A Study to Evaluate the Safety and Immunogenicity of Vaccine CVnCoV in Healthy Adults in Germany for COVID-19

Summary

This study aims to evaluate the safety (in all participants) and reactogenicity (in a subset of participants) of CVnCoV administered as a 2-dose schedule to adult participants 18 years of age or older. The study also aims to assess antibody responses to the receptor-binding domain (RBD) of spike (S) protein of SARS-CoV-2 after 1 and 2 doses of CVnCoV in adults 18 years of age or older included in a subset of participants.

Timeline

Start

2020-12-23

Primary completion

2022-06-08

Completion

2022-06-08

Publications

• Kowalzik F, Teschner D, Mesquita M, Jensen C, Schreiner D, Kronfeld K, Tubic-Grozdanis M, Cheatham-Seitz D, Hettich F, Quintini G, Schoenborn-Kellenberger O, Codo P, von Eisenhart-Rothe P, Mann P, Oostvogels L, Gehring S. A phase 3, randomised, observer-blinded, placebo controlled-trial evaluating the safety and immunogenicity of investigational SARS-CoV-2 mRNA vaccine CVnCoV in adult healthcare workers in Mainz (Germany). Vaccine X. 2024 Jun 20;19:100512. doi: 10.1016/j.jvacx.2024.100512. eCollection 2024 Aug.

Drugs

Indications