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Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Group A (AG0302-COVID19)
Group A (Placebo)
Group B (AG0302-COVID19)
Group B (Placebo)
Sponsored by
AnGes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring vaccine, COVID-19, SARS-CoV-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 18 years or older
  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 within 1 year before the start of this study
  4. Subjects with axillary temperature of 37.0 degree or higher at the time of screening and before the first vaccination
  5. Subjects who have a history of anaphylaxis
  6. Subjects who have a history of hypersensitivity to the ingredients of the investigational drug
  7. Subjects who have a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases
  8. Subjects with a history of convulsion or epilepsy
  9. Subjects with a history of diagnosis of immunodeficiency
  10. Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
  11. Subjects who have current bronchial asthma
  12. Subjects who have had a fever of 39.0 degrees or higher within 2 days after vaccination, or who have been suspected of having an allergy such as a systemic rash.
  13. Females who wish to become pregnant from the study registration to 12 weeks after the first vaccination, 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 the first vaccination
  14. 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)
  15. 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)
  16. 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 before vaccination
  17. Subjects who received blood transfusion or gamma globulin therapy within 12 weeks before vaccination, or high-dose gamma globulin therapy (200 mg/kg or more) within 24 weeks before vaccination
  18. Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
  19. Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)
  20. Subjects who are judged to be ineligible for this clinical trial by the investigator

Sites / Locations

  • UHW Narita Hospital
  • Medical Corporation Heishinkai OCROM Clinic
  • Medical Corporation Tsurukamekai Shinjuku Tsurukame C linic
  • Medical Corporation Heishinkai ToCROM Clinic
  • Medical Corporation Shinanokai Shinanozaka Clinic
  • Sekino Clinical Pharmacology Clinic
  • NISHI-UMEDA Clinic for Asian Medical Collaboration
  • Medical Corporation Heishinkai OPHAC Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Group A (AG-0302-COVID19)

Group A (Placebo)

Group B (AG-0302-COVID19)

Group B (Placebo)

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events
Frequency and severity of each adverse event solicited local and systemic AEs from the first vaccination to 4 weeks after the second vaccination
Immunogenicity
Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody

Secondary Outcome Measures

Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Change in the neutralizing activity against pseudovirus of SARS-CoV-2
Change in IFN-gamma production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells
IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Adverse events
Rate of SARS-CoV-2 positive and incidence rate of COVID-19 after the first vaccination

Full Information

First Posted
November 26, 2020
Last Updated
June 7, 2022
Sponsor
AnGes, Inc.
Collaborators
Japan Agency for Medical Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04655625
Brief Title
Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)
Official Title
A Randomized, Double-blind, Placebo Controlled Phase II / III Study to Assess Safety, Immunogenicity and Efficacy of Twice Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 23, 2020 (Actual)
Primary Completion Date
April 2, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AnGes, Inc.
Collaborators
Japan Agency for Medical Research and Development

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
This study will assess the safety, immunogenicity and efficacy of AG0302-COVID19 in healthy adult volunteers.
Detailed Description
This is a Phase II /III, multi-center, randomized, double-blind, placebo controlled trial. Approximately 500 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following two groups: Group A: Vaccination twice at 2-week intervals (n = 250) Group B: Vaccination twice at 4-week intervals (n = 250) Fifty subjects in each group will receive placebos.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
vaccine, COVID-19, SARS-CoV-2

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (AG-0302-COVID19)
Arm Type
Experimental
Arm Title
Group A (Placebo)
Arm Type
Placebo Comparator
Arm Title
Group B (AG-0302-COVID19)
Arm Type
Experimental
Arm Title
Group B (Placebo)
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Group A (AG0302-COVID19)
Intervention Description
2 mg of AG0302-COVID19 twice at 2-week intervals
Intervention Type
Biological
Intervention Name(s)
Group A (Placebo)
Intervention Description
Placebo twice at 2-week intervals
Intervention Type
Biological
Intervention Name(s)
Group B (AG0302-COVID19)
Intervention Description
2 mg of AG0302-COVID19 twice at 4-week intervals
Intervention Type
Biological
Intervention Name(s)
Group B (Placebo)
Intervention Description
Placebo twice at 4-week intervals
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Frequency and severity of each adverse event solicited local and systemic AEs from the first vaccination to 4 weeks after the second vaccination
Time Frame
Group A: 6 weeks Group B: 8 weeks
Title
Immunogenicity
Description
Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Time Frame
Group A: Week 7 Group B: Week 9
Secondary Outcome Measure Information:
Title
Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Time Frame
Group A: Weeks 5, 25, 53 Group B: Weeks 7, 25, 53
Title
Change in the neutralizing activity against pseudovirus of SARS-CoV-2
Time Frame
Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
Title
Change in IFN-gamma production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells
Time Frame
Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
Title
IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Time Frame
Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
Title
Adverse events
Time Frame
Group A: Week 7 through Week 53 Group B: Week 9 through Week 53
Title
Rate of SARS-CoV-2 positive and incidence rate of COVID-19 after the first vaccination
Time Frame
Week 1 through Week 53

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects who have obtained written consent voluntarily to participate in this clinical trial Subjects whose age at the time of obtaining consent is 18 years or older Subjects who are negative for SARS-CoV-2 by PCR test Subjects who are negative for both SARS-CoV-2 IgM antibody and SARS-CoV-2 IgG antibody by antibody test Exclusion Criteria: Subjects with symptoms of suspected COVID-19 infection (respiratory symptoms, headache, malaise, olfactory disorders, taste disorders, etc.) Subjects with a history of COVID-19 (hearing from subjects) Subjects who have participated in unapproved vaccine clinical trials within 1 year before the start of this study Subjects with axillary temperature of 37.0 degree or higher at the time of screening and before the first vaccination Subjects who have a history of anaphylaxis Subjects who have a history of hypersensitivity to the ingredients of the investigational drug Subjects who have a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases Subjects with a history of convulsion or epilepsy Subjects with a history of diagnosis of immunodeficiency Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency Subjects who have current bronchial asthma Subjects who have had a fever of 39.0 degrees or higher within 2 days after vaccination, or who have been suspected of having an allergy such as a systemic rash. Females who wish to become pregnant from the study registration to 12 weeks after the first vaccination, 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 the first vaccination 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) 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) 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 before vaccination Subjects who received blood transfusion or gamma globulin therapy within 12 weeks before vaccination, or high-dose gamma globulin therapy (200 mg/kg or more) within 24 weeks before vaccination Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day) Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons) Subjects who are judged to be ineligible for this clinical trial by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AnGes, Inc. Clinical Development
Organizational Affiliation
AnGes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UHW Narita Hospital
City
Narita
State/Province
Chiba
ZIP/Postal Code
286-8520
Country
Japan
Facility Name
Medical Corporation Heishinkai OCROM Clinic
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
Medical Corporation Tsurukamekai Shinjuku Tsurukame C linic
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
151-0053
Country
Japan
Facility Name
Medical Corporation Heishinkai ToCROM Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Facility Name
Medical Corporation Shinanokai Shinanozaka Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0017
Country
Japan
Facility Name
Sekino Clinical Pharmacology Clinic
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
171-0014
Country
Japan
Facility Name
NISHI-UMEDA Clinic for Asian Medical Collaboration
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
Medical Corporation Heishinkai OPHAC Hospital
City
Osaka
ZIP/Postal Code
532-0003
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)

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