COVID-19Phase 1/2NCT04463472
Study of COVID-19 DNA Vaccine (AG0301-COVID19)
A Phase 1/2 study testing AG0301-COVID19 in people with COVID-19, run by AnGes, Inc. at 1 site in Japan.
Trial summary
This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- AG0301-COVID19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 29 Jun 2020to 12 Aug 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Two Doses of Intramuscular AG0301-COVID19 (1mg/2mg) in Healthy Adults
This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.
Read the detailed description
This is a Phase 1/2, single-center, non-randomised, open-label, non-controlled trial. Approximately 30 healthy volunteers, male or female, aged 20-65, will be enrolled in the low dose group for the first 15 and the high dose group for the remaining 15.
Low dose group: 1.0 mg AG0301-COVID19 intramuscular (IM) (n = 15) High dose group: 2.0 mg AG0301-COVID19 IM (n = 15)
- Conditions
- COVID-19
- Being tested
- AG0301-COVID19
- Keywords
- vaccine, COVID-19, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG0301-COVID19Biological
1.0 mg of AG0301-COVID19 twice at 2-week intervals
AG0301-COVID19Biological
2.0 mg of AG0301-COVID19 twice at 2-week intervals
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | Not described Receives: Biological: AG0301-COVID19 |
| High-dose group | Experimental | Not described Receives: Biological: AG0301-COVID19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 1 through Week 9
Immunogenicity
Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Measured: Weeks 3, 5, 7, 9
Secondary outcomes (5)
Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Measured: Weeks 13, 25, 53
Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody
Measured: Weeks 3, 5, 7, 9, 13, 25, 53
Change in GMT of anti-SARS-CoV-2 B cell epitope antibody
Measured: 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
Measured: Weeks 3, 5, 7, 9, 13, 25, 53
Adverse events
Measured: Week 9 through Week 53
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start29 Jun 2020
- Primary completion28 Sep 2020
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnGes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Japan Agency for Medical Research and Development
- Responsible party
- Sponsor
- Investigators
- AnGes, Inc. Clinical Development, Study director, AnGes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463472
- Sponsor's protocol ID
- AG0301-COVID19-JN-01
- Status last verified
- Aug 2021
- First submitted
- 8 Jul 2020
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Two Doses of Intramuscular AG0301-COVID19 (1mg/2mg) in Healthy Adults
- ClinicalTrials.gov ID
- NCT04463472
- Acronym / sponsor ID
- AG0301-COVID19-JN-01
- Conditions
- COVID-19
- Keywords
- vaccine, COVID-19, SARS-CoV-2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AnGes, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Japan Agency for Medical Research and Development
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.
Detailed description
This is a Phase 1/2, single-center, non-randomised, open-label, non-controlled trial. Approximately 30 healthy volunteers, male or female, aged 20-65, will be enrolled in the low dose group for the first 15 and the high dose group for the remaining 15.
Low dose group: 1.0 mg AG0301-COVID19 intramuscular (IM) (n = 15) High dose group: 2.0 mg AG0301-COVID19 IM (n = 15)
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Biological: AG0301-COVID19 |
| High-dose group | Experimental | Biological: AG0301-COVID19 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG0301-COVID191.0 mg of AG0301-COVID19 twice at 2-week intervals | Biological | Low-dose group |
| AG0301-COVID192.0 mg of AG0301-COVID19 twice at 2-week intervals | Biological | High-dose group |
Primary outcome
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
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
5 secondary outcomes
Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Time frame: 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
Change in GMT of anti-SARS-CoV-2 B cell epitope antibody
Time frame: 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
Time frame: Weeks 3, 5, 7, 9, 13, 25, 53
Adverse events
Time frame: Week 9 through Week 53
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AnGes, Inc. Clinical Development study director
AnGes, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AG0301-COVID19 in people with COVID-19, run by AnGes, Inc. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Week 1 through Week 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.