Treat and Prevent Covid-19 Infection Clinical Trial
Official title:
Safety and Immunity Evaluation of A Covid-19 Coronavirus Artificial Antigen Presenting Cell Vaccine
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.
| 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: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Shenzhen Geno-immune Medical Institute | 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 | Frequency of vaccine events | Frequency of vaccine events such as fever, rash, and abnormal heart function. | Measured from Day 0 through Day 28 | |
| Primary | Frequency of serious vaccine events | Frequency of serious vaccine events | Measured from Day 0 through Day 28 | |
| Primary | Proportion of subjects with positive T cell response | 14 and 28 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 if applicable | Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up | Measured from Day 0 through Day 28 | |
| 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 | Clinical improvement based on the 7-point scale if applicable | 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 | |
| Secondary | Lower Murray lung injury score if applicable | 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 |