A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters

Summary

The main goal of Part A of this study is to assess the safety, reactogenicity, and immunogenicity of the study vaccine candidates. The main goal of Part B of this study is to assess the safety, reactogenicity, and immunogenicity of the mRNA-1283.529 booster vaccine candidate.

Timeline

Start

2021-12-06

Primary completion

2023-03-23

Completion

2023-03-23

Publications

• Chalkias S, Pragalos A, Akinsola A, Berman G, Ampajwala M, Meyer J, Schoch L, Zhou W, Paila YD, Deng W, Feng J, de Windt E, Edwards D, Miller J, Das R. Safety and Immunogenicity of SARS-CoV-2 Spike Receptor-Binding Domain and N-Terminal Domain mRNA Vaccine. J Infect Dis. 2025 Apr 15;231(4):e754-e763. doi: 10.1093/infdis/jiaf022.
• Stewart-Jones GBE, Elbashir SM, Wu K, Lee D, Renzi I, Ying B, Koch M, Sein CE, Choi A, Whitener B, Garcia-Dominguez D, Henry C, Woods A, Ma L, Montes Berrueta D, Avena LE, Quinones J, Falcone S, Hsiao CJ, Scheaffer SM, Thackray LB, White P, Diamond MS, Edwards DK, Carfi A. Domain-based mRNA vaccines encoding spike protein N-terminal and receptor binding domains confer protection against SARS-CoV-2. Sci Transl Med. 2023 Sep 13;15(713):eadf4100. doi: 10.1126/scitranslmed.adf4100. Epub 2023 Sep 13.
• Stewart-Jones GBE, Elbashir SM, Wu K, Lee D, Renzi I, Ying B, Koch M, Sein CE, Choi A, Whitener B, Garcia-Dominguez D, Henry C, Woods A, Ma L, Montes Berrueta D, Avena LE, Quinones J, Falcone S, Hsiao CJ, Scheaffer SM, Thackray LB, White P, Diamond MS, Edwards DK, Carfi A. Development of SARS-CoV-2 mRNA vaccines encoding spike N-terminal and receptor binding domains. bioRxiv [Preprint]. 2022 Oct 7:2022.10.07.511319. doi: 10.1101/2022.10.07.511319.

Drugs

Indications