A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants

Summary

This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver solid organ transplant (SOT) and in healthy adult participants. The primary goal of the study is to evaluate the safety of mRNA-1273 and the serum antibody (Ab) responses obtained 28 days after the last dose of mRNA-1273.

Timeline

Start

2021-04-16

Primary completion

2023-05-22

Completion

2023-05-22

Publications

• Girard B, Figueroa AL, De Rosa SC, McElrath MJ, Azzi JR, Stolman D, Siangphoe U, de Windt E, Miller JM, Das R, Priddy F. mRNA-1273 COVID-19 vaccine induces CD4+ T-cell responses among solid organ transplant recipients. Front Immunol. 2025 Apr 3;16:1505871. doi: 10.3389/fimmu.2025.1505871. eCollection 2025.
• Figueroa AL, Azzi JR, Eghtesad B, Priddy F, Stolman D, Siangphoe U, Leony Lasso I, de Windt E, Girard B, Zhou H, Miller JM, Das R. Safety and Immunogenicity of the mRNA-1273 Coronavirus Disease 2019 Vaccine in Solid Organ Transplant Recipients. J Infect Dis. 2024 Sep 23;230(3):e591-e600. doi: 10.1093/infdis/jiae140.

Drugs

Indications