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Study of COVID-19 DNA Vaccine (AG0302-COVID19)

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

AG0302-COVID19

About this trial

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

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 20 years to 65 years
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
Subjects with axillary temperature of 37.0 degree or higher
Subjects who have a history of anaphylaxis
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 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
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 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 week 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

Sites / Locations

Osaka University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after first 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 GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody

Change in GMT of anti-SARS-CoV-2 B cell epitope antibody

Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody

Change in the neutralizing activity against pseudovirus of SARS-CoV-2

Change in binding inhibition of SARS-CoV-2 spike (S) glycoprotein and ACE2

Change in IFN-γ production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells

Adverse events

Full Information

NCT ID

NCT04527081

First Posted

August 24, 2020

Last Updated

October 1, 2021

Sponsor

AnGes, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04527081

Brief Title

Study of COVID-19 DNA Vaccine (AG0302-COVID19)

Official Title

A Randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Twice or Three Times Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

August 31, 2020 (Actual)

Primary Completion Date

November 9, 2020 (Actual)

Study Completion Date

September 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AnGes, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy adult volunteers.

Detailed Description

This is a Phase 1/2, single-center, randomized, open-label, non-controlled trial. Approximately 30 healthy volunteers, male or female, aged 20-65, will be randomized to one of the following three groups. Group A: Vaccination twice at 2-week intervals (n = 10) Group B: Vaccination twice at 4-week intervals (n = 10) Group C: Vaccination 3 times at 2-week intervals (n = 10)

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 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Title

Group B

Arm Type

Experimental

Arm Title

Group C

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

AG0302-COVID19

Intervention Description

2.0 mg of AG0302-COVID19 twice at 2-week intervals

Intervention Type

Biological

Intervention Name(s)

AG0302-COVID19

Intervention Description

2.0 mg of AG0302-COVID19 twice at 4-week intervals

Intervention Type

Biological

Intervention Name(s)

AG0302-COVID19

Intervention Description

2.0 mg of AG0302-COVID19 three times at 2-week intervals

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after first vaccination

Time Frame

Week 1 through Week 9

Title

Immunogenicity

Description

Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody

Time Frame

Weeks 3, 5, 7, 9

Secondary Outcome Measure Information:

Title

Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody

Time Frame

Weeks 13, 25, 53

Title

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

Title

Change in GMT of anti-SARS-CoV-2 B cell epitope antibody

Time Frame

Week 9

Title

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

Title

Change in the neutralizing activity against pseudovirus of SARS-CoV-2

Time Frame

Weeks 3, 5, 7, 9, 13, 25, 53

Title

Change in binding inhibition of SARS-CoV-2 spike (S) glycoprotein and ACE2

Time Frame

Weeks 3, 5, 7, 9, 13, 25, 53

Title

Change in IFN-γ production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells

Time Frame

Weeks 3, 5, 7, 9, 13, 25, 53

Title

Adverse events

Time Frame

Week 9 through Week 53

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

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 20 years to 65 years 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 Subjects with axillary temperature of 37.0 degree or higher Subjects who have a history of anaphylaxis 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 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 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 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 week 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

Osaka University Hospital

City

Osaka

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of COVID-19 DNA Vaccine (AG0302-COVID19)

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