Pathogen Infection Covid-19 Infection Clinical Trial
Official title:
Phase I/II Multicenter Trial of Lentiviral Minigene Vaccine (LV-SMENP) of Covid-19 Coronavirus
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | July 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Months to 80 Years |
| Eligibility |
Inclusion Criteria: - Laboratory (RT-PCR) confirmed Covid-19 infection in throat swab and/or sputum and/or lower respiratory tract samples; - The interval between the onset of symptoms and randomized is within 7 days. 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 is negative; - Sign the Informed Consent Form on a voluntary basis; Exclusion Criteria: - Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), or HTLV (HTLV antibody positive). - Subject is albumin-intolerant. - Subject with life expectancy less than 4 weeks. - Subject participated in other investigational somatic cell therapies within past 30 days. - Subject with positive pregnancy test result. - Researchers consider unsuitable. |
| Country | Name | City | State |
|---|---|---|---|
| China | Shenzhen Geno-immune Medical Institute | Shenzhen | Guangdong |
| China | Shenzhen Second People's Hospital | Shenzhen | Guangdong |
| China | Shenzhen Third People's Hospital | Shenzhen | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Shenzhen Geno-Immune Medical Institute | Shenzhen Second People's Hospital, Shenzhen Third People's Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical improvement based on the 7-point scale | A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death). | 28 days after randomization | |
| Primary | Lower Murray lung injury score | Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition. | 7 days after randomization | |
| Secondary | 28-day mortality | Number of deaths during study follow-up | Measured from Day 0 through Day 28 | |
| Secondary | Duration of mechanical ventilation | Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up. | Measured from Day 0 through Day 28 | |
| Secondary | Duration of hospitalization | Days that a participant spent at the hospital. Multiple hospitalizations are summed up. | Measured from Day 0 through Day 28 | |
| Secondary | Proportion of patients with negative RT-PCR results | Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples. | 7 and 14 days after randomization | |
| Secondary | Proportion of patients in each category of the 7-point scale | Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death). | 7,14 and 28 days after randomization | |
| Secondary | Proportion of patients with normalized inflammation factors | Proportion of patients with different inflammation factors in normalization range. | 7 and 14 days after randomization | |
| Secondary | Frequency of vaccine/CTL Events | Frequency of vaccine/CTL Events | Measured from Day 0 through Day 28 | |
| Secondary | Frequency of Serious vaccine/CTL Events | Frequency of Serious vaccine/CTL Events | Measured from Day 0 through Day 28 |