COVID-19Phase 1/2NCT05576623
Safety and Immunogenicity of AdCLD-CoV19-1 OMI as a Booster: A SARS-CoV-2 (COVID-19) Preventive Vaccine
A Phase 1/2 study testing AdCLD-CoV19-1 OMI (Part A) and AdCLD-CoV19-1 OMI (Part B) in people with COVID-19 and Vaccines, run by Cellid Co., Ltd. at 7 sites in South Korea.
Trial summary
The safety and immunogenicity of AdCLD-CoV19-1 OMI (5.0x10^10 VP (0.5 mL)/dose/Vial) administered as a booster in healthy adults aged 19 years old and above will be evaluated. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- What is being tested?
- AdCLD-CoV19-1 OMI (Part A) and AdCLD-CoV19-1 OMI (Part B)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 14 Sep 2022to 28 Feb 2024
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (Part A) Individual aged between 19-64 years old and willing to provide written informed consent to participate study voluntarily.
- (Part B) Individual aged 19 years and above and willing to provide written informed consent to participate study voluntarily.
- Individual fall under one or more of the following;
- Those who have been at least 16 weeks (112 days) and less than 48 weeks (336 days) without additional COVID-19 vaccination since the last COVID-19 vaccination.
- Those who have been at least 16 weeks (112 days) or more and less than 48 weeks (336 days) since the release of quarantine due to COVID-19 confirmation.
- Individual with body mass index (BMI) of 30.0 kg/m2 or less at screening visit.
- Individual who agrees with using an effective birth control method for at least 4 weeks before the screening and during the study period.
- Individual who agrees not to donate or transfuse blood (including whole blood, plasma components, platelet components, and platelet plasma components) during the study period.
Who cannot join
- Individual who has history of COVID-19 or is considered infected within 16 weeks (112 days) prior to administration of investigational product.
- Individual who has received other COVID-19 vaccine within 16 weeks (112 days) prior to administration of investigational product.
- Individual who has been in close contact with a COVID-19 infected person, or has been classified as a confirmed or suspected COVID-19 patient within 14 days prior to administration of investigational product.
- Individual determined to be clinically significantly abnormal by the screening outcome based on laboratory evaluations, electrocardiogram (ECG) and Chest X-ray.
- Individual who has ant results of positive to HIV test, hepatitis B test, and hepatitis C test on screening.
- Acute febrile illness with 38°C and above, or any suspected infectious diseases, or symptoms similar to COVID-19 (cough, shortness of breathe, chills, myalgia, headache, sore throat, loss of taste/smell, etc.) within 3 days prior to administration of investigational product.
Show all 39Show fewer
- Any serious medical or psychiatric disease which in opinion of investigator judges unable to participate
- Respiratory diseases: Asthma, Chronic Obstructive Lung Disease (COPD), active or latent tuberculosis which require medication, or individual who has received treatment due to worsening of the respiratory disease within 5 years prior to administration of investigational product.
- Serious cardiovascular diseases: Congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension, myocarditis, pericarditis, etc.
- Neurologic diseases: Epilepsy, seizure within 3 years, migraine, stroke, encephalopathy, Guillain-Barre Syndrome, encephalomyelitis, acute transverse myelitis, etc.
- Malignant cancer diagnosed within the past 5 years (skin basal cell and squamous cell carcinoma are excluded).
- Immune function disorders including autoimmune hypothyroidism, psoriasis.
- Auto-immune diseases.
- History of dependently administering psychotropic drugs or narcotic painkillers within 24 weeks prior to administration of investigational product, or psychiatric disease or behavioral impairment that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial.
- Other hepatobiliary, renal, endocrine, urinary tract, muscular skeletal diseases which the investigator considers clinically significant.
- History of splenectomy.
- History of SARS-CoV or MERS-CoV infection.
- Known history of allergic or hypersensitivity to the components of investigational product.
- Known history of serious adverse reactions, allergies or hypersensitivity related to vaccination.
- History of urticaria within 5 years prior to administration of investigational product.
- Individual with history of bleeding diathesis or thrombocytopenia, or history of severe bleeding or bruising after intramuscular or intravenous injection, or is receiving an anticoagulant (Those who receive low dose aspirin (less than 100mg/day) are not excluded).
- Individual with hereditary or idiopathic angioneurotic edema.
- Individual with solid organ or bone marrow transplantation.
- Individual who is suspected or with history of substance abuse and alcohol abuse within 24 weeks prior to administration of investigational product.
- History of SARS-CoV or MERS-CoV vaccination.
- History of licensed drug for COVID-19 treatment or prevention aside from COVID-19 vaccine within 52 weeks prior to administration of investigational product.
- Use of immunosuppressive or chronic use of systemic steroids within 6 weeks prior to administration of investigational product (External steroids, nasal spray and inhalants are allowed).
- Immunosuppressive: Azathioprine, Cyclosporine, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, Cyclophosphamide, 6-Mercaptopurine, Methotrexate, Rapamycin, Leflunomide, etc.
- Chronic steroid: >10 mg/day prednisone equivalent for periods exceeding 14 days)
- Individuals who has administered other investigational product or device within 24 weeks prior to screening visit.
- Individual concomitantly enrolled or scheduled to be enrolled in another trial (including follow-up period).
- Individual vaccinated or planned vaccination within 28 days prior and after the administration of investigational product.
- Receipt of immunoglobulin or blood-derived products within 12 weeks prior to administration of investigational product.
- Individual with scheduled surgery during the study period.
- Pregnant or lactating women.
- Individual directly related to the investigator and meets the following conditions:
- Personnel relationship or subordinate-superior relationship (employees of the investigator's department, staffs of this trial)
- Students or researchers in the immediate department of the school to which the investigator belongs (e.g., medical university)
- Individual who is unfit for this study for any other reason in judgement of investigator.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do
Korea University Ansan Hospital
Gyeonggi-do
The Catholic University of Korea ST. Vincent's Hospital
Gyeonggi-do
Gachon University Gil Medical Center
Incheon
Inha University Hospital
Incheon
Hallym University Kangnam Sacred Heart Hospital
Seoul
Korea University Guro Hospital
Seoul
About this study
Official title: A Phase I/II (Single Center, Open, Phase I and Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Phase II) Trial to Evaluate the Safety and Immunogenicity of the AdCLD-CoV19-1 OMI Administered as a Booster to Healthy Adults Aged 19 Years Old and Above
The safety and immunogenicity of AdCLD-CoV19-1 OMI (5.0x10^10 VP (0.5 mL)/dose/Vial) administered as a booster in healthy adults aged 19 years old and above will be evaluated.
- Being tested
- AdCLD-CoV19-1 OMI (Part A), AdCLD-CoV19-1 OMI (Part B), Placebo (Part B)
- Keywords
- COVID-19, SARS-CoV-2, Omicron, B.1.1.529
- 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-CoV19-1 OMI (Part A)Biological
20 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular injection in the deltoid muscle
AdCLD-CoV19-1 OMI (Part B)Biological
250 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular injection in the deltoid muscle
Placebo (Part B)Other
50 participants will receive placebo via intramuscular injection in the deltoid muscle
| Study group | Role | What they receive |
|---|---|---|
| 1 dose of AdCLD-CoV19-1 OMI (Part A) | Experimental | Group in Part A will receive 1 dose of AdCLD-CoV19-1 OMI Receives: Biological: AdCLD-CoV19-1 OMI (Part A) |
| 1 dose of AdCLD-CoV19-1 OMI (Part B) | Experimental | Group 1 in Part B will receive 1 dose of AdCLD-CoV19-1 OMI Receives: Biological: AdCLD-CoV19-1 OMI (Part B) |
| Placebo (Part B) | Placebo comparator | Group 2 in Part B will receive 1 dose of placebo Receives: Other: Placebo (Part B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of immediate adverse events (AE)
Proportion of immediate AE within 30 minutes post dose injection.
Measured: Within 30 minutes post dose injection
Proportion of solicited local and systemic AE
Proportion of solicited local and systemic AEs within 7 days post dose injection. Local AEs at the site of injection: Pain, tenderness, erythema/redness, swelling/induration, pruritis. Systemic AEs: Fever, fatigue/general weakness, chill, headache, myalgia, arthralgia, diarrhea, nausea/vomiting, abdominal pain, mucocutaneous reaction/rash, urticaria, dizziness, cough, dyspnea.
Measured: Within 7 days (Days 0 - 6) post dose injection
Proportion of unsolicited AE
Proportion of unsolicited AEs within 28 days post dose injection. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited AEs).
Measured: Within 28 days post dose injection
Proportion of SAE
Proportion of any SAE from the administration throughout the entire study. An AE or suspected adverse reaction is considered "serious": Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above.
Measured: Throughout the study duration, 12 months post dose injection
Proportion of Adverse Event Of Special Interest (AESI)
Proportion of any AESI from the administration throughout the entire study. AESI are categorized into 1) AESIs included because they are seen with COVID-19 Disease, 2) AESI included because they have a proven or theoretical association with immunization in general, 3) AESI included because they have a proven or theoretical association with specific vaccine platform(s).
Measured: Throughout the study duration, 12 months post dose injection
Proportion of Medically-Attended Adverse Events (MAAE)
Proportion of any MAAE from the administration throughout the entire study. Medically-attended AEs are AEs with medically-attended visits including hospital, emergency room, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically attended visits.
Measured: Throughout the study duration, 12 months post dose injection
Proportion of clinically significant changes in clinical safety laboratory parameters
Proportion of clinically significant changes in clinical safety laboratory parameters at 7, 14, 28 days post dose injection.
Measured: At 7, 14, 28 days post dose injection
Proportion of participants achieving seroresponse of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody)
Proportion of participants achieving seroresponse (SR defined as at least 2-fold increase from baseline) of wild-type virus neutralizing antibody titer from baseline to 2, 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
Measured: At 2, 4 weeks post dose injection
Geometric Mean Titer of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody)
Geometric Mean Titer (GMT) of neutralizing antibody to the SARS-CoV-2 B.1.1.529 measured by wild-type virus neutralization assay from baseline to 2, 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
Measured: At 2, 4 weeks post dose injection
Geometric Mean Fold Rise of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody)
Geometric Mean Fold Rise (GMFR) of neutralizing antibody to the SARS-CoV-2 B.1.1.529 measured by wild-type virus neutralization assay from baseline to 2, 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
Measured: At 2, 4 weeks post dose injection
Secondary outcomes (8)
Proportion of participants achieving seroresponse of 1 dose of AdCLD-CoV19-1 OMI from baseline to 12, 26, 52 weeks post dose injection (Neutralizing antibody)
Proportion of participants achieving seroresponse (SR defined as at least 2-fold increase from baseline) of wild-type virus neutralizing antibody titer from baseline to 12, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
Measured: At 12, 26, 52 weeks post dose injection
Geometric Mean Titer of 1 dose of AdCLD-CoV19-1 OMI from baseline to 12, 26, 52 weeks post dose injection (Neutralizing antibody)
Geometric Mean Titer (GMT) of neutralizing antibody to the SARS-CoV-2 B.1.1.529 measured by wild-type virus neutralization assay from baseline to 12, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
Measured: At 12, 26, 52 weeks post dose injection
Geometric Mean Fold Rise of 1 dose of AdCLD-CoV19-1 OMI from baseline to 12, 26, 52 weeks post dose injection (Neutralizing antibody)
Geometric Mean Fold Rise (GMFR) of neutralizing antibody to the SARS-CoV-2 B.1.1.529 measured by wild-type virus neutralization assay from baseline to 12, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
Measured: At 12, 26, 52 weeks post dose injection
Proportion of participants achieving seroresponse of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4, 12, 26, 52 weeks post dose injection (ELISA)
Proportion of participants achieving seroresponse (SR defined as at least 2-fold increase from baseline) of SARS-CoV-2 B.1.1.529 Spike-binding ELISA IgG antibody from baseline to 2, 4, 12, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
Measured: At 2, 4, 12, 26, 52 weeks post dose injection
GMT of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4, 12, 26, 52 weeks post dose injection (ELISA)
GMT of SARS-CoV-2 B.1.1.529 Spike-binding ELISA IgG antibody from baseline to 2, 4, 12, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
Measured: At 2, 4, 12, 26, 52 weeks post dose injection
GMFR of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4, 12, 26, 52 weeks post dose injection (ELISA)
GMFR of SARS-CoV-2 B.1.1.529 Spike-binding ELISA IgG antibody from baseline to 2, 4, 12, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
Measured: At 2, 4, 12, 26, 52 weeks post dose injection
Cell Mediated Immunity (CMI) of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 26, 52 weeks post dose injection (Proportion of responders by Interferon-γ (IFN-γ) ELISpot)
Proportion of responders as measured by Interferon-γ (IFN-γ) ELISpot from baseline to 2, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
Measured: At 2, 26, 52 weeks post dose injection
Cell Mediated Immunity (CMI) of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 26, 52 weeks post dose injection (Median spot forming units by Interferon-γ (IFN-γ) ELISpot)
Median spot forming units as measured by Interferon-γ (IFN-γ) ELISpot from baseline to 2, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
Measured: At 2, 26, 52 weeks post dose injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start14 Sep 2022
- Primary completion10 Mar 2023
- Study completion28 Feb 2024
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
- 320 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
- NCT05576623
- Sponsor's protocol ID
- COVENT-201
- Status last verified
- Jul 2024
- First submitted
- 10 Oct 2022
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II (Single Center, Open, Phase I and Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Phase II) Trial to Evaluate the Safety and Immunogenicity of the AdCLD-CoV19-1 OMI Administered as a Booster to Healthy Adults Aged 19 Years Old and Above
- ClinicalTrials.gov ID
- NCT05576623
- Acronym / sponsor ID
- COVENT-201
- Keywords
- COVID-19, SARS-CoV-2, Omicron, B.1.1.529
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Cellid Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 12 Oct 2022 (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.
The safety and immunogenicity of AdCLD-CoV19-1 OMI (5.0x10^10 VP (0.5 mL)/dose/Vial) administered as a booster in healthy adults aged 19 years old and above will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 dose of AdCLD-CoV19-1 OMI (Part A) | Experimental | Biological: AdCLD-CoV19-1 OMI (Part A)Group in Part A will receive 1 dose of AdCLD-CoV19-1 OMI |
| 1 dose of AdCLD-CoV19-1 OMI (Part B) | Experimental | Biological: AdCLD-CoV19-1 OMI (Part B)Group 1 in Part B will receive 1 dose of AdCLD-CoV19-1 OMI |
| Placebo (Part B) | Placebo comparator | Other: Placebo (Part B)Group 2 in Part B will receive 1 dose of placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- (Part A) Individual aged between 19-64 years old and willing to provide written informed consent to participate study voluntarily.
- (Part B) Individual aged 19 years and above and willing to provide written informed consent to participate study voluntarily.
- Individual fall under one or more of the following;
- Individual with body mass index (BMI) of 30.0 kg/m2 or less at screening visit.
- Individual who agrees with using an effective birth control method for at least 4 weeks before the screening and during the study period.
Key exclusion criteria (39 listed)
- Individual who has history of COVID-19 or is considered infected within 16 weeks (112 days) prior to administration of investigational product.
- Individual who has received other COVID-19 vaccine within 16 weeks (112 days) prior to administration of investigational product.
- Individual who has been in close contact with a COVID-19 infected person, or has been classified as a confirmed or suspected COVID-19 patient within 14 days prior to administration of investigational product.
- Individual determined to be clinically significantly abnormal by the screening outcome based on laboratory evaluations, electrocardiogram (ECG) and Chest X-ray.
- Individual who has ant results of positive to HIV test, hepatitis B test, and hepatitis C test on screening.
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-CoV19-1 OMI (Part A)20 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular injection in the deltoid muscle | Biological | 1 dose of AdCLD-CoV19-1 OMI (Part A) |
| AdCLD-CoV19-1 OMI (Part B)250 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular injection in the deltoid muscle | Biological | 1 dose of AdCLD-CoV19-1 OMI (Part B) |
| Placebo (Part B)50 participants will receive placebo via intramuscular injection in the deltoid muscle | Other | Placebo (Part B) |
Primary outcome
Proportion of immediate adverse events (AE)
Time frame: Within 30 minutes post dose injection
Proportion of immediate AE within 30 minutes post dose injection.
Proportion of solicited local and systemic AE
Time frame: Within 7 days (Days 0 - 6) post dose injection
Proportion of solicited local and systemic AEs within 7 days post dose injection. Local AEs at the site of injection: Pain, tenderness, erythema/redness, swelling/induration, pruritis. Systemic AEs: Fever, fatigue/general weakness, chill, headache, myalgia, arthralgia, diarrhea, nausea/vomiting, abdominal pain, mucocutaneous reaction/rash, urticaria, dizziness, cough, dyspnea.
Proportion of unsolicited AE
Time frame: Within 28 days post dose injection
Proportion of unsolicited AEs within 28 days post dose injection. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited AEs).
Proportion of SAE
Time frame: Throughout the study duration, 12 months post dose injection
Proportion of any SAE from the administration throughout the entire study. An AE or suspected adverse reaction is considered "serious": Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above.
Proportion of Adverse Event Of Special Interest (AESI)
Time frame: Throughout the study duration, 12 months post dose injection
Proportion of any AESI from the administration throughout the entire study. AESI are categorized into 1) AESIs included because they are seen with COVID-19 Disease, 2) AESI included because they have a proven or theoretical association with immunization in general, 3) AESI included because they have a proven or theoretical association with specific vaccine platform(s).
Proportion of Medically-Attended Adverse Events (MAAE)
Time frame: Throughout the study duration, 12 months post dose injection
Proportion of any MAAE from the administration throughout the entire study. Medically-attended AEs are AEs with medically-attended visits including hospital, emergency room, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically attended visits.
Proportion of clinically significant changes in clinical safety laboratory parameters
Time frame: At 7, 14, 28 days post dose injection
Proportion of clinically significant changes in clinical safety laboratory parameters at 7, 14, 28 days post dose injection.
Proportion of participants achieving seroresponse of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody)
Time frame: At 2, 4 weeks post dose injection
Proportion of participants achieving seroresponse (SR defined as at least 2-fold increase from baseline) of wild-type virus neutralizing antibody titer from baseline to 2, 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
Geometric Mean Titer of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody)
Time frame: At 2, 4 weeks post dose injection
Geometric Mean Titer (GMT) of neutralizing antibody to the SARS-CoV-2 B.1.1.529 measured by wild-type virus neutralization assay from baseline to 2, 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
Geometric Mean Fold Rise of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody)
Time frame: At 2, 4 weeks post dose injection
Geometric Mean Fold Rise (GMFR) of neutralizing antibody to the SARS-CoV-2 B.1.1.529 measured by wild-type virus neutralization assay from baseline to 2, 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.
8 secondary outcomes
Proportion of participants achieving seroresponse of 1 dose of AdCLD-CoV19-1 OMI from baseline to 12, 26, 52 weeks post dose injection (Neutralizing antibody)
Time frame: At 12, 26, 52 weeks post dose injection
Geometric Mean Titer of 1 dose of AdCLD-CoV19-1 OMI from baseline to 12, 26, 52 weeks post dose injection (Neutralizing antibody)
Time frame: At 12, 26, 52 weeks post dose injection
Geometric Mean Fold Rise of 1 dose of AdCLD-CoV19-1 OMI from baseline to 12, 26, 52 weeks post dose injection (Neutralizing antibody)
Time frame: At 12, 26, 52 weeks post dose injection
Proportion of participants achieving seroresponse of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4, 12, 26, 52 weeks post dose injection (ELISA)
Time frame: At 2, 4, 12, 26, 52 weeks post dose injection
GMT of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4, 12, 26, 52 weeks post dose injection (ELISA)
Time frame: At 2, 4, 12, 26, 52 weeks post dose injection
GMFR of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4, 12, 26, 52 weeks post dose injection (ELISA)
Time frame: At 2, 4, 12, 26, 52 weeks post dose injection
Cell Mediated Immunity (CMI) of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 26, 52 weeks post dose injection (Proportion of responders by Interferon-γ (IFN-γ) ELISpot)
Time frame: At 2, 26, 52 weeks post dose injection
Cell Mediated Immunity (CMI) of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 26, 52 weeks post dose injection (Median spot forming units by Interferon-γ (IFN-γ) ELISpot)
Time frame: At 2, 26, 52 weeks post dose injection
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 17 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
7 sites 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 AdCLD-CoV19-1 OMI (Part A) and AdCLD-CoV19-1 OMI (Part B) in people with COVID-19 and Vaccines, run by Cellid Co., Ltd. at 7 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 8 inclusion and 39 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 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
Proportion of immediate adverse events (AE) (time frame: Within 30 minutes post dose injection). The study lists 10 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 17 Jul 2024.