- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04527081
Study of COVID-19 DNA Vaccine (AG0302-COVID19)
October 1, 2021 updated by: AnGes, Inc.
A Randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Twice or Three Times Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults
This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy adult volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a Phase 1/2, single-center, randomized, open-label, non-controlled trial. Approximately 30 healthy volunteers, male or female, aged 20-65, will be randomized to one of the following three groups.
Group A: Vaccination twice at 2-week intervals (n = 10) Group B: Vaccination twice at 4-week intervals (n = 10) Group C: Vaccination 3 times at 2-week intervals (n = 10)
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Osaka, Japan
- Osaka University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 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 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 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)
- 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
- Subjects who received blood transfusion or gamma globulin therapy within 12 week before vaccination, or high-dose gamma globulin therapy (200 mg/kg or more) within 24 weeks before vaccination
- Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
- Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)
- Subjects who are judged to be ineligible for this clinical trial by the investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
|
2.0 mg of AG0302-COVID19 twice at 2-week intervals
2.0 mg of AG0302-COVID19 twice at 4-week intervals
2.0 mg of AG0302-COVID19 three times at 2-week intervals
|
Experimental: Group B
|
2.0 mg of AG0302-COVID19 twice at 2-week intervals
2.0 mg of AG0302-COVID19 twice at 4-week intervals
2.0 mg of AG0302-COVID19 three times at 2-week intervals
|
Experimental: Group C
|
2.0 mg of AG0302-COVID19 twice at 2-week intervals
2.0 mg of AG0302-COVID19 twice at 4-week intervals
2.0 mg of AG0302-COVID19 three times at 2-week intervals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Week 1 through Week 9
|
Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after first vaccination
|
Week 1 through Week 9
|
Immunogenicity
Time Frame: Weeks 3, 5, 7, 9
|
Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
|
Weeks 3, 5, 7, 9
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Time Frame: Weeks 13, 25, 53
|
Weeks 13, 25, 53
|
Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody
Time Frame: Weeks 3, 5, 7, 9, 13, 25, 53
|
Weeks 3, 5, 7, 9, 13, 25, 53
|
Change in GMT of anti-SARS-CoV-2 B cell epitope antibody
Time Frame: Week 9
|
Week 9
|
Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Time Frame: Weeks 3, 5, 7, 9, 13, 25, 53
|
Weeks 3, 5, 7, 9, 13, 25, 53
|
Change in the neutralizing activity against pseudovirus of SARS-CoV-2
Time Frame: Weeks 3, 5, 7, 9, 13, 25, 53
|
Weeks 3, 5, 7, 9, 13, 25, 53
|
Change in binding inhibition of SARS-CoV-2 spike (S) glycoprotein and ACE2
Time Frame: Weeks 3, 5, 7, 9, 13, 25, 53
|
Weeks 3, 5, 7, 9, 13, 25, 53
|
Change in IFN-γ production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells
Time Frame: Weeks 3, 5, 7, 9, 13, 25, 53
|
Weeks 3, 5, 7, 9, 13, 25, 53
|
Adverse events
Time Frame: Week 9 through Week 53
|
Week 9 through Week 53
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: AnGes, Inc. Clinical Development, AnGes, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2020
Primary Completion (Actual)
November 9, 2020
Study Completion (Actual)
September 24, 2021
Study Registration Dates
First Submitted
August 24, 2020
First Submitted That Met QC Criteria
August 24, 2020
First Posted (Actual)
August 26, 2020
Study Record Updates
Last Update Posted (Actual)
October 4, 2021
Last Update Submitted That Met QC Criteria
October 1, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AG0302-COVID19-JN-01
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
Clinical Trials on AG0302-COVID19
-
AnGes, Inc.Japan Agency for Medical Research and DevelopmentCompletedCOVID-19 Lower Respiratory InfectionJapan
-
AnGes, Inc.Japan Agency for Medical Research and DevelopmentCompleted
-
Centre Hospitalier Régional Metz-ThionvilleRecruitingCOVID-19 | Quality of Life | Cognitive Impairment | Posttraumatic Stress Disorder | Social BehaviorFrance
-
Slavko RoganRecruiting
-
Assistance Publique - Hôpitaux de ParisRecruiting
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceRecruitingCOVID | Psychiatric DisordersFrance
-
Chinese University of Hong KongCompletedCovid19 | IgG4 Related DiseaseHong Kong
-
Scentech Medical Technologies LtdCompleted
-
University Hospital, LimogesCompletedCovid19 | Rheumatoid Arthritis | Inflammatory Arthritis | Spondyloarthritis | Inflammatory RheumatismFrance