Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate

Abstract It has been proven challenging to conduct traditional efficacy trials for Ebola virus (EBOV) vaccines. In the absence of efficacy data, immunobridging is an approach to infer the likelihood of a vaccine protective effect, by translating vaccine immunogenicity in humans to a protective effec...

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Autores principales:	Ramon Roozendaal, Jenny Hendriks, Thierry van Effelterre, Bart Spiessens, Liesbeth Dekking, Laura Solforosi, Dominika Czapska-Casey, Viki Bockstal, Jeroen Stoop, Daniel Splinter, Sarah Janssen, Ben van Baelen, Nadia Verbruggen, Jan Serroyen, Eline Dekeyster, Ariane Volkmann, Yvonne Wollmann, Ricardo Carrion, Luis D. Giavedoni, Cynthia Robinson, Maarten Leyssen, Macaya Douoguih, Kerstin Luhn, Maria Grazia Pau, Jerry Sadoff, An Vandebosch, Hanneke Schuitemaker, Roland Zahn, Benoit Callendret
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2020
Materias:	Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/31753f8ec19c4f7ca129201ac99ccb00
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spelling	oai:doaj.org-article:31753f8ec19c4f7ca129201ac99ccb002021-12-02T12:42:26ZNonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate10.1038/s41541-020-00261-92059-0105https://doaj.org/article/31753f8ec19c4f7ca129201ac99ccb002020-12-01T00:00:00Zhttps://doi.org/10.1038/s41541-020-00261-9https://doaj.org/toc/2059-0105Abstract It has been proven challenging to conduct traditional efficacy trials for Ebola virus (EBOV) vaccines. In the absence of efficacy data, immunobridging is an approach to infer the likelihood of a vaccine protective effect, by translating vaccine immunogenicity in humans to a protective effect, using the relationship between vaccine immunogenicity and the desired outcome in a suitable animal model. We here propose to infer the protective effect of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen with an 8-week interval in humans by immunobridging. Immunogenicity and protective efficacy data were obtained for Ad26.ZEBOV and MVA-BN-Filo vaccine regimens using a fully lethal EBOV Kikwit challenge model in cynomolgus monkeys (nonhuman primates [NHP]). The association between EBOV neutralizing antibodies, glycoprotein (GP)-binding antibodies, and GP-reactive T cells and survival in NHP was assessed by logistic regression analysis. Binding antibodies against the EBOV surface GP were identified as the immune parameter with the strongest correlation to survival post EBOV challenge, and used to infer the predicted protective effect of the vaccine in humans using published data from phase I studies. The human vaccine-elicited EBOV GP-binding antibody levels are in a range associated with significant protection against mortality in NHP. Based on this immunobridging analysis, the EBOV GP-specific-binding antibody levels elicited by the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen in humans will likely provide protection against EBOV disease.Ramon RoozendaalJenny HendriksThierry van EffelterreBart SpiessensLiesbeth DekkingLaura SolforosiDominika Czapska-CaseyViki BockstalJeroen StoopDaniel SplinterSarah JanssenBen van BaelenNadia VerbruggenJan SerroyenEline DekeysterAriane VolkmannYvonne WollmannRicardo CarrionLuis D. GiavedoniCynthia RobinsonMaarten LeyssenMacaya DouoguihKerstin LuhnMaria Grazia PauJerry SadoffAn VandeboschHanneke SchuitemakerRoland ZahnBenoit CallendretNature PortfolioarticleImmunologic diseases. AllergyRC581-607Neoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENnpj Vaccines, Vol 5, Iss 1, Pp 1-11 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Ramon Roozendaal Jenny Hendriks Thierry van Effelterre Bart Spiessens Liesbeth Dekking Laura Solforosi Dominika Czapska-Casey Viki Bockstal Jeroen Stoop Daniel Splinter Sarah Janssen Ben van Baelen Nadia Verbruggen Jan Serroyen Eline Dekeyster Ariane Volkmann Yvonne Wollmann Ricardo Carrion Luis D. Giavedoni Cynthia Robinson Maarten Leyssen Macaya Douoguih Kerstin Luhn Maria Grazia Pau Jerry Sadoff An Vandebosch Hanneke Schuitemaker Roland Zahn Benoit Callendret Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate
description	Abstract It has been proven challenging to conduct traditional efficacy trials for Ebola virus (EBOV) vaccines. In the absence of efficacy data, immunobridging is an approach to infer the likelihood of a vaccine protective effect, by translating vaccine immunogenicity in humans to a protective effect, using the relationship between vaccine immunogenicity and the desired outcome in a suitable animal model. We here propose to infer the protective effect of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen with an 8-week interval in humans by immunobridging. Immunogenicity and protective efficacy data were obtained for Ad26.ZEBOV and MVA-BN-Filo vaccine regimens using a fully lethal EBOV Kikwit challenge model in cynomolgus monkeys (nonhuman primates [NHP]). The association between EBOV neutralizing antibodies, glycoprotein (GP)-binding antibodies, and GP-reactive T cells and survival in NHP was assessed by logistic regression analysis. Binding antibodies against the EBOV surface GP were identified as the immune parameter with the strongest correlation to survival post EBOV challenge, and used to infer the predicted protective effect of the vaccine in humans using published data from phase I studies. The human vaccine-elicited EBOV GP-binding antibody levels are in a range associated with significant protection against mortality in NHP. Based on this immunobridging analysis, the EBOV GP-specific-binding antibody levels elicited by the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen in humans will likely provide protection against EBOV disease.
format	article
author	Ramon Roozendaal Jenny Hendriks Thierry van Effelterre Bart Spiessens Liesbeth Dekking Laura Solforosi Dominika Czapska-Casey Viki Bockstal Jeroen Stoop Daniel Splinter Sarah Janssen Ben van Baelen Nadia Verbruggen Jan Serroyen Eline Dekeyster Ariane Volkmann Yvonne Wollmann Ricardo Carrion Luis D. Giavedoni Cynthia Robinson Maarten Leyssen Macaya Douoguih Kerstin Luhn Maria Grazia Pau Jerry Sadoff An Vandebosch Hanneke Schuitemaker Roland Zahn Benoit Callendret
author_facet	Ramon Roozendaal Jenny Hendriks Thierry van Effelterre Bart Spiessens Liesbeth Dekking Laura Solforosi Dominika Czapska-Casey Viki Bockstal Jeroen Stoop Daniel Splinter Sarah Janssen Ben van Baelen Nadia Verbruggen Jan Serroyen Eline Dekeyster Ariane Volkmann Yvonne Wollmann Ricardo Carrion Luis D. Giavedoni Cynthia Robinson Maarten Leyssen Macaya Douoguih Kerstin Luhn Maria Grazia Pau Jerry Sadoff An Vandebosch Hanneke Schuitemaker Roland Zahn Benoit Callendret
author_sort	Ramon Roozendaal
title	Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate
title_short	Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate
title_full	Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate
title_fullStr	Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate
title_full_unstemmed	Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate
title_sort	nonhuman primate to human immunobridging to infer the protective effect of an ebola virus vaccine candidate
publisher	Nature Portfolio
publishDate	2020
url	https://doaj.org/article/31753f8ec19c4f7ca129201ac99ccb00
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Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate

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