Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old

Summary

Prevention of COVID-19 caused by SARS-CoV-2.

Timeline

Start

2022-08-12

Primary completion

2023-08-18

Completion

2023-08-18

Publications

• Background Essink BJ, Shapiro C, Isidro MGD, Bradley P, Pragalos A, Bloch M, Santiaguel J, Frias MV, Miyakis S, Alves de Mesquita M, Berre S, Servais C, Waugh N, Hoffmann C, Baba E, Schonborn-Kellenberger O, Wolz OO, Koch SD, Ganyani T, Boutet P, Mann P, Mueller SO, Ramanathan R, Gaudinski MR, Vanhoutte N. Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study. Hum Vaccin Immunother. 2024 Dec 31;20(1):2408863. doi: 10.1080/21645515.2024.2408863. Epub 2024 Oct 18.
• Roth N, Gergen J, Kovacikova K, Mueller SO, Ulrich L, Schon J, Halwe NJ, Fricke C, Corleis B, Dorhoi A, Hoffmann D, Beer M, Maione D, Petsch B, Rauch S. Assessment of Immunogenicity and Efficacy of CV0501 mRNA-Based Omicron COVID-19 Vaccination in Small Animal Models. Vaccines (Basel). 2023 Jan 31;11(2):318. doi: 10.3390/vaccines11020318.

Drugs

Indications