Immunogenicity and safety of DS-5670d, an omicron XBB.1.5-targeting COVID-19 mRNA vaccine: A phase 3, randomized, active-controlled study.

ABSTRACT:

Background

DS-5670d is a monovalent lipid nanoparticle-messenger ribonucleic acid vaccine against severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), containing an omicron XBB.1.5-derived antigen. This phase 3 non-inferiority study assessed the immunogenicity and safety of a single dose of DS-5670d according to participant immune status.

Methods and findings

Participants aged ≥12 years were stratified according to their history of both prior SARS-CoV-2 infection plus prior coronavirus disease 2019 vaccination (subpopulation A), prior infection only (subpopulation B), prior vaccination only (subpopulation C), or no history of either infection or vaccination (subpopulation D), and randomly assigned (1:1) to receive DS-5670d or monovalent BNT162b2 omicron XBB.1.5. The

SUBMITTER: Kawamoto A 

PROVIDER: S-EPMC12517495 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature