Interim report of the reactogenicity and immunogenicity of SARS-CoV-2 XBB-containing vaccines.

Publication date: Feb 13, 2024

Monovalent Omicron XBB. 1.5-containing vaccines were approved for Coronavirus disease 2019 (COVID-19) 2023-2024 immunizations. This ongoing, open-label, phase 2/3 study evaluated mRNA-1273. 815-monovalent (50-ug Omicron XBB. 1.5-spike mRNA) and mRNA-1273. 231-bivalent (25-ug each Omicron XBB. 1.5- and BA. 4/BA. 5-spike mRNAs))vaccines, administered as 5th doses to adults who previously received a primary series, a 3rd dose of an original mRNA COVID-19 vaccine, and a 4th dose of an Omicron BA. 4/BA. 5 bivalent vaccine. Interim safety and immunogenicity results 29 days post-vaccination are reported. Participants (randomized 1:1) received 50-ug mRNA-1273. 815(n=50) or mRNA-1273. 231(n=51); median (interquartile range) months from the prior BA. 4/BA. 5-bivalent dose were 8. 2 (8. 1-8. 3) and 8. 3 (8. 1-8. 4), respectively. Neutralizing antibody (nAb) increased from pre-booster levels against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants tested. Day 29 nAb fold-increases from pre-booster levels were numerically higher against XBB. 1.5, XBB. 1.16, EG. 5.1, BA. 2.86, and JN. 1 than BA. 4/BA. 5, BQ. 1.1 and D614G. The monovalent vaccine also cross-neutralized FL. 1.5. 1, EG. 5.1, BA. 2.86, HK. 3.1, HV. 1 and JN. 1 variants in a participant (n=20) subset, 15 days post-vaccination. Reactogenicity was similar to previously reported mRNA-1273 original and bivalent vaccines. XBB. 1.5-containing mRNA-1273 vaccines elicit robust, diverse nAb responses against more recent SARS-CoV-2 variants including JN. 1, supporting the XBB. 1.5-spike sequence selection for the 2023-2024 COVID-19 vaccine update.

Concepts Keywords
Coronavirus BA.2.86
D614g COVID-19
Immunizations EG.5.1
Mrnasvaccines HK.3.1
immune response
JN 1
mRNA vaccine
neutralizing antibody
SARS-CoV-2 variants


Type Source Name
disease VO report
disease MESH Coronavirus disease 2019
disease VO dose
disease VO COVID-19 vaccine
disease VO vaccine
disease VO vaccination
disease VO Severe acute respiratory syndrome coronavirus 2
disease IDO immune response

Original Article

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