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LB750. Safety and Immunogenicity of a Bivalent Omicron-Containing Booster Vaccine against COVID-19

BACKGROUND: Vaccination strategies that provide enhanced immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants are needed. We evaluated the safety and immunogenicity of a bivalent omicron containing vaccine, mRNA-1273.214 (50 µg), administered as a second booster dos...

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Autores principales: Chalkias, Spyros, Harper, Charles, Vrbicky, Keith, Walsh, Stephen R, Essink, Brandon, Brosz, Adam, McGhee, Nichole, Tomassini, Joanne, Chen, Xing, Chang, Ying, Sutherland, Andrea, Montefiori, David, Girard, Bethany, Edwards, Darin, Feng, Jing, Zhou, Honghong, Baden, Lindsey R, Miller, Jacqueline, Das, Rituparna
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9752807/
http://dx.doi.org/10.1093/ofid/ofac492.1873
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author Chalkias, Spyros
Harper, Charles
Vrbicky, Keith
Walsh, Stephen R
Essink, Brandon
Brosz, Adam
McGhee, Nichole
Tomassini, Joanne
Chen, Xing
Chang, Ying
Sutherland, Andrea
Montefiori, David
Girard, Bethany
Edwards, Darin
Feng, Jing
Zhou, Honghong
Baden, Lindsey R
Miller, Jacqueline
Das, Rituparna
author_facet Chalkias, Spyros
Harper, Charles
Vrbicky, Keith
Walsh, Stephen R
Essink, Brandon
Brosz, Adam
McGhee, Nichole
Tomassini, Joanne
Chen, Xing
Chang, Ying
Sutherland, Andrea
Montefiori, David
Girard, Bethany
Edwards, Darin
Feng, Jing
Zhou, Honghong
Baden, Lindsey R
Miller, Jacqueline
Das, Rituparna
author_sort Chalkias, Spyros
collection PubMed
description BACKGROUND: Vaccination strategies that provide enhanced immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants are needed. We evaluated the safety and immunogenicity of a bivalent omicron containing vaccine, mRNA-1273.214 (50 µg), administered as a second booster dose in adult participants. METHODS: In this ongoing phase 2/3 trial, 50 µg of the bivalent vaccine mRNA-1273.214 (25 µg each ancestral Wuhan-Hu-1 and omicron BA.1 spike mRNAs) or 50 µg of the authorized mRNA-1273 were administered as second boosters in adults who previously received a 2 dose (100 µg) primary series and a first booster (50 µg) dose of mRNA-1273 (≥ 3 months prior). Primary objectives were safety and reactogenicity and immunogenicity 28 days post-booster dose. RESULTS: In participants with no prior SARS-CoV-2 infection who received booster doses of mRNA-1273.214 (n=334) or mRNA-1273 (n=260), neutralizing antibody (nAb) geometric mean titers (GMTs [95% confidence interval (CI)]) against omicron BA.1 were 2372.4 (2070.6−2718.2) and 1473.5 (1270.8−1708.4), respectively. The model-based GMT ratio (GMR [97.5% CI]) of mRNA-1273.214 compared to mRNA-1273 was 1.75 (1.49−2.04), meeting the pre-specified superiority criterion against omicron BA.1. The pre-specified criterion for non-inferiority against the ancestral SARS-CoV-2 strain was also met. Additionally, mRNA-1273.214 elicited higher GMTs (727.4 [632.8−836.1]) than mRNA-1273 (492.1 [431.1−561.9]) against omicron subvariants BA.4/BA.5 [GMR (95% CI) 1.69 [1.51−1.90])]. Binding antibody responses against alpha, beta, gamma, delta, and omicron were numerically higher in the mRNA-1273.214 group compared to mRNA-1273. mRNA-1273.214 GMTs were consistently higher across age (18-< 65 and ≥ 65 years) and pre-booster SARS-CoV-2 infection subgroups (Figure). Safety and reactogenicity were similar for both vaccine groups. [Figure: see text] CONCLUSION: The bivalent omicron containing mRNA-1273.214 elicited superior nAb responses against omicron 28 days post-immunization compared to mRNA-1273 regardless of age and prior SARS-CoV-2 infection; no new safety concerns were identified. DISCLOSURES: Spyros Chalkias, MD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Stephen R. Walsh, MD, Janssen Vaccines: Grant/Research Support|Moderna, Inc.: Grant/Research Support|NIAID/NIH: Grant/Research Support|Sanofi Pasteur: Grant/Research Support Nichole McGhee, B.S., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Joanne Tomassini, Ph.D., Moderna, Inc.: Advisor/Consultant Xing Chen, Sc.D., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Ying Chang, M.S., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Andrea Sutherland, M.D., MPH, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds David Montefiori, Ph.D., Moderna, Inc.: Grant/Research Support Bethany Girard, Ph.D., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Darin Edwards, Ph.D., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Jing Feng, M.S., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Honghong Zhou, Ph.D., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Lindsey R. Baden, MD, Moderna, Inc.: Grant/Research Support|NIAID: Grant/Research Support Jacqueline Miller, MD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Rituparna Das, M.D., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds.
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spelling pubmed-97528072022-12-16 LB750. Safety and Immunogenicity of a Bivalent Omicron-Containing Booster Vaccine against COVID-19 Chalkias, Spyros Harper, Charles Vrbicky, Keith Walsh, Stephen R Essink, Brandon Brosz, Adam McGhee, Nichole Tomassini, Joanne Chen, Xing Chang, Ying Sutherland, Andrea Montefiori, David Girard, Bethany Edwards, Darin Feng, Jing Zhou, Honghong Baden, Lindsey R Miller, Jacqueline Das, Rituparna Open Forum Infect Dis Abstracts BACKGROUND: Vaccination strategies that provide enhanced immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants are needed. We evaluated the safety and immunogenicity of a bivalent omicron containing vaccine, mRNA-1273.214 (50 µg), administered as a second booster dose in adult participants. METHODS: In this ongoing phase 2/3 trial, 50 µg of the bivalent vaccine mRNA-1273.214 (25 µg each ancestral Wuhan-Hu-1 and omicron BA.1 spike mRNAs) or 50 µg of the authorized mRNA-1273 were administered as second boosters in adults who previously received a 2 dose (100 µg) primary series and a first booster (50 µg) dose of mRNA-1273 (≥ 3 months prior). Primary objectives were safety and reactogenicity and immunogenicity 28 days post-booster dose. RESULTS: In participants with no prior SARS-CoV-2 infection who received booster doses of mRNA-1273.214 (n=334) or mRNA-1273 (n=260), neutralizing antibody (nAb) geometric mean titers (GMTs [95% confidence interval (CI)]) against omicron BA.1 were 2372.4 (2070.6−2718.2) and 1473.5 (1270.8−1708.4), respectively. The model-based GMT ratio (GMR [97.5% CI]) of mRNA-1273.214 compared to mRNA-1273 was 1.75 (1.49−2.04), meeting the pre-specified superiority criterion against omicron BA.1. The pre-specified criterion for non-inferiority against the ancestral SARS-CoV-2 strain was also met. Additionally, mRNA-1273.214 elicited higher GMTs (727.4 [632.8−836.1]) than mRNA-1273 (492.1 [431.1−561.9]) against omicron subvariants BA.4/BA.5 [GMR (95% CI) 1.69 [1.51−1.90])]. Binding antibody responses against alpha, beta, gamma, delta, and omicron were numerically higher in the mRNA-1273.214 group compared to mRNA-1273. mRNA-1273.214 GMTs were consistently higher across age (18-< 65 and ≥ 65 years) and pre-booster SARS-CoV-2 infection subgroups (Figure). Safety and reactogenicity were similar for both vaccine groups. [Figure: see text] CONCLUSION: The bivalent omicron containing mRNA-1273.214 elicited superior nAb responses against omicron 28 days post-immunization compared to mRNA-1273 regardless of age and prior SARS-CoV-2 infection; no new safety concerns were identified. DISCLOSURES: Spyros Chalkias, MD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Stephen R. Walsh, MD, Janssen Vaccines: Grant/Research Support|Moderna, Inc.: Grant/Research Support|NIAID/NIH: Grant/Research Support|Sanofi Pasteur: Grant/Research Support Nichole McGhee, B.S., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Joanne Tomassini, Ph.D., Moderna, Inc.: Advisor/Consultant Xing Chen, Sc.D., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Ying Chang, M.S., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Andrea Sutherland, M.D., MPH, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds David Montefiori, Ph.D., Moderna, Inc.: Grant/Research Support Bethany Girard, Ph.D., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Darin Edwards, Ph.D., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Jing Feng, M.S., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Honghong Zhou, Ph.D., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Lindsey R. Baden, MD, Moderna, Inc.: Grant/Research Support|NIAID: Grant/Research Support Jacqueline Miller, MD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Rituparna Das, M.D., Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds. Oxford University Press 2022-12-15 /pmc/articles/PMC9752807/ http://dx.doi.org/10.1093/ofid/ofac492.1873 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Abstracts
Chalkias, Spyros
Harper, Charles
Vrbicky, Keith
Walsh, Stephen R
Essink, Brandon
Brosz, Adam
McGhee, Nichole
Tomassini, Joanne
Chen, Xing
Chang, Ying
Sutherland, Andrea
Montefiori, David
Girard, Bethany
Edwards, Darin
Feng, Jing
Zhou, Honghong
Baden, Lindsey R
Miller, Jacqueline
Das, Rituparna
LB750. Safety and Immunogenicity of a Bivalent Omicron-Containing Booster Vaccine against COVID-19
title LB750. Safety and Immunogenicity of a Bivalent Omicron-Containing Booster Vaccine against COVID-19
title_full LB750. Safety and Immunogenicity of a Bivalent Omicron-Containing Booster Vaccine against COVID-19
title_fullStr LB750. Safety and Immunogenicity of a Bivalent Omicron-Containing Booster Vaccine against COVID-19
title_full_unstemmed LB750. Safety and Immunogenicity of a Bivalent Omicron-Containing Booster Vaccine against COVID-19
title_short LB750. Safety and Immunogenicity of a Bivalent Omicron-Containing Booster Vaccine against COVID-19
title_sort lb750. safety and immunogenicity of a bivalent omicron-containing booster vaccine against covid-19
topic Abstracts
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9752807/
http://dx.doi.org/10.1093/ofid/ofac492.1873
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