Phase I/II Study of COVID-19 DNA Vaccine (AG0302-COVID19 High-dose)

A Randomized, Open-label, Uncontrolled, Phase I/II Study to Assess Safety and Immunogenicity of Two or Three Dosing of Intramuscular/Intradermal AG0302-COVID19

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

Study Overview

• Status: Completed
• Conditions: COVID-19 Lower Respiratory Infection
• Intervention / Treatment: Biological: AG0302-COVID19 for Intramuscular Injection; Biological: AG0302-COVID19 for Intramuscular Injection; Biological: AG0302-COVID19 for Intramuscular Injection; Biological: AG0302-COVID19 for Intradermal Injection; Biological: AG0302-COVID19 for Intradermal Injection

Detailed Description

This is a Phase I/II, multi-center, randomized, open-label, uncontrolled trial. Approximately 400 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following five groups:

[IM Groups] Group A: Vaccination 2 mg, three times at 2-week intervals (n = 80) Group B: Vaccination 4 mg, twice at 4-week intervals (n = 80) Group C: Vaccination 8 mg, twice at 4-week intervals(n = 80)

[ID Groups] Group D: Vaccination 1 mg, three times at 2-week intervals (n = 80) Group E: Vaccination 1 mg, twice at 4-week intervals (n = 80)

• Study Type: Interventional
• Enrollment (Actual): 422
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 532-0003
    • Medical Corporation Heishinkai OPHAC Hospital
  • Chiba
    • Narita, Chiba, Japan, 286-8520
      • Iuhw Narita Hospital
  • Osaka
    • Suita, Osaka, Japan, 565-0853
      • Medical Corporation Heishinkai OCROM Clinic
  • Tokyo
    • 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

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 with a history of vaccination for the prevention of COVID-19
4. Subjects who have participated in unapproved vaccine clinical trials within 1 year before the start of this study
5. Subjects with an axillary temperature of 37.5 degrees or higher at the time of screening
6. Subjects with an axillary temperature of 37.5 degrees or higher before the first vaccination
7. Subjects who have a history of anaphylaxis
8. Subjects who have a history of hypersensitivity to the ingredients of the investigational drug
9. Subjects who have a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases
10. Subjects with a history of convulsion or epilepsy
11. Subjects with a history of diagnosis of immunodeficiency
12. Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
13. Subjects who have current bronchial asthma
14. 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.
15. Females who wish to become pregnant from the time of obtaining consent 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
16. 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)
17. 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)
18. 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
19. 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
20. Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
21. Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)
22. Subjects who are judged to be ineligible for this clinical trial by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Biological: AG0302-COVID19 for Intramuscular Injection; Vaccination 2 mg of AG0302-COVID19 three times at 2-week intervals; Biological: AG0302-COVID19 for Intramuscular Injection; Vaccination 4 mg of AG0302-COVID19 twice at 4-week intervals; Biological: AG0302-COVID19 for Intramuscular Injection; Vaccination 8 mg of AG0302-COVID19 twice at 4-week intervals
Experimental: Group B	Biological: AG0302-COVID19 for Intramuscular Injection; Vaccination 2 mg of AG0302-COVID19 three times at 2-week intervals; Biological: AG0302-COVID19 for Intramuscular Injection; Vaccination 4 mg of AG0302-COVID19 twice at 4-week intervals; Biological: AG0302-COVID19 for Intramuscular Injection; Vaccination 8 mg of AG0302-COVID19 twice at 4-week intervals
Experimental: Group C	Biological: AG0302-COVID19 for Intramuscular Injection; Vaccination 2 mg of AG0302-COVID19 three times at 2-week intervals; Biological: AG0302-COVID19 for Intramuscular Injection; Vaccination 4 mg of AG0302-COVID19 twice at 4-week intervals; Biological: AG0302-COVID19 for Intramuscular Injection; Vaccination 8 mg of AG0302-COVID19 twice at 4-week intervals
Experimental: Group D	Biological: AG0302-COVID19 for Intradermal Injection; Vaccination 1 mg of AG0302-COVID19 three times at 2-week intervals; Biological: AG0302-COVID19 for Intradermal Injection; Vaccination 1 mg of AG0302-COVID19 twice at 4-week intervals
Experimental: Group E	Biological: AG0302-COVID19 for Intradermal Injection; Vaccination 1 mg of AG0302-COVID19 three times at 2-week intervals; Biological: AG0302-COVID19 for Intradermal Injection; Vaccination 1 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	Frequency and severity of each adverse event, solicited local and systemic AEs from the first vaccination to 12 weeks after first vaccination	Week 1 through Week 13
Immunogenicity	Change in the neutralizing activity against pseudovirus of SARS-CoV-2 [ID50]	Week 13
Immunogenicity	Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody	Week 13

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of SARS-CoV-2 positive and incidence rate of COVID-19 after the first vaccination	Week 1 through Week 53
Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody	Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53
Change in the neutralizing activity against pseudovirus of SARS-CoV-2	Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53
Seroconversion rate from baseline (defined as a 4-fold or greater increase) in the neutralizing activity against pseudovirus of SARS-CoV-2 [ID50]	Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53
Change in IFN-gamma production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells	Weeks 5, 7, 9, 13
IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody	Weeks 1, 9, 13
Adverse events	Week 13 through Week 53
Rate of swelling and leakage of the drug to the vaccination site during intradermal vaccination	Weeks 1, 3, 5
Number of defects in preparation and vaccination during intradermal vaccination	Week 1 through Week 5

Collaborators and Investigators

• Sponsor: AnGes, Inc.
• Collaborators: Japan Agency for Medical Research and Development
• Investigators: Study Director: Clinical Development, AnGes, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2021
• Primary Completion (Actual): December 10, 2021
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; vaccine; COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Tract Infections
• Other Study ID Numbers: AG0302-COVID19-JN-03

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