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Safety and Immunity of Covid-19 aAPC Vaccine

Primary Purpose

Treat and Prevent Covid-19 Infection

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Pathogen-specific aAPC
Sponsored by
Shenzhen Geno-Immune Medical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treat and Prevent Covid-19 Infection focused on measuring Lentiviral vector, Covid-19/aAPC vaccine

Eligibility Criteria

6 Months - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shenzhen Geno-immune Medical InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Injection of Covid-19/aAPC vaccine

Arm Description

Outcomes

Primary Outcome Measures

Frequency of vaccine events
Frequency of vaccine events such as fever, rash, and abnormal heart function.
Frequency of serious vaccine events
Frequency of serious vaccine events
Proportion of subjects with positive T cell response

Secondary Outcome Measures

28-day mortality
Number of deaths during study follow-up
Duration of mechanical ventilation if applicable
Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up
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)
Proportion of patients with normalized inflammation factors
Proportion of patients with different inflammation factors in normalization range
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)
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

Full Information

First Posted
March 5, 2020
Last Updated
March 6, 2020
Sponsor
Shenzhen Geno-Immune Medical Institute
Collaborators
Shenzhen Third People's Hospital, Shenzhen Second People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04299724
Brief Title
Safety and Immunity of Covid-19 aAPC Vaccine
Official Title
Safety and Immunity Evaluation of A Covid-19 Coronavirus Artificial Antigen Presenting Cell Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen Geno-Immune Medical Institute
Collaborators
Shenzhen Third People's Hospital, Shenzhen Second People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treat and Prevent Covid-19 Infection
Keywords
Lentiviral vector, Covid-19/aAPC vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Injection of Covid-19/aAPC vaccine
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Pathogen-specific aAPC
Intervention Description
The subjects will receive three injections of 5x10^6 each Covid-19/aAPC vaccine via subcutaneous injections.
Primary Outcome Measure Information:
Title
Frequency of vaccine events
Description
Frequency of vaccine events such as fever, rash, and abnormal heart function.
Time Frame
Measured from Day 0 through Day 28
Title
Frequency of serious vaccine events
Description
Frequency of serious vaccine events
Time Frame
Measured from Day 0 through Day 28
Title
Proportion of subjects with positive T cell response
Time Frame
14 and 28 days after randomization
Secondary Outcome Measure Information:
Title
28-day mortality
Description
Number of deaths during study follow-up
Time Frame
Measured from Day 0 through Day 28
Title
Duration of mechanical ventilation if applicable
Description
Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up
Time Frame
Measured from Day 0 through Day 28
Title
Proportion of patients in each category of the 7-point scale
Description
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)
Time Frame
7,14 and 28 days after randomization
Title
Proportion of patients with normalized inflammation factors
Description
Proportion of patients with different inflammation factors in normalization range
Time Frame
7 and 14 days after randomization
Title
Clinical improvement based on the 7-point scale if applicable
Description
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)
Time Frame
28 days after randomization
Title
Lower Murray lung injury score if applicable
Description
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
Time Frame
7 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lung-Ji Chang
Phone
+86(755)8672 5195
Email
c@szgimi.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lung-Ji Chang
Organizational Affiliation
Shenzhen Geno-Immune Medical Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen Geno-immune Medical Institute
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lung-Ji Chang
Phone
86-755-86725195
Email
c@szgimi.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Immunity of Covid-19 aAPC Vaccine

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