Study of COVID-19 DNA Vaccine (AG0301-COVID19)

NCT04463472 | Completed Phase 1

• 1 other identifier: AG0301-COVID19-JN-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the safety and immunogenicity of AG0301-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 [Safety and Tolerability]

  Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after first vaccination

  Week 1 through Week 9

• Immunogenicity

  Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody

  Weeks 3, 5, 7, 9

Secondary Outcomes (5)

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

  Weeks 13, 25, 53

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

  Weeks 3, 5, 7, 9, 13, 25, 53

• Change in GMT of anti-SARS-CoV-2 B cell epitope antibody

  Weeks 3, 5, 7, 9, 13, 25, 53

• Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody

  Weeks 3, 5, 7, 9, 13, 25, 53

• Adverse events

  Week 9 through Week 53

Study Arms (2)

Low-dose group

EXPERIMENTAL

Biological: AG0301-COVID19

High-dose group

EXPERIMENTAL

Biological: AG0301-COVID19

Interventions

AG0301-COVID19 BIOLOGICAL

1.0 mg of AG0301-COVID19 twice at 2-week intervals

Low-dose group

Eligibility Criteria

• Age: 20 Years - 65 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 20 years to 65 years
• 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
• Subjects with axillary temperature of 37.0 degree or higher
• Subjects who have a history of anaphylaxis
• Subjects who have serious renal, liquid, respiratory, liver, kidney, digestive, and neuropsychiatric history has a current medical history
• 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 a history of bronchial asthma
• Subjects who had a fever of 39.0°C or higher within 2 days after the last vaccination, and those who suspected allergy such as a systemic rash
• Females who wish to become pregnant from the date of study registration to 12 weeks after the first inoculation of the investigational drug, 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 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)
• 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 from vaccination

Sponsors & Collaborators

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

Study Sites (1)

Osaka City University Hospital

Osaka, 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 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 9, 2020
• Study Start: June 29, 2020
• Primary Completion: September 28, 2020
• Study Completion: August 12, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)