Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine

Summary

This is a randomized, placebo-controlled, two center, Phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and a double blind treatment phase to investigate the safety, tolerability and immunogenicity of a novel measles-vector based vaccine candidate against SARS-CoV-2 infection (TMV-083/V-591).

Timeline

Start

2020-08-10

Primary completion

2021-05-12

Completion

2021-05-12

Outcome

Missed primary endpoint

release “In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection” merck.com ↗

Publications

• Results Launay O, Artaud C, Lachatre M, Ait-Ahmed M, Klein J, Luong Nguyen LB, Durier C, Jansen B, Tomberger Y, Jolly N, Grossmann A, Tabbal H, Brunet J, Gransagne M, Choucha Z, Batalie D, Delgado A, Mullner M, Tschismarov R, Berghmans PJ, Martin A, Ramsauer K, Escriou N, Gerke C. Safety and immunogenicity of a measles-vectored SARS-CoV-2 vaccine candidate, V591 / TMV-083, in healthy adults: results of a randomized, placebo-controlled Phase I study. EBioMedicine. 2022 Jan;75:103810. doi: 10.1016/j.ebiom.2021.103810. Epub 2022 Jan 16.

Drugs

Indications