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
N1 - Funding Information:
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.
Publisher Copyright:
© 2023
PY - 2023/3/1
Y1 - 2023/3/1
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
UR - http://www.scopus.com/inward/record.url?scp=85152359962&partnerID=8YFLogxK
U2 - 10.1016/j.cmi.2023.03.007
DO - 10.1016/j.cmi.2023.03.007
M3 - Article
C2 - 36921715
AN - SCOPUS:85152359962
SN - 1198-743X
JO - Clinical Microbiology and Infection
JF - Clinical Microbiology and Infection
ER -
