At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Multicenter Trial of Lentiviral Minigene Vaccine (LV-SMENP) of Covid-19 Coronavirus
In Brief
A Phase 1 clinical trial evaluating Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs for Pathogen Infection Covid-19 Infection. Currently recruiting, targeting 100 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Patients will receive approximately 5x10\^6 LV-DC vaccine and 1x10\^8 CTLs via sub-cutaneous injections and iv infusions, respectively.
Interventions
Patients will receive approximately 5x10\^6 LV-DC vaccine and 1x10\^8 CTLs via sub-cutaneous injections and iv infusions, respectively.