A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.

Summary

This is a Phase 2/3 open-label study to evaluate the safety and immunogenicity of a booster dose of the XBB.1.5 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M™ in previously mRNA COVID-19 vaccinated adult participants ≥18 years of age and baseline SARS CoV-2 seropositive COVID-19 vaccine naïve participants ≥18 years of age.

Timeline

Start

2023-09-07

Primary completion

2023-11-15

Completion

2024-05-20

Publications

• Alves K, Kouassi A, Plested JS, Kalkeri R, Smith K, Kaba M, Nelson J, Zhu M, Cloney-Clark S, Cai Z, Mallory RM, Noriega F; 2019nCoV-313 Study Investigators. Immunogenicity and safety of a monovalent Omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine in previously unvaccinated, SARS-CoV-2 seropositive participants: Primary day-28 analysis of a phase 2/3 open-label study. Vaccine. 2025 May 10;55:127046. doi: 10.1016/j.vaccine.2025.127046. Epub 2025 Apr 2.
• Alves K, Kotloff K, McClelland RS, Kouassi A, Plested JS, Kalkeri R, Zhu M, Cloney-Clark S, Cai Z, Smith K, Kaba M, Nelson J, Hammershaimb EA, Mallory RM, Noriega F; 2019nCoV-313 Study Investigators. Immunogenicity and safety of a monovalent omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose in US adults: interim analysis of a single-arm phase 2/3 study. Lancet Infect Dis. 2025 May;25(5):585-594. doi: 10.1016/S1473-3099(24)00670-4. Epub 2025 Jan 14.

Drugs

Indications