Safety and Immunity Evaluation of A Covid-19 Coronavirus Artificial Antigen Presenting Cell Vaccine
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of subjects with positive T cell response
研究概览
简要总结
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.
详细描述
Background:
The 2019 discovered new coronavirus, SARS-CoV-2, is an enveloped positive strand single strand RNA virus. The number of SARS-CoV-2 infected people has increased rapidly and WHO has warned that the pandemic spread of Covid-19 is imminent and would have disastrous outcomes. Covid-19 could pose a serious threat to human health and the global economy. There is no vaccine available or clinically approved antiviral therapy as yet. This study aims to evaluate the safety and immune reactivity of a genetically modified aAPC universal vaccine to treat and prevent Covid-19.
Objective:
Primary study objectives: Injection of Covid-19/aAPC vaccine to volunteers to evaluate the safety.
Secondary study objectives: To evaluate the anti- Covid-19 reactivity of the Covid-19/aAPC vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
Injection of Covid-19/aAPC vaccine
干预措施: Pathogen-specific aAPC (Biological)
结局指标
主要结局
Proportion of subjects with positive T cell response
时间窗: 14 and 28 days after randomization
Frequency of serious vaccine events
时间窗: Measured from Day 0 through Day 28
Frequency of serious vaccine events
Frequency of vaccine events
时间窗: Measured from Day 0 through Day 28
Frequency of vaccine events such as fever, rash, and abnormal heart function.
次要结局
- 28-day mortality(Measured from Day 0 through Day 28)
- Duration of mechanical ventilation if applicable(Measured from Day 0 through Day 28)
- Proportion of patients with normalized inflammation factors(7 and 14 days after randomization)
- Proportion of patients in each category of the 7-point scale(7,14 and 28 days after randomization)
- Clinical improvement based on the 7-point scale if applicable(28 days after randomization)
- Lower Murray lung injury score if applicable(7 days after randomization)
研究者
Lung-Ji Chang
President
Shenzhen Geno-Immune Medical Institute