drugset / Trial / NCT04990466

Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine.

NCT04990466 ↗

Phase 2/3 Withdrawn NeuroRx, Inc.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

IIBR-100 (VSV-ΔG) is a self-propagating live virus vaccine that contains the spike protein of the Wuhan wild-type SARS-CoV-2 virus. Preclinical and phase 1/2 trials have demonstrated no safety signals of concern and have further demonstrated immunologic response that approximates the response seen in convalescent individuals. The purpose of this phase 2b/3 trial is to document the non-inferiority of IIBR-100 vs. an already-approved vaccine for COVID-19.

Timeline

Start
2021-09-30
Primary completion
2021-12-31
Completion
2022-02-28

Outcome

Outcome not reported

Stopped: “Production of the BriLife vaccine was halted by government sponsor”

Drugs

EvaluationDrugModalityDoseRoute
Subject IIBR-100 Vaccine 1 ml Intramuscular

Indications