Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers

July 27, 2023 updated by: Cellid Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Province
      • Ansan, Province, Korea, Republic of
        • Korea University Ansan Hospital
      • Suwon, Province, Korea, Republic of
        • The Catholic University of Korea, St. Vincent's Hospital
    • State
      • Seoul, State, Korea, Republic of
        • Korea University Guro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1: Low dose
The subject will receive a single dose of AdCLD-CoV19-1(5.0x10^10VP) as an intramuscular injection.
Biological: AdCLD-CoV19-1
Replication deficient adenoviral vector based COVID-19 prevention vaccine containing recombinant gene of SARS-CoV-2 spike protein
Experimental: Group 2: High dose
The subject will receive a single dose of AdCLD-CoV19-1(1.0x10^11VP) as an intramuscular injection.
Biological: AdCLD-CoV19-1
Replication deficient adenoviral vector based COVID-19 prevention vaccine containing recombinant gene of SARS-CoV-2 spike protein

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of solicited adverse events(AEs)
Time Frame: Through 7 days post-vaccination
Through 7 days post-vaccination
Incidence of unsolicited AEs
Time Frame: Through 28 days post-vaccination
Through 28 days post-vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of serious adverse events(SAEs)
Time Frame: Through 12 months post-vaccination
Through 12 months post-vaccination
Incidence of adverse events of special interest(AESIs)
Time Frame: Through 12 months post-vaccination
Through 12 months post-vaccination
Seroconversion rate(SCR) of neutralization antibody against wild type SARS-CoV-2
Time Frame: 4 weeks post-vaccination
4 weeks post-vaccination
Geometric mean titer(GMT) of neutralization antibody against wild type SARS-CoV-2
Time Frame: 4 weeks post-vaccination
4 weeks post-vaccination
GMT of S protein specific antibody
Time Frame: 2, 4, 26, 52 weeks post-vaccination
2, 4, 26, 52 weeks post-vaccination
S protein specific T cell response
Time Frame: 2, 4, 26, 52 weeks post-vaccination
2, 4, 26, 52 weeks post-vaccination

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
GMT of S protein receptor binding domain(RBD) specific antibody
Time Frame: 2, 4, 26, 52 weeks post-vaccination
2, 4, 26, 52 weeks post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cellid Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AdCLD-CoV19-1-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on AdCLD-CoV19-1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings