drugset / Trial / NCT04299724

Safety and Immunity of Covid-19 aAPC Vaccine

NCT04299724 ↗

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

Summary

In December 2019, viral pneumonia (Covid-19) caused by a novel beta-coronavirus (SARS-CoV-2) 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 universal vaccine 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 artificial antigen presenting cells (aAPC) and to activate T cells. In this study, the safety and immune reactivity of this aAPC vaccine will be investigated.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Pathogen-specific aAPC Cell therapy 5e+06 cells Subcutaneous

Indications

No indication recorded.