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Phase II / III Study of COVID-19 DNA Vaccine (AG0302-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: NCT04655625
Recruitment Status : Active, not recruiting
First Posted : December 7, 2020
Last Update Posted : February 18, 2021
Sponsor:
Collaborator:
Japan Agency for Medical Research and Development
Information provided by (Responsible Party):
AnGes, Inc.

Tracking Information
First Submitted Date  ICMJE November 26, 2020
First Posted Date  ICMJE December 7, 2020
Last Update Posted Date February 18, 2021
Actual Study Start Date  ICMJE November 23, 2020
Estimated Primary Completion Date May 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Adverse events [ Time Frame: 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 ]
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 Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: Group A (AG0302-COVID19)
    2 mg of AG0302-COVID19 twice at 2-week intervals
  • Biological: Group A (Placebo)
    Placebo twice at 2-week intervals
  • Biological: Group B (AG0302-COVID19)
    2 mg of AG0302-COVID19 twice at 4-week intervals
  • Biological: Group B (Placebo)
    Placebo twice at 4-week intervals
Study Arms  ICMJE
  • Experimental: Group A (AG-0302-COVID19)
    Intervention: Biological: Group A (AG0302-COVID19)
  • Placebo Comparator: Group A (Placebo)
    Intervention: Biological: Group A (Placebo)
  • Experimental: Group B (AG-0302-COVID19)
    Intervention: Biological: Group B (AG0302-COVID19)
  • Placebo Comparator: Group B (Placebo)
    Intervention: Biological: Group B (Placebo)
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
Actual Enrollment  ICMJE
 (submitted: December 4, 2020)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date May 27, 2021   (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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT04655625
Other Study ID Numbers  ICMJE AG0302-COVID19-JN-02
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 February 2021

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