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History of Changes for Study: NCT04276896
Function and Safety Study of SARS-CoV-2 Synthetic Minigene Vaccines
Latest version (submitted March 17, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 17, 2020 None (earliest Version on record)
2 February 28, 2020 Arms and Interventions, Conditions, Study Description, Study Identification, Eligibility and Study Status
3 March 17, 2020 Study Status, Contacts/Locations and Sponsor/Collaborators
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Study NCT04276896
Submitted Date:  February 17, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: GIMI-IRB-20001
Brief Title: Function and Safety Study of SARS-CoV-2 Synthetic Minigene Vaccines
Official Title: Phase I/II Multicenter Trial of DC Vaccine and Antigen-specific Cytotoxic T Cells in the Treatment of New Coronavirus (SARS-CoV-2) Infections
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2020
Overall Status: Recruiting
Study Start: February 24, 2020
Primary Completion: July 31, 2023 [Anticipated]
Study Completion: December 31, 2024 [Anticipated]
First Submitted: February 17, 2020
First Submitted that
Met QC Criteria:
February 17, 2020
First Posted: February 19, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
February 17, 2020
Last Update Posted: February 19, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Shenzhen Geno-Immune Medical Institute
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: In December 2019, viral pneumonia caused by a novel beta-coronavirus (SARS-CoV-2) outbroke in Wuhan, China. Part of patients rapidly progress severe acute respiratory failure with substantial mortality, making it imperative to develop a safe and effective vaccine to treatment for severe SARS-CoV-2 pneumonia (Covid-19) besides the supportive care. Through detailed analyses of the viral genome sequences and potential vaccine targets of SARS-CoV-2, it has been found that the structural proteins Spike (S) and Membrane (M) of the virus have high mutation rate, while the Envelope (E), Nucleocapsid (N) and Protease (P) regions are highly conserved. 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 proteins. This trial proposes to develop innovative SARS-CoV-2 minigenes, and use an efficient lentiviral vector system (LV) and immune modulatory genes to modify dendritic cells (DCs) to establish a novel LV-DC vaccine (LV-DC/SMENP). In this study, the safety and efficacy of LV-DC vaccine (LV-DC/SMENP) will be investigated.
Detailed Description:

Background: In 2019, the new coronavirus (SARS-CoV-2) was an enveloped positive strand single strand RNA virus. The number of SARS-CoV-2 infections has increased rapidly and has the ability of human transmission. It has posed a serious threat to human health. There is no vaccine available or clinically approved antiviral therapy. This study aims to evaluate the safety and efficacy of treating SARS-CoV-2 infections with LV-DC vaccine or antigen-specific cytotoxic T Cells in pneumonia patients. Objective: Primary study objectives: Infusion of autologous LV-DC vaccine or antigen-specific cytotoxic T Cells to patients to evaluate the safety. Secondary study objectives: To evaluate the anti-Covid-19 efficacy of infused autologous LV-DC vaccine or antigen-specific cytotoxic T Cells. Design:

  1. according to the complete genome sequence of the new coronavirus SARS-CoV-2, select all important structural and protease genes, and important conserved functional region sequences, and construct use lentiviral vectors to express SARS-CoV-2 new peptide combination SMENP minigenes.
  2. LV-SARS-CoV-2-DC vaccine was made by modifying DC with lentivirus vector expressing peptide minigenes and immune stimulating regulatory gene (CNX, GM-CSF, IL-15). CTL cells from PBMC will be activated and enriched by LV-DC with SARS-CoV-2 specific antigens.
  3. LV-DC vaccine or antigen-specific cytotoxic T Cells preparation time is approximately 7~21 days. Subject will receive injaction of 5x10^6 cells of LV-DC vavccine / 1x10^8 antigen-specific cytotoxic T Cells via sub-cutaneous fluids or IV infusion. Patients are followed weekly for one month after the infusion, monthly for 3 months, and then every 3 months until the trial ends.
Open or close this module Conditions
Conditions: Pathogen Infection SARS-CoV-2 Infection
Keywords: LV-DC vaccine
SARS-CoV-2 CTL
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: LV-DC Vaccine or Antigen-specific Cytotoxic T Cells
Patients will receive approximately 5x10^6 LV-DC vaccine or 1x10^8 CTLs as a single infusion via sub-cutaneous fluids / IV injection and may receive additional infusions.
Biological: Infusion of LV-DC Vaccine or Antigen-specific Cytotoxic T Cells
Patients will receive approximately 5x10^6 LV-DC vaccine or 1x10^8 CTLs as a single infusion via sub-cutaneous fluids / IV injection and may receive additional infusions.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Clinical improvement based on the 7-point scale
[ Time Frame: 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).
2. Lower Murray lung injury score
[ Time Frame: 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.
Secondary Outcome Measures:
1. 28-day mortality
[ Time Frame: Measured from Day 0 through Day 28 ]

Number of deaths during study follow-up
2. Duration of mechanical ventilation
[ Time Frame: Measured from Day 0 through Day 28 ]

Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
3. Duration of hospitalization
[ Time Frame: Measured from Day 0 through Day 28 ]

Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
4. Proportion of patients with negative RT-PCR results
[ Time Frame: 7 and 14 days after randomization ]

Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
5. Proportion of patients in each category of the 7-point scale
[ Time Frame: 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).
6. Proportion of patients with normalized inflammation factors
[ Time Frame: 7 and 14 days after randomization ]

Proportion of patients with different inflammation factors in normalization range.
7. Frequency of vaccine/CTL Events
[ Time Frame: Measured from Day 0 through Day 28 ]

Frequency of vaccine/CTL Events
8. Frequency of Serious vaccine/CTL Events
[ Time Frame: Measured from Day 0 through Day 28 ]

Frequency of Serious vaccine/CTL Events
Open or close this module Eligibility
Minimum Age: 6 Months
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Laboratory (RT-PCR) confirmed SARS-CoV-2 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.
Open or close this module Contacts/Locations
Central Contact Person: Lung-Ji Chang, PhD
Telephone: +86(755)8672 5195
Email: c@szgimi.org
Study Officials: Lung-Ji Chang, PhD
Principal Investigator
Shenzhen Geno-Immune Medical Institute
Locations: China, Guangdong
Shenzhen Geno-immune Medical Institute
[Recruiting]
Shenzhen, Guangdong, China, 518000
Contact:Contact: Lung-Ji Chang, PhD 86-755-86725195 c@szgimi.org
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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