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

June 7, 2022 updated by: AnGes, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan, 530-0001
        • NISHI-UMEDA Clinic for Asian Medical Collaboration
      • Osaka, Japan, 532-0003
        • Medical Corporation Heishinkai OPHAC Hospital
    • Chiba
      • Narita, Chiba, Japan, 286-8520
        • UHW Narita Hospital
    • Osaka
      • Suita, Osaka, Japan, 565-0853
        • Medical Corporation Heishinkai OCROM Clinic
    • Tokyo
      • Shibuya-ku, Tokyo, Japan, 151-0053
        • Medical Corporation Tsurukamekai Shinjuku Tsurukame C linic
      • Shinjuku-ku, Tokyo, Japan, 160-0008
        • Medical Corporation Heishinkai ToCROM Clinic
      • Shinjuku-ku, Tokyo, Japan, 160-0017
        • Medical Corporation Shinanokai Shinanozaka Clinic
      • Toshima-ku, Tokyo, Japan, 171-0014
        • Sekino Clinical Pharmacology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group B (Placebo)
Biological: Group B (Placebo)
Placebo twice at 4-week intervals
Experimental: Group A (AG-0302-COVID19)
Biological: Group A (AG0302-COVID19)
2 mg of AG0302-COVID19 twice at 2-week intervals
Placebo Comparator: Group A (Placebo)
Biological: Group A (Placebo)
Placebo twice at 2-week intervals
Experimental: Group B (AG-0302-COVID19)
Biological: Group B (AG0302-COVID19)
2 mg of AG0302-COVID19 twice at 4-week intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: Group A: 6 weeks Group B: 8 weeks
Frequency and severity of each adverse event solicited local and systemic AEs from the first vaccination to 4 weeks after the second vaccination
Group A: 6 weeks Group B: 8 weeks
Immunogenicity
Time Frame: Group A: Week 7 Group B: Week 9
Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Group A: Week 7 Group B: Week 9

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Group A: Weeks 5, 25, 53 Group B: Weeks 7, 25, 53
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
Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
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
Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
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
Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
Adverse events
Time Frame: Group A: Week 7 through Week 53 Group B: Week 9 through Week 53
Group A: Week 7 through Week 53 Group B: Week 9 through Week 53
Rate of SARS-CoV-2 positive and incidence rate of COVID-19 after the first vaccination
Time Frame: Week 1 through Week 53
Week 1 through Week 53

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AnGes, Inc.

Collaborators

Japan Agency for Medical Research and Development

Investigators

  • Study Director: AnGes, Inc. Clinical Development, AnGes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2020

Primary Completion (Actual)

April 2, 2021

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

November 26, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG0302-COVID19-JN-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Group A (AG0302-COVID19)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe