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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 : April 8, 2021
Sponsor:
Collaborator:
Japan Agency for Medical Research and Development
Information provided by (Responsible Party):
AnGes, Inc.

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

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Group A (AG0302-COVID19) Biological: Group A (Placebo) Biological: Group B (AG0302-COVID19) Biological: Group B (Placebo) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 23, 2020
Actual Primary Completion Date : April 2, 2021
Estimated Study Completion Date : March 31, 2022

Arm Intervention/treatment
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

Placebo Comparator: Group B (Placebo) Biological: Group B (Placebo)
Placebo twice at 4-week intervals




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Adverse events [ Time Frame: Group A: Week 7 through Week 53 Group B: Week 9 through Week 53 ]
  6. Rate of SARS-CoV-2 positive and incidence rate of COVID-19 after the first vaccination [ Time Frame: Week 1 through Week 53 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (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 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

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): NCT04655625


Locations
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Japan
UHW Narita Hospital
Narita, Chiba, Japan, 286-8520
Medical Corporation Heishinkai OCROM Clinic
Suita, Osaka, Japan, 565-0853
Medical Corporation Tsurukamekai Shinjuku Tsurukame C linic
Shibuya-ku, Tokyo, Japan, 151-0053
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, Japan, 160-0008
Medical Corporation Shinanokai Shinanozaka Clinic
Shinjuku-ku, Tokyo, Japan, 160-0017
Sekino Clinical Pharmacology Clinic
Toshima-ku, Tokyo, Japan, 171-0014
NISHI-UMEDA Clinic for Asian Medical Collaboration
Osaka, Japan, 530-0001
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Japan, 532-0003
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.
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Responsible Party: AnGes, Inc.
ClinicalTrials.gov Identifier: NCT04655625    
Other Study ID Numbers: AG0302-COVID19-JN-02
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases