Immunogenicity of Omicron BA.1-adapted BNT162b2 vaccines: randomized trial, 3-month follow-up

Noam Barda; Yaniv Lustig; Victoria Indenbaum; Daniel Zibly; Gili Joseph; Keren Asraf; Yael Weiss-Ottolenghi; Sharon Amit; Limor Kliker; Bayan Abd Elkader; Eytan Ben-Ami; Michal Canetti; Ravit Koren; Shiri Katz-Likvornik; Osnat Halpern; Ella Mendelson; Ram Doolman; Dror Harats; Yitshak Kreiss; Michal Mandelboim; Gili Regev-Yochay

doi:10.1016/j.cmi.2023.03.007

Immunogenicity of Omicron BA.1-adapted BNT162b2 vaccines: randomized trial, 3-month follow-up

Noam Barda, Yaniv Lustig, Victoria Indenbaum, Daniel Zibly, Gili Joseph, Keren Asraf, Yael Weiss-Ottolenghi, Sharon Amit, Limor Kliker, Bayan Abd Elkader, Eytan Ben-Ami, Michal Canetti, Ravit Koren, Shiri Katz-Likvornik, Osnat Halpern, Ella Mendelson, Ram Doolman, Dror Harats, Yitshak Kreiss, Michal MandelboimGili Regev-Yochay

Research output: Contribution to journal › Article › peer-review

10 Scopus citations

Abstract

Objectives: The capability of the SARS-CoV-2 Omicron variant to escape immunity conferred by mRNA vaccines has led to the development of Omicron-adapted vaccines. In this study, we aimed to compare the immune response with the ancestral strain and with the BA.1 Omicron variant after administration of the original vaccine and the Omicron-adapted vaccine. Methods: This is an ongoing phase 3, double-blinded randomized controlled trial, comparing the original BNT161b2 vaccine, monovalent Omicron BA.1-adapted BNT161b2 vaccine, and bivalent combinations. Each vaccine was given at a 30 μg and 60 μg dose. Primary outcomes considered included neutralization titers of SARS-CoV-2 ancestral strain and Omicron BA.1. Exploratory endpoints included neutralization titers for Omicron BA.5, and the incidence of COVID-19 cases. Results: Overall, 122 individuals (22, 19, 20, 20, 20, 20, and 21 in each arm) completed a 90-day follow-up. Three months after vaccination, adjusting for baseline levels, neutralizing antibody titers were 0.63 (95% CI: 0.3–1.32) and 0.54 (0.24–1.2) for monovalent/60 μg, 0.9 (0.42–1.92) and 2.69 (1.17–6.17) times for monovalent-Omi.BA.1/30 μg, 1.28 (0.6–2.75) and 2.79 (1.21–6.41) times for monovalent-Omi.BA.1/60 μg, 0.96 (0.46–1.97) and 2.07 (0.93–4.58) times for bivalent-Omi.BA.1/30 μg, and 0.79 (0.38–1.63) and 1.95 (0.88–4.32) times for bivalent-Omi.BA.1/60 μg when compared with BNT162b2/30 μg against the ancestral strain and BA.1 variant, respectively. Discussion: : BA.1-adapted mRNA vaccines lead to a stronger neutralizing antibody response against the Omicron BA.1 sub-variant.

Original language	English
Pages (from-to)	918-923
Number of pages	6
Journal	Clinical Microbiology and Infection
Volume	29
Issue number	7
Early online date	13 Mar 2023
DOIs	https://doi.org/10.1016/j.cmi.2023.03.007
State	Published - Jul 2023
Externally published	Yes

Bibliographical note

Publisher Copyright:
© 2023

Funding

GR-Y served as a member of an Advisory Board of Moderna and MSD; received consulting fees from Medison; and speaking fees from Teva, MSD , Pfizer , Astrazeneca, and Medison. YL received a grant from Pfizer outside the submitted work. All other authors declare of no conflict of interest.

Funders	Funder number
Pfizer

Keywords

COVID-19
Immunogenicity
Omicron
Vaccine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.cmi.2023.03.007

Cite this

Barda, N., Lustig, Y., Indenbaum, V., Zibly, D., Joseph, G., Asraf, K., Weiss-Ottolenghi, Y., Amit, S., Kliker, L., Abd Elkader, B., Ben-Ami, E., Canetti, M., Koren, R., Katz-Likvornik, S., Halpern, O., Mendelson, E., Doolman, R., Harats, D., Kreiss, Y., ... Regev-Yochay, G. (2023). Immunogenicity of Omicron BA.1-adapted BNT162b2 vaccines: randomized trial, 3-month follow-up. Clinical Microbiology and Infection, 29(7), 918-923. https://doi.org/10.1016/j.cmi.2023.03.007

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title = "Immunogenicity of Omicron BA.1-adapted BNT162b2 vaccines: randomized trial, 3-month follow-up",

abstract = "Objectives: The capability of the SARS-CoV-2 Omicron variant to escape immunity conferred by mRNA vaccines has led to the development of Omicron-adapted vaccines. In this study, we aimed to compare the immune response with the ancestral strain and with the BA.1 Omicron variant after administration of the original vaccine and the Omicron-adapted vaccine. Methods: This is an ongoing phase 3, double-blinded randomized controlled trial, comparing the original BNT161b2 vaccine, monovalent Omicron BA.1-adapted BNT161b2 vaccine, and bivalent combinations. Each vaccine was given at a 30 μg and 60 μg dose. Primary outcomes considered included neutralization titers of SARS-CoV-2 ancestral strain and Omicron BA.1. Exploratory endpoints included neutralization titers for Omicron BA.5, and the incidence of COVID-19 cases. Results: Overall, 122 individuals (22, 19, 20, 20, 20, 20, and 21 in each arm) completed a 90-day follow-up. Three months after vaccination, adjusting for baseline levels, neutralizing antibody titers were 0.63 (95% CI: 0.3–1.32) and 0.54 (0.24–1.2) for monovalent/60 μg, 0.9 (0.42–1.92) and 2.69 (1.17–6.17) times for monovalent-Omi.BA.1/30 μg, 1.28 (0.6–2.75) and 2.79 (1.21–6.41) times for monovalent-Omi.BA.1/60 μg, 0.96 (0.46–1.97) and 2.07 (0.93–4.58) times for bivalent-Omi.BA.1/30 μg, and 0.79 (0.38–1.63) and 1.95 (0.88–4.32) times for bivalent-Omi.BA.1/60 μg when compared with BNT162b2/30 μg against the ancestral strain and BA.1 variant, respectively. Discussion: : BA.1-adapted mRNA vaccines lead to a stronger neutralizing antibody response against the Omicron BA.1 sub-variant.",

keywords = "COVID-19, Immunogenicity, Omicron, Vaccine",

author = "Noam Barda and Yaniv Lustig and Victoria Indenbaum and Daniel Zibly and Gili Joseph and Keren Asraf and Yael Weiss-Ottolenghi and Sharon Amit and Limor Kliker and {Abd Elkader}, Bayan and Eytan Ben-Ami and Michal Canetti and Ravit Koren and Shiri Katz-Likvornik and Osnat Halpern and Ella Mendelson and Ram Doolman and Dror Harats and Yitshak Kreiss and Michal Mandelboim and Gili Regev-Yochay",

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year = "2023",

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doi = "10.1016/j.cmi.2023.03.007",

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volume = "29",

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Barda, N, Lustig, Y, Indenbaum, V, Zibly, D, Joseph, G, Asraf, K, Weiss-Ottolenghi, Y, Amit, S, Kliker, L, Abd Elkader, B, Ben-Ami, E, Canetti, M, Koren, R, Katz-Likvornik, S, Halpern, O, Mendelson, E, Doolman, R, Harats, D, Kreiss, Y, Mandelboim, M & Regev-Yochay, G 2023, 'Immunogenicity of Omicron BA.1-adapted BNT162b2 vaccines: randomized trial, 3-month follow-up', Clinical Microbiology and Infection, vol. 29, no. 7, pp. 918-923. https://doi.org/10.1016/j.cmi.2023.03.007

TY - JOUR

T1 - Immunogenicity of Omicron BA.1-adapted BNT162b2 vaccines

T2 - randomized trial, 3-month follow-up

AU - Barda, Noam

AU - Lustig, Yaniv

AU - Indenbaum, Victoria

AU - Zibly, Daniel

AU - Joseph, Gili

AU - Asraf, Keren

AU - Weiss-Ottolenghi, Yael

AU - Amit, Sharon

AU - Kliker, Limor

AU - Abd Elkader, Bayan

AU - Ben-Ami, Eytan

AU - Canetti, Michal

AU - Koren, Ravit

AU - Katz-Likvornik, Shiri

AU - Halpern, Osnat

AU - Mendelson, Ella

AU - Doolman, Ram

AU - Harats, Dror

AU - Kreiss, Yitshak

AU - Mandelboim, Michal

AU - Regev-Yochay, Gili

PY - 2023/7

Y1 - 2023/7

N2 - Objectives: The capability of the SARS-CoV-2 Omicron variant to escape immunity conferred by mRNA vaccines has led to the development of Omicron-adapted vaccines. In this study, we aimed to compare the immune response with the ancestral strain and with the BA.1 Omicron variant after administration of the original vaccine and the Omicron-adapted vaccine. Methods: This is an ongoing phase 3, double-blinded randomized controlled trial, comparing the original BNT161b2 vaccine, monovalent Omicron BA.1-adapted BNT161b2 vaccine, and bivalent combinations. Each vaccine was given at a 30 μg and 60 μg dose. Primary outcomes considered included neutralization titers of SARS-CoV-2 ancestral strain and Omicron BA.1. Exploratory endpoints included neutralization titers for Omicron BA.5, and the incidence of COVID-19 cases. Results: Overall, 122 individuals (22, 19, 20, 20, 20, 20, and 21 in each arm) completed a 90-day follow-up. Three months after vaccination, adjusting for baseline levels, neutralizing antibody titers were 0.63 (95% CI: 0.3–1.32) and 0.54 (0.24–1.2) for monovalent/60 μg, 0.9 (0.42–1.92) and 2.69 (1.17–6.17) times for monovalent-Omi.BA.1/30 μg, 1.28 (0.6–2.75) and 2.79 (1.21–6.41) times for monovalent-Omi.BA.1/60 μg, 0.96 (0.46–1.97) and 2.07 (0.93–4.58) times for bivalent-Omi.BA.1/30 μg, and 0.79 (0.38–1.63) and 1.95 (0.88–4.32) times for bivalent-Omi.BA.1/60 μg when compared with BNT162b2/30 μg against the ancestral strain and BA.1 variant, respectively. Discussion: : BA.1-adapted mRNA vaccines lead to a stronger neutralizing antibody response against the Omicron BA.1 sub-variant.

AB - Objectives: The capability of the SARS-CoV-2 Omicron variant to escape immunity conferred by mRNA vaccines has led to the development of Omicron-adapted vaccines. In this study, we aimed to compare the immune response with the ancestral strain and with the BA.1 Omicron variant after administration of the original vaccine and the Omicron-adapted vaccine. Methods: This is an ongoing phase 3, double-blinded randomized controlled trial, comparing the original BNT161b2 vaccine, monovalent Omicron BA.1-adapted BNT161b2 vaccine, and bivalent combinations. Each vaccine was given at a 30 μg and 60 μg dose. Primary outcomes considered included neutralization titers of SARS-CoV-2 ancestral strain and Omicron BA.1. Exploratory endpoints included neutralization titers for Omicron BA.5, and the incidence of COVID-19 cases. Results: Overall, 122 individuals (22, 19, 20, 20, 20, 20, and 21 in each arm) completed a 90-day follow-up. Three months after vaccination, adjusting for baseline levels, neutralizing antibody titers were 0.63 (95% CI: 0.3–1.32) and 0.54 (0.24–1.2) for monovalent/60 μg, 0.9 (0.42–1.92) and 2.69 (1.17–6.17) times for monovalent-Omi.BA.1/30 μg, 1.28 (0.6–2.75) and 2.79 (1.21–6.41) times for monovalent-Omi.BA.1/60 μg, 0.96 (0.46–1.97) and 2.07 (0.93–4.58) times for bivalent-Omi.BA.1/30 μg, and 0.79 (0.38–1.63) and 1.95 (0.88–4.32) times for bivalent-Omi.BA.1/60 μg when compared with BNT162b2/30 μg against the ancestral strain and BA.1 variant, respectively. Discussion: : BA.1-adapted mRNA vaccines lead to a stronger neutralizing antibody response against the Omicron BA.1 sub-variant.

KW - COVID-19

KW - Immunogenicity

KW - Omicron

KW - Vaccine

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Immunogenicity of Omicron BA.1-adapted BNT162b2 vaccines: randomized trial, 3-month follow-up

Abstract

Bibliographical note

Funding

Keywords

UN SDGs

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