此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Safety and Immunity of Covid-19 aAPC Vaccine

2026年11月1日 更新者：Lung-Ji Chang、Shenzhen Geno-Immune Medical Institute

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.

研究概览

地位

终止

条件

干预/治疗

详细说明

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.

Design:

  1. Based on the genomic sequence of the new coronavirus SARS-CoV-2, select conserved and critical structural and protease protein domains to engineer lentiviral minigenes to express SARS-CoV-2 antigens.
  2. The Covid-19/aAPC vaccine is prepared by applying lentivirus modification including immune modulatory genes and the viral minigenes, to the artificial antigen presenting cells (aAPCs). The Covid-19/aAPCs are then inactivated for proliferation and extensively safety tested.
  3. The subjects receive a total of 5x10^ 6 cells each time by subcutaneous injection at 0, 14 and 28 days. The subjects are followed-up with peripheral blood tests at 0, 14, 21, 28 and 60 days until the end of the test.

研究类型

介入性

注册 (实际的)

100

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Guangdong
      • Shenzhen、Guangdong、中国、518000
        • Shenzhen Geno-immune Medical Institute

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6个月 至 80年 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Injection of Covid-19/aAPC vaccine
生物：Pathogen-specific aAPC

The subjects will receive three injections of 5x10^6 each Covid-19/aAPC vaccine via subcutaneous injections.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of subjects with positive T cell response
大体时间：14 and 28 days after randomization
14 and 28 days after randomization
Frequency of vaccine events
大体时间：Measured from Day 0 through Day 28

Frequency of vaccine events such as fever, rash, and abnormal heart function.
Measured from Day 0 through Day 28
Frequency of serious vaccine events
大体时间：Measured from Day 0 through Day 28

Frequency of serious vaccine events
Measured from Day 0 through Day 28

次要结果测量

结果测量
措施说明
大体时间
28-day mortality
大体时间：Measured from Day 0 through Day 28

Number of deaths during study follow-up
Measured from Day 0 through Day 28
Duration of mechanical ventilation if applicable
大体时间：Measured from Day 0 through Day 28

Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up
Measured from Day 0 through Day 28
Proportion of patients in each category of the 7-point scale
大体时间：7,14 and 28 days after randomization

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
Proportion of patients with normalized inflammation factors
大体时间：7 and 14 days after randomization

Proportion of patients with different inflammation factors in normalization range
7 and 14 days after randomization
Clinical improvement based on the 7-point scale if applicable
大体时间：28 days after randomization

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
Lower Murray lung injury score if applicable
大体时间：7 days after randomization

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shenzhen Geno-Immune Medical Institute

调查人员

  • 首席研究员：Lung-Ji Chang、Shenzhen Geno-Immune Medical Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (实际的)

2026年7月1日

研究完成 (实际的)

2026年7月31日

研究注册日期

首次提交

2020年3月5日

首先提交符合 QC 标准的

2020年3月6日

首次发布 (实际的)

2020年3月9日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月1日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • GIMI-IRB-20002

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅