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.

ABSTRACT:

Background

V591 (TMV-083) is a live recombinant measles vector-based vaccine candidate expressing a pre-fusion stabilized SARS-CoV-2 spike protein.

Methods

We performed a randomized, placebo-controlled Phase I trial with an unblinded dose escalation and a double-blind treatment phase at 2 sites in France and Belgium to evaluate the safety and immunogenicity of V591. Ninety healthy SARS-CoV-2 sero-negative adults (18-55 years of age) were randomized into 3 cohorts, each comprising 24 vaccinees and 6 placebo recipients. Participants received two intramuscular injections of a low dose vaccine (1 × 10⁵ median Tissue Culture Infectious Dose [TCID₅₀]), one or two injections of a high dose vaccine (1 × 10⁶ TCID₅₀), or placebo with a 28 da

SUBMITTER: Launay O 

PROVIDER: S-EPMC8761070 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature