Covid19Phase 1NCT05047692
Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers
A Phase 1 study testing AdCLD-CoV19-1 in people with Covid19, run by Cellid Co., Ltd. at 3 sites in South Korea.
Trial summary
This is a Phase 1 clinical trial to assess the safety and immunogenicity of AdCLD-CoV19-1 in healthy adults. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- AdCLD-CoV19-1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 9 Sep 2021to 21 Jun 2023
- Phase
- Phase 1
- 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 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able and willing to agree informed consent and aged 19 to 64 years.
- The BMI index is 18.5 kg/m2 to 30.0 kg/m2.
- Able and willing to medically effective contraception during the whole study period.
- Agreement to refrain from blood donation during the whole study period.
Who cannot join
- Anyone deemed infected by COVID-19.
- Determined to be a close-contact of SARS-CoV-2 confirmed case or classified to symptomatic patient of COVID-19 prior to vaccination.
- Clinically significant abnormal ranges of laboratory measurement, ECG, Chest X-ray at screening visit.
- Positive in HIV, HBV, HCV test at screening visit.
- Acute fever(≥ 38℃) or suspected infectious disease, symptoms of infectious disease(cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste, etc.) within 3 days prior to vaccination.
- Chronic respiratory disease: Asthma, chronic obstructive pulmonary disease, active tuberculosis, latent tuberculosis under treatment.
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- Clinically significant active or any history of disease: Hepatobiliary system, kidney, central or peripheral nervous system (epilepsy, seizure, etc.), endocrine system (uncontrolled diabetes, hyperlipidemia, etc.), cardiovascular system (congestive heart failure, coronary artery disease, myocardial infarction, control Hypertension, etc.), blood tumor, urinary system, mental, musculoskeletal system, immune system (rheumatoid arthritis, systemic lupus erythematosus).
- Immunosuppressive disease including immunodeficiency disease.
- Scheduled to undergo any surgery during the whole study period.
- Healthcare worker who provide medical care to SARS-CoV-2 cases or occupationally in high risk for SARS-CoV-2 exposure during the whole study period.
- Prisoners or subjects who are compulsorily detained. (involuntary incarceration)
- History of SARS or MERS.
- Allergic reaction or hypersensitivity to any ingredient of AdCLD-CoV19-1.
- Having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants.
- Any history of malignant disease within the past 5 years. History of hypersensitivity to inoculate vaccine such as Guillain-Barre syndrome.
- History of serious adverse reaction or allergic reaction to inoculate vaccine.
- Urticaria past 5 years prior to vaccination.
- History of hereditary angioneurotic edema or acquired angioneurotic edema.
- History of solid organ or bone marrow transplantation.
- Suspected or a history of drug or alcohol abuse past 12 month before vaccination.
- Receipt of vaccine of SARS-CoV, MERS-CoV, SARS-CoV-2.
- Receipt of adenovirus vector based vaccine.
- Chronic use of immunosuppressant or immune modifying drug within 6 months prior to vaccination. (use of inhaled, topical, nasal, and ophthalmic corticosteroids are allowed)
- Having relied on antipsychotic drugs and narcotic analgesics within 6 months before vaccination or difficult to comply with the clinical trial procedure at the judgment of the investigator.
- Administered to other investigational product or medical device within 6 months before vaccination.
- Other vaccination history within 30 days prior to vaccination or being scheduled within 30 days after vaccination.
- Receipt of immunoglobulin or any blood product within 3 month prior to vaccination.
- Pregnant(including positive hCG test at screening visit) or breastfeeding female.
- Those who are directly related to the investigator.
- Other condition deemed ineligible for the study at the discretion of investigator.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Korea University Ansan Hospital
Ansan, Province
Korea University Guro Hospital
Seoul, State
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, Province
About this study
Official title: A Dose Escalation, Multicenter, Open, Phase I Study to Assess the Safety and Immunogenicity of AdCLD-CoV19-1, a COVID-19 Preventive Vaccine in Healthy Volunteers.
This is a Phase 1 clinical trial to assess the safety and immunogenicity of AdCLD-CoV19-1 in healthy adults.
Read the detailed description
This is a dose-escalation, multi-center, open-label, Phase 1 clinical trial. We assess the safety of AdCLD-CoV19-1 and immune responses against SARS-CoV-2. DSMB will evaluate safety when events occurred during the whole study period.
- Conditions
- Covid19
- Being tested
- AdCLD-CoV19-1
- Keywords
- COVID-19, Prevention, Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdCLD-CoV19-1Biological
Replication deficient adenoviral vector based COVID-19 prevention vaccine containing recombinant gene of SARS-CoV-2 spike protein
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Low dose | Experimental | The subject will receive a single dose of AdCLD-CoV19-1(5.0x10^10VP) as an intramuscular injection. Receives: Biological: AdCLD-CoV19-1 |
| Group 2: High dose | Experimental | The subject will receive a single dose of AdCLD-CoV19-1(1.0x10^11VP) as an intramuscular injection. Receives: Biological: AdCLD-CoV19-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of solicited adverse events(AEs)
Measured: Through 7 days post-vaccination
Incidence of unsolicited AEs
Measured: Through 28 days post-vaccination
Secondary outcomes (6)
Incidence of serious adverse events(SAEs)
Measured: Through 12 months post-vaccination
Incidence of adverse events of special interest(AESIs)
Measured: Through 12 months post-vaccination
Seroconversion rate(SCR) of neutralization antibody against wild type SARS-CoV-2
Measured: 4 weeks post-vaccination
Geometric mean titer(GMT) of neutralization antibody against wild type SARS-CoV-2
Measured: 4 weeks post-vaccination
GMT of S protein specific antibody
Measured: 2, 4, 26, 52 weeks post-vaccination
S protein specific T cell response
Measured: 2, 4, 26, 52 weeks post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start9 Sep 2021
- Primary completion2 Dec 2022
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellid Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047692
- Sponsor's protocol ID
- AdCLD-CoV19-1-001
- Status last verified
- Jul 2023
- First submitted
- 14 Sep 2021
- Last updated
- 28 Jul 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 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation, Multicenter, Open, Phase I Study to Assess the Safety and Immunogenicity of AdCLD-CoV19-1, a COVID-19 Preventive Vaccine in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT05047692
- Acronym / sponsor ID
- AdCLD-CoV19-1-001
- Conditions
- Covid19
- Keywords
- COVID-19, Prevention, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cellid Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 17 Sep 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 Phase 1 clinical trial to assess the safety and immunogenicity of AdCLD-CoV19-1 in healthy adults.
Detailed description
This is a dose-escalation, multi-center, open-label, Phase 1 clinical trial. We assess the safety of AdCLD-CoV19-1 and immune responses against SARS-CoV-2. DSMB will evaluate safety when events occurred during the whole study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Low dose | Experimental | Biological: AdCLD-CoV19-1The subject will receive a single dose of AdCLD-CoV19-1(5.0x10^10VP) as an intramuscular injection. |
| Group 2: High dose | Experimental | Biological: AdCLD-CoV19-1The subject will receive a single dose of AdCLD-CoV19-1(1.0x10^11VP) as an intramuscular injection. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able and willing to agree informed consent and aged 19 to 64 years.
- The BMI index is 18.5 kg/m2 to 30.0 kg/m2.
- Able and willing to medically effective contraception during the whole study period.
- Agreement to refrain from blood donation during the whole study period.
Key exclusion criteria (30 listed)
- Anyone deemed infected by COVID-19.
- Determined to be a close-contact of SARS-CoV-2 confirmed case or classified to symptomatic patient of COVID-19 prior to vaccination.
- Clinically significant abnormal ranges of laboratory measurement, ECG, Chest X-ray at screening visit.
- Positive in HIV, HBV, HCV test at screening visit.
- Acute fever(≥ 38℃) or suspected infectious disease, symptoms of infectious disease(cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste, etc.) within 3 days prior to vaccination.
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 |
|---|---|---|
| AdCLD-CoV19-1Replication deficient adenoviral vector based COVID-19 prevention vaccine containing recombinant gene of SARS-CoV-2 spike protein | Biological | Group 1: Low dose, Group 2: High dose |
Primary outcome
Incidence of solicited adverse events(AEs)
Time frame: Through 7 days post-vaccination
Incidence of unsolicited AEs
Time frame: Through 28 days post-vaccination
6 secondary outcomes
Incidence of serious adverse events(SAEs)
Time frame: Through 12 months post-vaccination
Incidence of adverse events of special interest(AESIs)
Time frame: Through 12 months post-vaccination
Seroconversion rate(SCR) of neutralization antibody against wild type SARS-CoV-2
Time frame: 4 weeks post-vaccination
Geometric mean titer(GMT) of neutralization antibody against wild type SARS-CoV-2
Time frame: 4 weeks post-vaccination
GMT of S protein specific antibody
Time frame: 2, 4, 26, 52 weeks post-vaccination
S protein specific T cell response
Time frame: 2, 4, 26, 52 weeks post-vaccination
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 28 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AdCLD-CoV19-1 in people with Covid19, run by Cellid Co., Ltd. at 3 sites in South Korea.
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 30 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 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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 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.
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 solicited adverse events(AEs) (time frame: Through 7 days post-vaccination). 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 28 Jul 2023.