Clinical Research Directory
Browse clinical research sites, groups, and studies.
Immunity and Safety of Covid-19 Synthetic Minigene Vaccine
Sponsor: Shenzhen Geno-Immune Medical Institute
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.
Official title: Phase I/II Multicenter Trial of Lentiviral Minigene Vaccine (LV-SMENP) of Covid-19 Coronavirus
Key Details
Gender
All
Age Range
6 Months - 80 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-06-01
Completion Date
2030-12-31
Last Updated
2026-06-23
Healthy Volunteers
No
Conditions
Interventions
Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs
Patients will receive approximately 5x10\^6 LV-DC vaccine and 1x10\^8 CTLs via sub-cutaneous injections and iv infusions, respectively.
Locations (1)
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China