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Single-Shot ChAd3-MARV Vaccine in Modified Formulation Buffer Shows 100% Protection of NHPs

Marburg virus (MARV) is a virus of high human consequence with a case fatality rate of 24–88%. The global health and national security risks posed by Marburg virus disease (MVD) underscore the compelling need for a prophylactic vaccine, but no candidate has yet reached regulatory approval. Here, we...

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Autores principales: Finch, Courtney L., King, Thomas H., Alfson, Kendra J., Albanese, Katie A., Smith, Julianne N. P., Smock, Paul, Jakubik, Jocelyn, Goez-Gazi, Yenny, Gazi, Michal, Dutton, John W., Clemmons, Elizabeth A., Mattix, Marc E., Carrion, Ricardo, Rudge, Thomas, Ridenour, Alex, Woodin, Sovann F., Hunegnaw, Ruth, Sullivan, Nancy J., Xu, Rong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9694189/
https://www.ncbi.nlm.nih.gov/pubmed/36423030
http://dx.doi.org/10.3390/vaccines10111935
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author Finch, Courtney L.
King, Thomas H.
Alfson, Kendra J.
Albanese, Katie A.
Smith, Julianne N. P.
Smock, Paul
Jakubik, Jocelyn
Goez-Gazi, Yenny
Gazi, Michal
Dutton, John W.
Clemmons, Elizabeth A.
Mattix, Marc E.
Carrion, Ricardo
Rudge, Thomas
Ridenour, Alex
Woodin, Sovann F.
Hunegnaw, Ruth
Sullivan, Nancy J.
Xu, Rong
author_facet Finch, Courtney L.
King, Thomas H.
Alfson, Kendra J.
Albanese, Katie A.
Smith, Julianne N. P.
Smock, Paul
Jakubik, Jocelyn
Goez-Gazi, Yenny
Gazi, Michal
Dutton, John W.
Clemmons, Elizabeth A.
Mattix, Marc E.
Carrion, Ricardo
Rudge, Thomas
Ridenour, Alex
Woodin, Sovann F.
Hunegnaw, Ruth
Sullivan, Nancy J.
Xu, Rong
author_sort Finch, Courtney L.
collection PubMed
description Marburg virus (MARV) is a virus of high human consequence with a case fatality rate of 24–88%. The global health and national security risks posed by Marburg virus disease (MVD) underscore the compelling need for a prophylactic vaccine, but no candidate has yet reached regulatory approval. Here, we evaluate a replication-defective chimpanzee adenovirus type 3 (ChAd3)-vectored MARV Angola glycoprotein (GP)-expressing vaccine against lethal MARV challenge in macaques. The ChAd3 platform has previously been reported to protect against the MARV-related viruses, Ebola virus (EBOV) and Sudan virus (SUDV), and MARV itself in macaques, with immunogenicity demonstrated in macaques and humans. In this study, we present data showing 100% protection against MARV Angola challenge (versus 0% control survival) and associated production of GP-specific IgGs generated by the ChAd3-MARV vaccine following a single dose of 1 × 10(11) virus particles prepared in a new clinical formulation buffer designed to enhance product stability. These results are consistent with previously described data using the same vaccine in a different formulation and laboratory, demonstrating the reproducible and robust protective efficacy elicited by this promising vaccine for the prevention of MVD. Additionally, a qualified anti-GP MARV IgG ELISA was developed as a critical pre-requisite for clinical advancement and regulatory approval.
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spelling pubmed-96941892022-11-26 Single-Shot ChAd3-MARV Vaccine in Modified Formulation Buffer Shows 100% Protection of NHPs Finch, Courtney L. King, Thomas H. Alfson, Kendra J. Albanese, Katie A. Smith, Julianne N. P. Smock, Paul Jakubik, Jocelyn Goez-Gazi, Yenny Gazi, Michal Dutton, John W. Clemmons, Elizabeth A. Mattix, Marc E. Carrion, Ricardo Rudge, Thomas Ridenour, Alex Woodin, Sovann F. Hunegnaw, Ruth Sullivan, Nancy J. Xu, Rong Vaccines (Basel) Article Marburg virus (MARV) is a virus of high human consequence with a case fatality rate of 24–88%. The global health and national security risks posed by Marburg virus disease (MVD) underscore the compelling need for a prophylactic vaccine, but no candidate has yet reached regulatory approval. Here, we evaluate a replication-defective chimpanzee adenovirus type 3 (ChAd3)-vectored MARV Angola glycoprotein (GP)-expressing vaccine against lethal MARV challenge in macaques. The ChAd3 platform has previously been reported to protect against the MARV-related viruses, Ebola virus (EBOV) and Sudan virus (SUDV), and MARV itself in macaques, with immunogenicity demonstrated in macaques and humans. In this study, we present data showing 100% protection against MARV Angola challenge (versus 0% control survival) and associated production of GP-specific IgGs generated by the ChAd3-MARV vaccine following a single dose of 1 × 10(11) virus particles prepared in a new clinical formulation buffer designed to enhance product stability. These results are consistent with previously described data using the same vaccine in a different formulation and laboratory, demonstrating the reproducible and robust protective efficacy elicited by this promising vaccine for the prevention of MVD. Additionally, a qualified anti-GP MARV IgG ELISA was developed as a critical pre-requisite for clinical advancement and regulatory approval. MDPI 2022-11-15 /pmc/articles/PMC9694189/ /pubmed/36423030 http://dx.doi.org/10.3390/vaccines10111935 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
Finch, Courtney L.
King, Thomas H.
Alfson, Kendra J.
Albanese, Katie A.
Smith, Julianne N. P.
Smock, Paul
Jakubik, Jocelyn
Goez-Gazi, Yenny
Gazi, Michal
Dutton, John W.
Clemmons, Elizabeth A.
Mattix, Marc E.
Carrion, Ricardo
Rudge, Thomas
Ridenour, Alex
Woodin, Sovann F.
Hunegnaw, Ruth
Sullivan, Nancy J.
Xu, Rong
Single-Shot ChAd3-MARV Vaccine in Modified Formulation Buffer Shows 100% Protection of NHPs
title Single-Shot ChAd3-MARV Vaccine in Modified Formulation Buffer Shows 100% Protection of NHPs
title_full Single-Shot ChAd3-MARV Vaccine in Modified Formulation Buffer Shows 100% Protection of NHPs
title_fullStr Single-Shot ChAd3-MARV Vaccine in Modified Formulation Buffer Shows 100% Protection of NHPs
title_full_unstemmed Single-Shot ChAd3-MARV Vaccine in Modified Formulation Buffer Shows 100% Protection of NHPs
title_short Single-Shot ChAd3-MARV Vaccine in Modified Formulation Buffer Shows 100% Protection of NHPs
title_sort single-shot chad3-marv vaccine in modified formulation buffer shows 100% protection of nhps
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9694189/
https://www.ncbi.nlm.nih.gov/pubmed/36423030
http://dx.doi.org/10.3390/vaccines10111935
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