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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 : August 24, 2020
Sponsor:
Collaborator:
Japan Agency for Medical Research and Development
Information provided by (Responsible Party):
AnGes, Inc.

Study Description
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Brief Summary:
This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: AG0301-COVID19 Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : September 26, 2020
Estimated Study Completion Date : July 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Low-dose group Biological: AG0301-COVID19
1.0 mg of AG0301-COVID19 twice at 2-week intervals

Experimental: High-dose group Biological: AG0301-COVID19
2.0 mg of AG0301-COVID19 twice at 2-week intervals



Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody [ Time Frame: Weeks 13, 25, 53 ]
  2. 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 ]
  3. Change in GMT of anti-SARS-CoV-2 B cell epitope antibody [ Time Frame: Weeks 3, 5, 7, 9, 13, 25, 53 ]
  4. 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 ]
  5. Adverse events [ Time Frame: Week 9 through Week 53 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04463472


Locations
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Japan
Osaka City University Hospital
Osaka, Japan
Sponsors and Collaborators
AnGes, Inc.
Japan Agency for Medical Research and Development
Investigators
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Study Director: AnGes, Inc. Clinical Development AnGes, Inc.
More Information
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Responsible Party: AnGes, Inc.
ClinicalTrials.gov Identifier: NCT04463472    
Other Study ID Numbers: AG0301-COVID19-JN-01
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AnGes, Inc.:
vaccine
COVID-19
SARS-CoV-2