A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants

Summary

This is a study to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529, mRNA-1273.214, mRNA-1273.222, mRNA-1273.815, and mRNA-1273.231 administered as booster doses.

Timeline

Start

2021-05-28

Primary completion

2023-11-17

Completion

2023-11-17

Publications

• Chalkias S, Whatley JL, Eder F, Essink B, Khetan S, Bradley P, Brosz A, McGhee N, Tomassini JE, Chen X, Zhao X, Sutherland A, Shen X, Girard B, Edwards DK, Feng J, Zhou H, Walsh S, Montefiori DC, Baden LR, Miller JM, Das R. Original SARS-CoV-2 monovalent and Omicron BA.4/BA.5 bivalent COVID-19 mRNA vaccines: phase 2/3 trial interim results. Nat Med. 2023 Sep;29(9):2325-2333. doi: 10.1038/s41591-023-02517-y. Epub 2023 Aug 31.
• Chalkias S, Harper C, Vrbicky K, Walsh SR, Essink B, Brosz A, McGhee N, Tomassini JE, Chen X, Chang Y, Sutherland A, Montefiori DC, Girard B, Edwards DK, Feng J, Zhou H, Baden LR, Miller JM, Das R. A Bivalent Omicron-Containing Booster Vaccine against Covid-19. N Engl J Med. 2022 Oct 6;387(14):1279-1291. doi: 10.1056/NEJMoa2208343. Epub 2022 Sep 16.
• Chalkias S, Schwartz H, Nestorova B, Feng J, Chang Y, Zhou H, Dutko FJ, Edwards DK, Montefiori D, Pajon R, Leav B, Miller JM, Das R. Safety and Immunogenicity of a 100 mug mRNA-1273 Vaccine Booster for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). medRxiv [Preprint]. 2022 Mar 7:2022.03.04.22271830. doi: 10.1101/2022.03.04.22271830.

Drugs

Indications