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COVID-19 Lower Respiratory InfectionPhase 1/2NCT04993586

Phase I/II Study of COVID-19 DNA Vaccine (AG0302-COVID19 High-dose)

A Phase 1/2 study testing AG0302-COVID19 for Intramuscular Injection and AG0302-COVID19 for Intradermal Injection in people with COVID-19 Lower Respiratory Infection, run by AnGes, Inc. at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy 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 Lower Respiratory Infection
What is being tested?
AG0302-COVID19 for Intramuscular Injection and AG0302-COVID19 for Intradermal Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
422 participants
Where
6 sitesJapan
Study dates
29 Jul 2021to 23 Sep 2022
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 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 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
Show all 22Show fewer
  • 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
  • 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

6 sites in 1 country.

6 sites in 1 country

Japan6 sites

  • IUHW Narita Hospital

    Narita, Chiba, 286-8520

  • Medical Corporation Heishinkai OPHAC Hospital

    Osaka, 532-0003

  • 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

Other trials in Japan

About this study

Official title: A Randomized, Open-label, Uncontrolled, Phase I/II Study to Assess Safety and Immunogenicity of Two or Three Dosing of Intramuscular/Intradermal AG0302-COVID19

This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy volunteers.

Read the detailed description

This is a Phase I/II, multi-center, randomized, open-label, uncontrolled trial. Approximately 400 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following five groups:

[IM Groups] Group A: Vaccination 2 mg, three times at 2-week intervals (n = 80) Group B: Vaccination 4 mg, twice at 4-week intervals (n = 80) Group C: Vaccination 8 mg, twice at 4-week intervals(n = 80)

[ID Groups] Group D: Vaccination 1 mg, three times at 2-week intervals (n = 80) Group E: Vaccination 1 mg, twice at 4-week intervals (n = 80)

Being tested
AG0302-COVID19 for Intramuscular Injection, AG0302-COVID19 for Intradermal Injection
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.

  • AG0302-COVID19 for Intramuscular InjectionBiological

    Vaccination 2 mg of AG0302-COVID19 three times at 2-week intervals

  • AG0302-COVID19 for Intramuscular InjectionBiological

    Vaccination 4 mg of AG0302-COVID19 twice at 4-week intervals

  • AG0302-COVID19 for Intramuscular InjectionBiological

    Vaccination 8 mg of AG0302-COVID19 twice at 4-week intervals

  • AG0302-COVID19 for Intradermal InjectionBiological

    Vaccination 1 mg of AG0302-COVID19 three times at 2-week intervals

  • AG0302-COVID19 for Intradermal InjectionBiological

    Vaccination 1 mg of AG0302-COVID19 twice at 4-week intervals

Study groups in NCT04993586
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Biological: AG0302-COVID19 for Intramuscular Injection
Group BExperimentalNot described
Receives: Biological: AG0302-COVID19 for Intramuscular Injection
Group CExperimentalNot described
Receives: Biological: AG0302-COVID19 for Intramuscular Injection
Group DExperimentalNot described
Receives: Biological: AG0302-COVID19 for Intradermal Injection
Group EExperimentalNot described
Receives: Biological: AG0302-COVID19 for Intradermal Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 1 through Week 13

  2. Immunogenicity

    Change in the neutralizing activity against pseudovirus of SARS-CoV-2 [ID50]

    Measured: Week 13

  3. Immunogenicity

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

    Measured: Week 13

Secondary outcomes (9)

  1. Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody

    Measured: Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53

  2. Change in the neutralizing activity against pseudovirus of SARS-CoV-2

    Measured: Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53

  3. Seroconversion rate from baseline (defined as a 4-fold or greater increase) in the neutralizing activity against pseudovirus of SARS-CoV-2 [ID50]

    Measured: Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53

  4. Change in IFN-gamma production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells

    Measured: Weeks 5, 7, 9, 13

  5. IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody

    Measured: Weeks 1, 9, 13

  6. Adverse events

    Measured: Week 13 through Week 53

  7. Rate of SARS-CoV-2 positive and incidence rate of COVID-19 after the first vaccination

    Measured: Week 1 through Week 53

  8. Rate of swelling and leakage of the drug to the vaccination site during intradermal vaccination

    Measured: Weeks 1, 3, 5

  9. Number of defects in preparation and vaccination during intradermal vaccination

    Measured: Week 1 through Week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2021
  2. Study start29 Jul 2021
  3. Primary completion10 Dec 2021
  4. Study completion23 Sep 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
422 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04993586
Sponsor's protocol ID
AG0302-COVID19-JN-03
Status last verified
Nov 2022
First submitted
30 Jul 2021
Last updated
9 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AG0302-COVID19 for Intramuscular Injection and AG0302-COVID19 for Intradermal Injection in people with COVID-19 Lower Respiratory Infection, run by AnGes, Inc. at 6 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 22 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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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. 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 (time frame: Week 1 through Week 13). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04993586.

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 9 Nov 2022.

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