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NCT04276896
Immunity and Safety of Covid-19 Synthetic Minigene Vaccine
Phase 1, PHASE2 trial testing Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs in Pathogen Infection Covid-19 Infection in 100 participants. Status unknown.
31 July 2023
Quick facts
| Lead sponsor | Shenzhen Geno-Immune Medical Institute |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 24 March 2020 |
| Primary completion | 31 July 2023 |
| Estimated completion | 31 December 2024 |
| Sites | 3 locations across China |
Drugs / interventions tested
- Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs — full drug profile →
Conditions studied
- Pathogen Infection Covid-19 Infection — all drugs for Pathogen Infection Covid-19 Infection →
Sponsor
Shenzhen Geno-Immune Medical Institute
Who can join
Adults 6 Months to 80, any sex, with Pathogen Infection Covid-19 Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04276896
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04276896 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shenzhen Geno-Immune Medical Institute
- Last refreshed: 19 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04276896.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing