Examining protective effects of SARS-CoV-2 neutralizing antibodies after vaccination or monoclonal antibody administration

While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not exist for preventative monoclonal antibodies. In this work, nAb titers were assessed as correlates of protection against COVID-19 in the cas...

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Published inNature communications Vol. 14; no. 1; pp. 3605 - 9
Main Authors Follmann, Dean, O’Brien, Meagan P., Fintzi, Jonathan, Fay, Michael P., Montefiori, David, Mateja, Allyson, Herman, Gary A., Hooper, Andrea T., Turner, Kenneth C., Chan, Kuo- Chen, Forleo-Neto, Eduardo, Isa, Flonza, Baden, Lindsey R., El Sahly, Hana M., Janes, Holly, Doria-Rose, Nicole, Miller, Jacqueline, Zhou, Honghong, Dang, Weiping, Benkeser, David, Fong, Youyi, Gilbert, Peter B., Marovich, Mary, Cohen, Myron S.
Format Journal Article
LanguageEnglish
Published London Nature Publishing Group UK 17.06.2023
Nature Publishing Group
Nature Portfolio
Subjects
2019-nCoV Vaccine mRNA-1273
631/250/2152/2153/1291
631/326/590/2293
631/326/596/4130
692/699/255/2514
Antibodies, Monoclonal
Antibodies, Neutralizing
Antibodies, Viral
Correlation
COVID-19
COVID-19 - prevention & control
COVID-19 Vaccines
Effectiveness
Humanities and Social Sciences
Humans
Monoclonal antibodies
mRNA
multidisciplinary
Neutralizing
Prevention
SARS-CoV-2
Science
Science (multidisciplinary)
Severe acute respiratory syndrome coronavirus 2
Vaccination
Vaccines
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Abstract While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not exist for preventative monoclonal antibodies. In this work, nAb titers were assessed as correlates of protection against COVID-19 in the casirivimab + imdevimab monoclonal antibody (mAb) prevention trial (ClinicalTrials.gov #NCT4452318) and in the mRNA-1273 vaccine trial (ClinicalTrials.gov #NCT04470427). In the mAb trial, protective efficacy of 92% (95% confidence interval (CI): 84%, 98%) is associated with a nAb titer of 1000 IU50/ml, with lower efficacy at lower nAb titers. In the vaccine trial, protective efficacies of 93% [95% CI: 91%, 95%] and 97% (95% CI: 95%, 98%) are associated with nAb titers of 100 and 1000 IU50/ml, respectively. These data quantitate a nAb titer correlate of protection for mAbs benchmarked alongside vaccine induced nAb titers and support nAb titer as a surrogate endpoint for authorizing new mAbs. Here the authors assess neutralizing antibody (nAb) levels as correlate of protection in a monoclonal antibody prevention trial and a vaccine trial for COVID-19 and show that nAb titers correlate with clinical protection against COVID-19 supporting nAb titer as a surrogate endpoint for authorization of monoclonal antibodies.
AbstractList Abstract While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not exist for preventative monoclonal antibodies. In this work, nAb titers were assessed as correlates of protection against COVID-19 in the casirivimab + imdevimab monoclonal antibody (mAb) prevention trial (ClinicalTrials.gov #NCT4452318) and in the mRNA-1273 vaccine trial (ClinicalTrials.gov #NCT04470427). In the mAb trial, protective efficacy of 92% (95% confidence interval (CI): 84%, 98%) is associated with a nAb titer of 1000 IU50/ml, with lower efficacy at lower nAb titers. In the vaccine trial, protective efficacies of 93% [95% CI: 91%, 95%] and 97% (95% CI: 95%, 98%) are associated with nAb titers of 100 and 1000 IU50/ml, respectively. These data quantitate a nAb titer correlate of protection for mAbs benchmarked alongside vaccine induced nAb titers and support nAb titer as a surrogate endpoint for authorizing new mAbs.
While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not exist for preventative monoclonal antibodies. In this work, nAb titers were assessed as correlates of protection against COVID-19 in the casirivimab + imdevimab monoclonal antibody (mAb) prevention trial (ClinicalTrials.gov #NCT4452318) and in the mRNA-1273 vaccine trial (ClinicalTrials.gov #NCT04470427). In the mAb trial, protective efficacy of 92% (95% confidence interval (CI): 84%, 98%) is associated with a nAb titer of 1000 IU50/ml, with lower efficacy at lower nAb titers. In the vaccine trial, protective efficacies of 93% [95% CI: 91%, 95%] and 97% (95% CI: 95%, 98%) are associated with nAb titers of 100 and 1000 IU50/ml, respectively. These data quantitate a nAb titer correlate of protection for mAbs benchmarked alongside vaccine induced nAb titers and support nAb titer as a surrogate endpoint for authorizing new mAbs.
While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not exist for preventative monoclonal antibodies. In this work, nAb titers were assessed as correlates of protection against COVID-19 in the casirivimab + imdevimab monoclonal antibody (mAb) prevention trial (ClinicalTrials.gov #NCT4452318) and in the mRNA-1273 vaccine trial (ClinicalTrials.gov #NCT04470427). In the mAb trial, protective efficacy of 92% (95% confidence interval (CI): 84%, 98%) is associated with a nAb titer of 1000 IU50/ml, with lower efficacy at lower nAb titers. In the vaccine trial, protective efficacies of 93% [95% CI: 91%, 95%] and 97% (95% CI: 95%, 98%) are associated with nAb titers of 100 and 1000 IU50/ml, respectively. These data quantitate a nAb titer correlate of protection for mAbs benchmarked alongside vaccine induced nAb titers and support nAb titer as a surrogate endpoint for authorizing new mAbs.While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not exist for preventative monoclonal antibodies. In this work, nAb titers were assessed as correlates of protection against COVID-19 in the casirivimab + imdevimab monoclonal antibody (mAb) prevention trial (ClinicalTrials.gov #NCT4452318) and in the mRNA-1273 vaccine trial (ClinicalTrials.gov #NCT04470427). In the mAb trial, protective efficacy of 92% (95% confidence interval (CI): 84%, 98%) is associated with a nAb titer of 1000 IU50/ml, with lower efficacy at lower nAb titers. In the vaccine trial, protective efficacies of 93% [95% CI: 91%, 95%] and 97% (95% CI: 95%, 98%) are associated with nAb titers of 100 and 1000 IU50/ml, respectively. These data quantitate a nAb titer correlate of protection for mAbs benchmarked alongside vaccine induced nAb titers and support nAb titer as a surrogate endpoint for authorizing new mAbs.
While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not exist for preventative monoclonal antibodies. In this work, nAb titers were assessed as correlates of protection against COVID-19 in the casirivimab + imdevimab monoclonal antibody (mAb) prevention trial (ClinicalTrials.gov #NCT4452318) and in the mRNA-1273 vaccine trial (ClinicalTrials.gov #NCT04470427). In the mAb trial, protective efficacy of 92% (95% confidence interval (CI): 84%, 98%) is associated with a nAb titer of 1000 IU50/ml, with lower efficacy at lower nAb titers. In the vaccine trial, protective efficacies of 93% [95% CI: 91%, 95%] and 97% (95% CI: 95%, 98%) are associated with nAb titers of 100 and 1000 IU50/ml, respectively. These data quantitate a nAb titer correlate of protection for mAbs benchmarked alongside vaccine induced nAb titers and support nAb titer as a surrogate endpoint for authorizing new mAbs.Here the authors assess neutralizing antibody (nAb) levels as correlate of protection in a monoclonal antibody prevention trial and a vaccine trial for COVID-19 and show that nAb titers correlate with clinical protection against COVID-19 supporting nAb titer as a surrogate endpoint for authorization of monoclonal antibodies.
While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not exist for preventative monoclonal antibodies. In this work, nAb titers were assessed as correlates of protection against COVID-19 in the casirivimab + imdevimab monoclonal antibody (mAb) prevention trial (ClinicalTrials.gov #NCT4452318) and in the mRNA-1273 vaccine trial (ClinicalTrials.gov #NCT04470427). In the mAb trial, protective efficacy of 92% (95% confidence interval (CI): 84%, 98%) is associated with a nAb titer of 1000 IU50/ml, with lower efficacy at lower nAb titers. In the vaccine trial, protective efficacies of 93% [95% CI: 91%, 95%] and 97% (95% CI: 95%, 98%) are associated with nAb titers of 100 and 1000 IU50/ml, respectively. These data quantitate a nAb titer correlate of protection for mAbs benchmarked alongside vaccine induced nAb titers and support nAb titer as a surrogate endpoint for authorizing new mAbs. Here the authors assess neutralizing antibody (nAb) levels as correlate of protection in a monoclonal antibody prevention trial and a vaccine trial for COVID-19 and show that nAb titers correlate with clinical protection against COVID-19 supporting nAb titer as a surrogate endpoint for authorization of monoclonal antibodies.
ArticleNumber 3605
Author Isa, Flonza
Follmann, Dean
Herman, Gary A.
Miller, Jacqueline
El Sahly, Hana M.
Fay, Michael P.
Dang, Weiping
Forleo-Neto, Eduardo
Gilbert, Peter B.
Baden, Lindsey R.
Zhou, Honghong
Fong, Youyi
Montefiori, David
Cohen, Myron S.
Benkeser, David
Chan, Kuo- Chen
Doria-Rose, Nicole
Hooper, Andrea T.
Janes, Holly
Fintzi, Jonathan
Turner, Kenneth C.
O’Brien, Meagan P.
Mateja, Allyson
Marovich, Mary
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/37330602$$D View this record in MEDLINE/PubMed
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Copyright This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply 2023
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Snippet While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not...
Abstract While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway...
SourceID doaj
pubmedcentral
proquest
pubmed
crossref
springer
SourceType Open Website
Open Access Repository
Aggregation Database
Index Database
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Publisher
StartPage 3605
SubjectTerms 2019-nCoV Vaccine mRNA-1273
631/250/2152/2153/1291
631/326/590/2293
631/326/596/4130
692/699/255/2514
Antibodies, Monoclonal
Antibodies, Neutralizing
Antibodies, Viral
Correlation
COVID-19
COVID-19 - prevention & control
COVID-19 Vaccines
Effectiveness
Humanities and Social Sciences
Humans
Monoclonal antibodies
mRNA
multidisciplinary
Neutralizing
Prevention
SARS-CoV-2
Science
Science (multidisciplinary)
Severe acute respiratory syndrome coronavirus 2
Vaccination
Vaccines
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Title Examining protective effects of SARS-CoV-2 neutralizing antibodies after vaccination or monoclonal antibody administration
URI https://link.springer.com/article/10.1038/s41467-023-39292-w
https://www.ncbi.nlm.nih.gov/pubmed/37330602
https://www.proquest.com/docview/2827014221
https://www.proquest.com/docview/2827257073
https://pubmed.ncbi.nlm.nih.gov/PMC10276829
https://doaj.org/article/f53522c4468546fb9a6f21698f892bd1
Volume 14
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