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
1 other identifier
interventional
422
1 country
6
Brief Summary
This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2021
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 29, 2021
CompletedFirst Submitted
Initial submission to the registry
July 30, 2021
CompletedFirst Posted
Study publicly available on registry
August 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2022
CompletedNovember 9, 2022
November 1, 2022
4 months
July 30, 2021
November 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (5)
Group A
EXPERIMENTALGroup B
EXPERIMENTALGroup C
EXPERIMENTALGroup D
EXPERIMENTALGroup E
EXPERIMENTALInterventions
Vaccination 2 mg of AG0302-COVID19 three times at 2-week intervals
Vaccination 1 mg of AG0302-COVID19 three times at 2-week intervals
Eligibility Criteria
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 with a history of vaccination for the prevention of COVID-19
- Subjects who have participated in unapproved vaccine clinical trials within 1 year before the start of this study
- Subjects with an axillary temperature of 37.5 degrees or higher at the time of screening
- Subjects with an axillary temperature of 37.5 degrees or higher 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 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AnGes, Inc.lead
- Japan Agency for Medical Research and Developmentcollaborator
Study Sites (6)
IUHW Narita Hospital
Narita, Chiba, 286-8520, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita, Osaka, 565-0853, Japan
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008, Japan
Medical Corporation Shinanokai Shinanozaka Clinic
Shinjuku-ku, Tokyo, 160-0017, Japan
Sekino Clinical Pharmacology Clinic
Toshima-ku, Tokyo, 171-0014, Japan
Medical Corporation Heishinkai OPHAC Hospital
Osaka, 532-0003, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development
AnGes, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2021
First Posted
August 6, 2021
Study Start
July 29, 2021
Primary Completion
December 10, 2021
Study Completion
September 23, 2022
Last Updated
November 9, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share