COVID-19Phase 2/3NCT04655625
Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)
A Phase 2/3 study testing Group A (AG0302-COVID19) and Group B (AG0302-COVID19) in people with COVID-19, run by AnGes, Inc. at 8 sites in Japan.
Trial summary
This study will assess the safety, immunogenicity and efficacy of AG0302-COVID19 in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Group A (AG0302-COVID19) and Group B (AG0302-COVID19)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 8 sitesJapan
- Study dates
- 23 Nov 2020to 1 Feb 2022
- Phase
- Phase 2/3
- 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 18 years and older
- 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 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
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 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
Show all 20Show fewer
- 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)
- 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 weeks 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
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
UHW Narita Hospital
Narita, Chiba, 286-8520
NISHI-UMEDA Clinic for Asian Medical Collaboration
Osaka, 530-0001
Medical Corporation Heishinkai OPHAC Hospital
Osaka, 532-0003
Medical Corporation Tsurukamekai Shinjuku Tsurukame C linic
Shibuya-ku, Tokyo, 151-0053
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008
Medical Corporation Shinanokai Shinanozaka Clinic
Shinjuku-ku, Tokyo, 160-0017
Medical Corporation Heishinkai OCROM Clinic
Suita, Osaka, 565-0853
Sekino Clinical Pharmacology Clinic
Toshima-ku, Tokyo, 171-0014
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Phase II / III Study to Assess Safety, Immunogenicity and Efficacy of Twice Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults
This study will assess the safety, immunogenicity and efficacy of AG0302-COVID19 in healthy adult volunteers.
Read the detailed description
This is a Phase II /III, multi-center, randomized, double-blind, placebo controlled trial. Approximately 500 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following two groups:
Group A: Vaccination twice at 2-week intervals (n = 250) Group B: Vaccination twice at 4-week intervals (n = 250)
Fifty subjects in each group will receive placebos.
- Conditions
- COVID-19
- Being tested
- Group A (AG0302-COVID19), Group A (Placebo), Group B (AG0302-COVID19), Group B (Placebo)
- 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.
Group A (AG0302-COVID19)Biological
2 mg of AG0302-COVID19 twice at 2-week intervals
Group A (Placebo)Biological
Placebo twice at 2-week intervals
Group B (AG0302-COVID19)Biological
2 mg of AG0302-COVID19 twice at 4-week intervals
Group B (Placebo)Biological
Placebo twice at 4-week intervals
| Study group | Role | What they receive |
|---|---|---|
| Group A (AG-0302-COVID19) | Experimental | Not described Receives: Biological: Group A (AG0302-COVID19) |
| Group A (Placebo) | Placebo comparator | Not described Receives: Biological: Group A (Placebo) |
| Group B (AG-0302-COVID19) | Experimental | Not described Receives: Biological: Group B (AG0302-COVID19) |
| Group B (Placebo) | Placebo comparator | Not described Receives: Biological: Group B (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Group A: Week 7 Group B: Week 9
Secondary outcomes (6)
Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Measured: Group A: Weeks 5, 25, 53 Group B: Weeks 7, 25, 53
Change in the neutralizing activity against pseudovirus of SARS-CoV-2
Measured: 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
Measured: 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
Measured: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
Adverse events
Measured: Group A: Week 7 through Week 53 Group B: Week 9 through Week 53
Rate of SARS-CoV-2 positive and incidence rate of COVID-19 after the first vaccination
Measured: Week 1 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 posted7 Dec 2020
- Study start23 Nov 2020
- Primary completion2 Apr 2021
- Study completion1 Feb 2022
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 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
- NCT04655625
- Sponsor's protocol ID
- AG0302-COVID19-JN-02
- Status last verified
- Jun 2022
- First submitted
- 26 Nov 2020
- Last updated
- 8 Jun 2022
- 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 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Phase II / III Study to Assess Safety, Immunogenicity and Efficacy of Twice Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults
- ClinicalTrials.gov ID
- NCT04655625
- Acronym / sponsor ID
- AG0302-COVID19-JN-02
- Conditions
- COVID-19
- Keywords
- vaccine, COVID-19, SARS-CoV-2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- AnGes, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Japan Agency for Medical Research and Development
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 7 Dec 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, immunogenicity and efficacy of AG0302-COVID19 in healthy adult volunteers.
Detailed description
This is a Phase II /III, multi-center, randomized, double-blind, placebo controlled trial. Approximately 500 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following two groups:
Group A: Vaccination twice at 2-week intervals (n = 250) Group B: Vaccination twice at 4-week intervals (n = 250)
Fifty subjects in each group will receive placebos.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- 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 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
Key exclusion criteria (20 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 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
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 |
|---|---|---|
| Group A (AG0302-COVID19)2 mg of AG0302-COVID19 twice at 2-week intervals | Biological | Group A (AG-0302-COVID19) |
| Group A (Placebo)Placebo twice at 2-week intervals | Biological | Group A (Placebo) |
| Group B (AG0302-COVID19)2 mg of AG0302-COVID19 twice at 4-week intervals | Biological | Group B (AG-0302-COVID19) |
| Group B (Placebo)Placebo twice at 4-week intervals | Biological | Group B (Placebo) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Group A: 6 weeks Group B: 8 weeks
Frequency and severity of each adverse event solicited local and systemic AEs from the first vaccination to 4 weeks after the second vaccination
Immunogenicity
Time frame: Group A: Week 7 Group B: Week 9
Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
6 secondary outcomes
Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Time frame: Group A: Weeks 5, 25, 53 Group B: Weeks 7, 25, 53
Change in the neutralizing activity against pseudovirus of SARS-CoV-2
Time frame: 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
Time frame: 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
Time frame: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
Adverse events
Time frame: Group A: Week 7 through Week 53 Group B: Week 9 through Week 53
Rate of SARS-CoV-2 positive and incidence rate of COVID-19 after the first vaccination
Time frame: Week 1 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 8 Jun 2022.
- 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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Group A (AG0302-COVID19) and Group B (AG0302-COVID19) in people with COVID-19, run by AnGes, Inc. at 8 sites 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 20 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 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (time frame: Group A: 6 weeks Group B: 8 weeks). 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 8 Jun 2022.