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Safety and Immunity of Covid-19 aAPC Vaccine

RecruitingPhase 1

Sponsor: Shenzhen Geno-Immune Medical Institute

Conditions: Treat and Prevent Covid-19 Infection

Interventions: Pathogen-specific aAPC

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 6 Months to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Healthy and Covid-19-positive volunteers
* The interval between the onset of symptoms and randomized is within 7 days in Covid-19 patients. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;
* White blood cells ≥ 3,500/μl, lymphocytes ≥ 750/μl;
* Human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or tuberculosis (TB) test negative;
* Sign the Informed Consent voluntarily;

Exclusion Criteria:

* Subject with active HCV, HBV or HIV infection.
* Subject is albumin-intolerant.
* Subject with life expectancy less than 4 weeks.
* Subject participated in other investigational vaccine therapies within the past 60 days.
* Subject with positive pregnancy test result.
* Researchers consider unsuitable.

Locations (1)

Shenzhen, Guangdong, China