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RECRUITING
NCT04299724
PHASE1

Safety and Immunity of Covid-19 aAPC Vaccine

Sponsor: Shenzhen Geno-Immune Medical Institute

View on ClinicalTrials.gov

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.

Official title: Safety and Immunity Evaluation of A Covid-19 Coronavirus Artificial Antigen Presenting Cell Vaccine

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

Interventions

BIOLOGICAL

Pathogen-specific aAPC

The subjects will receive three injections of 5x10\^6 each Covid-19/aAPC vaccine via subcutaneous injections.

Locations (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China