NCT04299724 Safety and Immunity of Covid-19 aAPC Vaccine
| NCT ID | NCT04299724 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shenzhen Geno-Immune Medical Institute |
| Condition | Treat and Prevent Covid-19 Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2026-06-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Lung-Ji Chang
PRINCIPAL INVESTIGATOR
Shenzhen Geno-Immune Medical Institute
Frequently Asked Questions
Who can join the NCT04299724 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 80 Years, studying Treat and Prevent Covid-19 Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04299724 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04299724 currently recruiting?
Yes, NCT04299724 is actively recruiting participants. Contact the research team at c@szgimi.org for enrollment information.
Where is the NCT04299724 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT04299724 clinical trial?
NCT04299724 is sponsored by Shenzhen Geno-Immune Medical Institute. The principal investigator is Lung-Ji Chang at Shenzhen Geno-Immune Medical Institute. The trial plans to enroll 100 participants.
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