COVID-19Phase 1/2NCT04863131
Safety and Immunogenicity of EXG-5003
A Phase 1/2 study testing EXG-5003 in people with COVID-19, run by Fujita Health University at 1 site in Japan.
Trial summary
This is a First in Human, randomized, placebo-controlled Phase I/II trial to evaluate the safety and immunogenicity of the intradermal COVID-19 vaccine, EXG-5003 in healthy adults. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- EXG-5003
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- 28 Apr 2021to 24 Jan 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has provided written consent for participation
- Age between 20 and 55
- Has a negative nucleic acid-based test result for SARS-CoV-2
- Has a negative antibody test result for SARS-CoV-2
Who cannot join
- Signs and symptoms consistent with COVID-19 upon screening
- History of COVID-19
- Presence of uncontrolled cardiovascular, hematologic, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disease
- Presence of diabetes mellitus
- Presence of active autoimmune disease
- Positive for HBc, HCV or HIV antibody
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- History of anaphylactic shock
- History of epilepsy
- Presence of active malignancy
- Presence of lung disease (e.g., COPD, asthma)
- Positive urine pregnancy test within 24 hours
- Pregnant, lactating, planned pregnancy of self (if female) or partner (if male) within 90 days after administration of the trial drug
- If female and premenopausal, not agreeable to contraception for 90 days after second administration of the trial drug
- If male, not agreeable to contraception for 90 days after second administration of the trial drug
- Presence of clinically relevant electrocardiogram or vital sign abnormality at screening
- Participated in a clinical trial of a drug or a medical device within 30 days or a biologic within 90 days
- Received any SARS-CoV-2 vaccine
- Received within 90 days, or is planning to receive during the study period, an immunoglobulin or blood product
- Received within 180 days, or is planning to receive during the study period, a biologic product with immunosuppressive properties
- Received for 14 days or more within 180 days, or is planning to receive during the study period, a corticosteroid
- Deemed ineligible for the study as determined by the principal investigator or a co-investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of Intradermal SARS-CoV-2 Vaccine EXG-5003 in Healthy Adults
This is a First in Human, randomized, placebo-controlled Phase I/II trial to evaluate the safety and immunogenicity of the intradermal COVID-19 vaccine, EXG-5003 in healthy adults.
- Conditions
- COVID-19
- Being tested
- EXG-5003, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXG-5003Biological
COVID-19 self-replicating mRNA vaccine
PlaceboBiological
placebo solution
| Study group | Role | What they receive |
|---|---|---|
| EXG-5003 | Experimental | Not described Receives: Biological: EXG-5003 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Local and Systemic Adverse Events
Measured: Day 1 up to Day 365 post dose
Secondary outcomes (4)
Flowcytometry assay to enumerate the frequency of T cells expressing CD3, CD4, CD8, CD62L, CD45RA, IFN-γ, IL-4, CD107, TNF, IL-2, IL-6, CD154 (CD40L), Perforin, and Granzyme B.
Measured: Day15, Day29, Day43, Day57, Day92, Day183, Day365
Assessment of T cells by Intracellular cytokine staining assays
Measured: Day15, Day29, Day57,
Genometric Mean Titer (GMT) of serum anti-RBD IgG
Measured: Day15, Day29, Day43, Day57, Day92, Day183, Day365
GMT of neutralizing antibody
Measured: Day15, Day29, Day43, Day57, Day92, Day183, Day365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start28 Apr 2021
- Primary completion31 Dec 2022
- Study completion24 Jan 2023
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujita Health University
- Sponsor type
- University, hospital or other
- Collaborators
- Elixirgen Therapeutics, Inc.
- Responsible party
- Principal investigator, Yohei Doi, Fujita Health University
- Investigators
- Yohei Doi, MD, Principal investigator, Fujita Health University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863131
- Sponsor's protocol ID
- EXG-5003-J01
- Status last verified
- Jan 2023
- First submitted
- 15 Apr 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Intradermal SARS-CoV-2 Vaccine EXG-5003 in Healthy Adults
- ClinicalTrials.gov ID
- NCT04863131
- Acronym / sponsor ID
- EXG-5003-J01
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fujita Health UniversityUniversity, hospital or other
- Collaborators
- Elixirgen Therapeutics, Inc.
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 28 Apr 2021 (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 is a First in Human, randomized, placebo-controlled Phase I/II trial to evaluate the safety and immunogenicity of the intradermal COVID-19 vaccine, EXG-5003 in healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXG-5003 | Experimental | Biological: EXG-5003 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Has provided written consent for participation
- Age between 20 and 55
- Has a negative nucleic acid-based test result for SARS-CoV-2
- Has a negative antibody test result for SARS-CoV-2
Key exclusion criteria (21 listed)
- Signs and symptoms consistent with COVID-19 upon screening
- History of COVID-19
- Presence of uncontrolled cardiovascular, hematologic, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disease
- Presence of diabetes mellitus
- Presence of active autoimmune disease
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 |
|---|---|---|
| EXG-5003COVID-19 self-replicating mRNA vaccine | Biological | EXG-5003 |
| Placeboplacebo solution | Biological | Placebo |
Primary outcome
Number of Participants Reporting Local and Systemic Adverse Events
Time frame: Day 1 up to Day 365 post dose
4 secondary outcomes
Flowcytometry assay to enumerate the frequency of T cells expressing CD3, CD4, CD8, CD62L, CD45RA, IFN-γ, IL-4, CD107, TNF, IL-2, IL-6, CD154 (CD40L), Perforin, and Granzyme B.
Time frame: Day15, Day29, Day43, Day57, Day92, Day183, Day365
Assessment of T cells by Intracellular cytokine staining assays
Time frame: Day15, Day29, Day57,
Genometric Mean Titer (GMT) of serum anti-RBD IgG
Time frame: Day15, Day29, Day43, Day57, Day92, Day183, Day365
GMT of neutralizing antibody
Time frame: Day15, Day29, Day43, Day57, Day92, Day183, Day365
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 26 Jan 2023.
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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.
Yohei Doi, MD principal investigator
Fujita Health University Hospital
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 EXG-5003 in people with COVID-19, run by Fujita Health University 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 21 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 26 Jan 2023. 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. 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 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?
Number of Participants Reporting Local and Systemic Adverse Events (time frame: Day 1 up to Day 365 post dose). 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 26 Jan 2023.