drugset / Trial / NCT04276896

Immunity and Safety of Covid-19 Synthetic Minigene Vaccine

NCT04276896 ↗

Phase 1/2 Recruiting 100 enrolled Shenzhen Geno-Immune Medical Institute
NaSingle-groupOpen-labelTreatment

Summary

In December 2019, viral pneumonia caused by a novel beta-coronavirus (Covid-19) broke out in Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratory failure and died, making it imperative to develop a safe and effective vaccine to treat and prevent severe Covid-19 pneumonia. Based on detailed analysis of the viral genome and search for potential immunogenic targets, a synthetic minigene has been engineered based on conserved domains of the viral structural proteins and a polyprotein protease. The infection of Covid-19 is mediated through binding of the Spike protein to the ACEII receptor, and the viral replication depends on molecular mechanisms of all of these viral proteins. This trial proposes to develop and test innovative Covid-19 minigenes engineered based on multiple viral genes, using an efficient lentiviral vector system (NHP/TYF) to express viral proteins and immune modulatory genes to modify dendritic cells (DCs) and to activate T cells. In this study, the safety and efficacy of this LV vaccine (LV-SMENP) will be investigated.

Timeline

Start
2026-06-01
Primary completion
2029-12-31
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject LV-SMENP-DC vaccine Cell therapy 5e+06 cells Subcutaneous
Subject antigen-specific CTLs Cell therapy 1e+08 cells Intravenous

Indications