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

NCT04655625 | Completed Phase 2

• 1 other identifier: AG0302-COVID19-JN-02
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

COVID-19

Keywords

vaccine; COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  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

  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 Outcomes (6)

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

  Group A: Weeks 5, 25, 53 Group B: Weeks 7, 25, 53

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

  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

  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

  Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53

• Adverse events

  Group A: Week 7 through Week 53 Group B: Week 9 through Week 53

Study Arms (4)

Group A (AG-0302-COVID19)

EXPERIMENTAL

Biological: Group A (AG0302-COVID19)

Group A (Placebo)

PLACEBO COMPARATOR

Biological: Group A (Placebo)

Group B (AG-0302-COVID19)

EXPERIMENTAL

Biological: Group B (AG0302-COVID19)

Group B (Placebo)

PLACEBO COMPARATOR

Biological: Group B (Placebo)

Interventions

Group A (AG0302-COVID19) BIOLOGICAL

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

Group A (AG-0302-COVID19)

Group A (Placebo) BIOLOGICAL

Placebo twice at 2-week intervals

Group A (Placebo)

Group B (AG0302-COVID19) BIOLOGICAL

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

Group B (AG-0302-COVID19)

Group B (Placebo) BIOLOGICAL

Placebo twice at 4-week intervals

Group B (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have obtained written consent voluntarily to participate in this clinical trial
• Subjects whose age at the time of obtaining consent is 18 years or older
• 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

You may not qualify if:

• 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 within 1 year before the start of this study
• Subjects with axillary temperature of 37.0 degree or higher at the time of screening and before the first vaccination
• Subjects who have a history of anaphylaxis
• Subjects who have a history of hypersensitivity to the ingredients of the investigational drug
• 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 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.
• 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
• 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)

Sponsors & Collaborators

• AnGes, Inc.: lead
• Japan Agency for Medical Research and Development: collaborator

Study Sites (8)

UHW Narita Hospital

Narita, Chiba, 286-8520, Japan

Location

Medical Corporation Heishinkai OCROM Clinic

Suita, Osaka, 565-0853, Japan

Location

Medical Corporation Tsurukamekai Shinjuku Tsurukame C linic

Shibuya-ku, Tokyo, 151-0053, Japan

Location

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Tokyo, 160-0008, Japan

Location

Medical Corporation Shinanokai Shinanozaka Clinic

Shinjuku-ku, Tokyo, 160-0017, Japan

Location

Sekino Clinical Pharmacology Clinic

Toshima-ku, Tokyo, 171-0014, Japan

Location

NISHI-UMEDA Clinic for Asian Medical Collaboration

Osaka, 530-0001, Japan

Location

Medical Corporation Heishinkai OPHAC Hospital

Osaka, 532-0003, Japan

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• AnGes, Inc. Clinical Development

  AnGes, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 7, 2020
• Study Start: November 23, 2020
• Primary Completion: April 2, 2021
• Study Completion: February 1, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (8)