays for the Evaluation of the Immune Response to Marburg and Ebola Sudan Vaccination—Filovirus Animal Nonclinical Group Anti-Marburg Virus Glycoprotein Immunoglobulin G Enzyme-Linked Immunosorbent Assay and a Pseudovirion Neutralization Assay |
title_sort | assays for the evaluation of the immune response to marburg and ebola sudan vaccination—filovirus animal nonclinical group anti-marburg virus glycoprotein immunoglobulin g enzyme-linked immunosorbent assay and a pseudovirion neutralization assay |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9413256/ https://www.ncbi.nlm.nih.gov/pubmed/36016099 http://dx.doi.org/10.3390/vaccines10081211 |
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