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Immunity and Safety of Covid-19 Synthetic Minigene Vaccine

NCT04276896 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-03-19

No results posted yet for this study

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.

Conditions

  • Pathogen Infection Covid-19 Infection

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • Shenzhen Third People's Hospital

    collaborator OTHER

  • Shenzhen Second People's Hospital

    collaborator OTHER

  • Shenzhen Geno-Immune Medical Institute

    lead OTHER

Principal Investigators

  • Lung-Ji Chang, PhD · Shenzhen Geno-Immune Medical Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-24
Primary Completion
2023-07-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04276896 on ClinicalTrials.gov