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Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis

The emergence of SARS-CoV-2 variants of concern (VOCs) and variants of interest (VOIs) with decreased susceptibility to neutralization has generated interest in assessments of booster doses and variant-specific vaccines. Clinical trial participants who received a two-dose primary series of the COVID...

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Autores principales: Choi, Angela, Koch, Matthew, Wu, Kai, Chu, Laurence, Ma, LingZhi, Hill, Anna, Nunna, Naveen, Huang, Wenmei, Oestreicher, Judy, Colpitts, Tonya, Bennett, Hamilton, Legault, Holly, Paila, Yamuna, Nestorova, Biliana, Ding, Baoyu, Montefiori, David, Pajon, Rolando, Miller, Jacqueline M., Leav, Brett, Carfi, Andrea, McPhee, Roderick, Edwards, Darin K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group US 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8604720/
https://www.ncbi.nlm.nih.gov/pubmed/34526698
http://dx.doi.org/10.1038/s41591-021-01527-y
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author Choi, Angela
Koch, Matthew
Wu, Kai
Chu, Laurence
Ma, LingZhi
Hill, Anna
Nunna, Naveen
Huang, Wenmei
Oestreicher, Judy
Colpitts, Tonya
Bennett, Hamilton
Legault, Holly
Paila, Yamuna
Nestorova, Biliana
Ding, Baoyu
Montefiori, David
Pajon, Rolando
Miller, Jacqueline M.
Leav, Brett
Carfi, Andrea
McPhee, Roderick
Edwards, Darin K.
author_facet Choi, Angela
Koch, Matthew
Wu, Kai
Chu, Laurence
Ma, LingZhi
Hill, Anna
Nunna, Naveen
Huang, Wenmei
Oestreicher, Judy
Colpitts, Tonya
Bennett, Hamilton
Legault, Holly
Paila, Yamuna
Nestorova, Biliana
Ding, Baoyu
Montefiori, David
Pajon, Rolando
Miller, Jacqueline M.
Leav, Brett
Carfi, Andrea
McPhee, Roderick
Edwards, Darin K.
author_sort Choi, Angela
collection PubMed
description The emergence of SARS-CoV-2 variants of concern (VOCs) and variants of interest (VOIs) with decreased susceptibility to neutralization has generated interest in assessments of booster doses and variant-specific vaccines. Clinical trial participants who received a two-dose primary series of the COVID-19 vaccine mRNA-1273 approximately 6 months earlier entered an open-label phase 2a study (NCT04405076) to evaluate the primary objectives of safety and immunogenicity of a single booster dose of mRNA-1273 or variant-modified mRNAs, including multivalent mRNA-1273.211. As the trial is currently ongoing, this exploratory interim analysis includes preliminary descriptive results only of four booster groups (n = 20 per group). Immediately before the booster dose, neutralizing antibodies against wild-type D614G virus had waned (P < 0.0001) relative to peak titers against wild-type D614G measured 1 month after the primary series, and neutralization titers against B.1.351 (Beta), P.1 (Gamma) and B.1.617.2 (Delta) VOCs were either low or undetectable. Both the mRNA-1273 booster and variant-modified boosters were safe and well-tolerated. All boosters, including mRNA-1273, numerically increased neutralization titers against the wild-type D614G virus compared to peak titers against wild-type D614G measured 1 month after the primary series; significant increases were observed for mRNA-1273 and mRNA-1273.211 (P < 0.0001). In addition, all boosters increased neutralization titers against key VOCs and VOIs, including B.1.351, P.1. and B.1.617.2, that were statistically equivalent to peak titers measured after the primary vaccine series against wild-type D614G virus, with superior titers against some VOIs. This trial is ongoing.
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spelling pubmed-86047202021-12-03 Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis Choi, Angela Koch, Matthew Wu, Kai Chu, Laurence Ma, LingZhi Hill, Anna Nunna, Naveen Huang, Wenmei Oestreicher, Judy Colpitts, Tonya Bennett, Hamilton Legault, Holly Paila, Yamuna Nestorova, Biliana Ding, Baoyu Montefiori, David Pajon, Rolando Miller, Jacqueline M. Leav, Brett Carfi, Andrea McPhee, Roderick Edwards, Darin K. Nat Med Article The emergence of SARS-CoV-2 variants of concern (VOCs) and variants of interest (VOIs) with decreased susceptibility to neutralization has generated interest in assessments of booster doses and variant-specific vaccines. Clinical trial participants who received a two-dose primary series of the COVID-19 vaccine mRNA-1273 approximately 6 months earlier entered an open-label phase 2a study (NCT04405076) to evaluate the primary objectives of safety and immunogenicity of a single booster dose of mRNA-1273 or variant-modified mRNAs, including multivalent mRNA-1273.211. As the trial is currently ongoing, this exploratory interim analysis includes preliminary descriptive results only of four booster groups (n = 20 per group). Immediately before the booster dose, neutralizing antibodies against wild-type D614G virus had waned (P < 0.0001) relative to peak titers against wild-type D614G measured 1 month after the primary series, and neutralization titers against B.1.351 (Beta), P.1 (Gamma) and B.1.617.2 (Delta) VOCs were either low or undetectable. Both the mRNA-1273 booster and variant-modified boosters were safe and well-tolerated. All boosters, including mRNA-1273, numerically increased neutralization titers against the wild-type D614G virus compared to peak titers against wild-type D614G measured 1 month after the primary series; significant increases were observed for mRNA-1273 and mRNA-1273.211 (P < 0.0001). In addition, all boosters increased neutralization titers against key VOCs and VOIs, including B.1.351, P.1. and B.1.617.2, that were statistically equivalent to peak titers measured after the primary vaccine series against wild-type D614G virus, with superior titers against some VOIs. This trial is ongoing. Nature Publishing Group US 2021-09-15 2021 /pmc/articles/PMC8604720/ /pubmed/34526698 http://dx.doi.org/10.1038/s41591-021-01527-y Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Choi, Angela
Koch, Matthew
Wu, Kai
Chu, Laurence
Ma, LingZhi
Hill, Anna
Nunna, Naveen
Huang, Wenmei
Oestreicher, Judy
Colpitts, Tonya
Bennett, Hamilton
Legault, Holly
Paila, Yamuna
Nestorova, Biliana
Ding, Baoyu
Montefiori, David
Pajon, Rolando
Miller, Jacqueline M.
Leav, Brett
Carfi, Andrea
McPhee, Roderick
Edwards, Darin K.
Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis
title Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis
title_full Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis
title_fullStr Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis
title_full_unstemmed Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis
title_short Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis
title_sort safety and immunogenicity of sars-cov-2 variant mrna vaccine boosters in healthy adults: an interim analysis
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8604720/
https://www.ncbi.nlm.nih.gov/pubmed/34526698
http://dx.doi.org/10.1038/s41591-021-01527-y
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