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Study of COVID-19 DNA Vaccine (AG0301-COVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04463472
Recruitment Status : Active, not recruiting
First Posted : July 9, 2020
Last Update Posted : November 16, 2020
Sponsor:
Collaborator:
Japan Agency for Medical Research and Development
Information provided by (Responsible Party):
AnGes, Inc.

Tracking Information
First Submitted Date  ICMJE July 8, 2020
First Posted Date  ICMJE July 9, 2020
Last Update Posted Date November 16, 2020
Actual Study Start Date  ICMJE June 29, 2020
Actual Primary Completion Date September 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Week 1 through Week 9 ]
    Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after each vaccination
  • Immunogenicity [ Time Frame: Weeks 3, 5, 7, 9 ]
    Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2020)
  • Safety (from the first dose to 8 weeks later) [ Time Frame: Week 1 through Week 9 ]
    Frequency and severity of each adverse event, solicited local and systemic AEs 14days after each vaccination
  • Immunogenicity [ Time Frame: Weeks 3, 5, 7, 9 ]
    Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike glycoprotein-specific antibody
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2020)
  • Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody [ Time Frame: Weeks 13, 25, 53 ]
  • Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody [ Time Frame: Weeks 3, 5, 7, 9, 13, 25, 53 ]
  • Change in GMT of anti-SARS-CoV-2 B cell epitope antibody [ Time Frame: Weeks 3, 5, 7, 9, 13, 25, 53 ]
  • Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody [ Time Frame: Weeks 3, 5, 7, 9, 13, 25, 53 ]
  • Adverse events [ Time Frame: Week 9 through Week 53 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of COVID-19 DNA Vaccine (AG0301-COVID19)
Official Title  ICMJE A Non-randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Two Doses of Intramuscular AG0301-COVID19 (1mg/2mg) in Healthy Adults
Brief Summary This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.
Detailed Description

This is a Phase 1/2, single-center, non-randomised, open-label, non-controlled trial. Approximately 30 healthy volunteers, male or female, aged 20-65, will be enrolled in the low dose group for the first 15 and the high dose group for the remaining 15.

Low dose group: 1.0 mg AG0301-COVID19 intramuscular (IM) (n = 15) High dose group: 2.0 mg AG0301-COVID19 IM (n = 15)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: AG0301-COVID19
    1.0 mg of AG0301-COVID19 twice at 2-week intervals
  • Biological: AG0301-COVID19
    2.0 mg of AG0301-COVID19 twice at 2-week intervals
Study Arms  ICMJE
  • Experimental: Low-dose group
    Intervention: Biological: AG0301-COVID19
  • Experimental: High-dose group
    Intervention: Biological: AG0301-COVID19
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Actual Primary Completion Date September 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects who have obtained written consent voluntarily to participate in this clinical trial
  2. Subjects whose age at the time of obtaining consent is 20 years to 65 years
  3. Subjects who are negative for SARS-CoV-2 by PCR test
  4. Subjects who are negative for both SARS-CoV-2 IgM antibody and SARS-CoV-2 IgG antibody by antibody test

Exclusion Criteria:

  1. Subjects with symptoms of suspected COVID-19 infection (respiratory symptoms, headache, malaise, olfactory disorders, taste disorders, etc.)
  2. Subjects with a history of COVID-19 (hearing from subjects)
  3. Subjects who have participated in unapproved vaccine clinical trials
  4. Subjects with axillary temperature of 37.0 degree or higher
  5. Subjects who have a history of anaphylaxis
  6. Subjects who have serious renal, liquid, respiratory, liver, kidney, digestive, and neuropsychiatric history has a current medical history
  7. Subjects with a history of convulsion or epilepsy
  8. Subjects with a history of diagnosis of immunodeficiency
  9. Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
  10. Subjects who have a history of bronchial asthma
  11. Subjects who had a fever of 39.0°C or higher within 2 days after the last vaccination, and those who suspected allergy such as a systemic rash
  12. Females who wish to become pregnant from the date of study registration to 12 weeks after the first inoculation of the investigational drug, and pregnant females who are breast-feeding. In addition, females who may become pregnant and their male sexual partners should use appropriate contraceptives (pill), condoms, vasectomy, tubal ligation, diaphragm, intrauterine devices, spermicides, intrauterine hormone-releasing system, etc. from the study entry date until 12 weeks after vaccination
  13. Subjects who have participated in clinical trials of other unapproved drugs and received the investigational drug within 4 weeks before the start of this clinical trial (starting from vaccination day)
  14. Subjects who have been received a live vaccine, inactivated vaccine, or toxoid within 4 weeks before the start of this clinical trial (starting from vaccination day)
  15. Subjects who have been administered with drugs that affect the immune system (excluding external preparations) such as immunomodulators (DMARDs, etc.), immunosuppressants, biologics, etc. within 4 weeks from vaccination
  16. Subjects who received blood transfusion or gamma globulin therapy within 12 week before vaccination, or high-dose gamma globulin therapy (200 mg/kg or more) within 24 weeks before vaccination
  17. Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
  18. Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)
  19. Subjects who are judged to be ineligible for this clinical trial by the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04463472
Other Study ID Numbers  ICMJE AG0301-COVID19-JN-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AnGes, Inc.
Study Sponsor  ICMJE AnGes, Inc.
Collaborators  ICMJE Japan Agency for Medical Research and Development
Investigators  ICMJE
Study Director: AnGes, Inc. Clinical Development AnGes, Inc.
PRS Account AnGes, Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP