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COVID-19Phase 1/2NCT04666012

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

A Phase 1/2 study testing AdCLD-CoV19 in people with COVID-19, run by Cellid Co., Ltd. at 5 sites in South Korea.

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 is a Phase 1/2a clinical trial to assess the safety and immunogenicity of AdCLD-CoV19 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
COVID-19
What is being tested?
AdCLD-CoV19
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
5 sitesSouth Korea
Study dates
29 Dec 2020to 27 Mar 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 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.
  • Weigh 40kg to 100kg (Part A only)
  • 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.
  • 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.
  • Current smoker or vaper. (use of cigarette or e-cigarette at least once in last 30 days, Part A only)
  • Those who are directly related to the investigator.
  • Other condition deemed ineligible for the study at the discretion of investigator.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

South Korea5 sites

  • Korea University Ansan Hospital

    Ansan, Province

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, State

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul, State

  • Korea University Guro Hospital

    Seoul

  • The Catholic University of Korea, ST. Vincent's Hospital

    Suwon, Province

Other trials in South Korea

About this study

Official title: A Phase 1/2a Study (Dose Escalation, Single Center, Open, Phase 1 and Multicenter, Open, Phase 2a) to Assess the Safety and Immunogenicity of AdCLD-CoV19: A COVID-19 Preventive Vaccine in Healthy Volunteers

This is a Phase 1/2a clinical trial to assess the safety and immunogenicity of AdCLD-CoV19 in healthy adults.

Read the detailed description

Part A is conducted as dose-escalation, single-center, open-label, a Phase 1 clinical trial. Part B is conducted as multi-center, open-label, a Phase 2a clinical trial. In Part A, we assess safety in all dose groups and set suitable two doses for Part B. In Part B, we assess immune responses against SARS-CoV-2 and set suitable dose for next phase of clinical trial. DSMB will evaluate safety during the whole study period.

Conditions
COVID-19
Being tested
AdCLD-CoV19
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-CoV19Biological

    Replication-defective human adenovirus type 5/35 vector based vaccine expressing S protein of SARS-CoV-2.

Study groups in NCT04666012
Study groupRoleWhat they receive
Group 1: low doseExperimentalSubject will receive single dose of AdCLD-CoV19(2.5x10^10VP) as intramuscular injection.
Receives: Biological: AdCLD-CoV19
Group 2: middle doseExperimentalSubject will receive single dose of AdCLD-CoV19(5.0x10^10VP) as intramuscular injection.
Receives: Biological: AdCLD-CoV19
Group 3: high doseExperimentalSubject will receive single dose of AdCLD-CoV19(1.0x10^11VP) as intramuscular injection.
Receives: Biological: AdCLD-CoV19
Group 4: selected doseExperimentalSubject will receive single dose of AdCLD-CoV19 as intramuscular injection.
Receives: Biological: AdCLD-CoV19
Group 5: selected doseExperimentalSubject will receive single dose of AdCLD-CoV19 as intramuscular injection.
Receives: Biological: AdCLD-CoV19

What is being measured

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

  1. Incidence of solicited adverse events(AEs)

    Measured: Through 7 days post-vaccination

  2. Incidence of unsolicited AEs

    Measured: Through 28, 56 days post-vaccination

Secondary outcomes (6)

  1. Incidence of serious adverse events(SAEs)

    Measured: Through 12 months post-vaccination

  2. Incidence of adverse events of special interest(AESIs)

    Measured: Through 12 months post-vaccination

  3. Seroconversion rate(SCR) of neutralization antibody using wild type SARS-CoV-2

    Measured: 4, 8 weeks post-vaccination

  4. Geometric mean titer(GMT) of neutralization antibody using wild type SARS-CoV-2

    Measured: 4, 8 weeks post-vaccination

  5. GMT of S protein specific antibody

    Measured: 2, 4, 8, 26, 52 weeks post-vaccination

  6. Index of 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.

  1. First posted14 Dec 2020
  2. Study start29 Dec 2020
  3. Primary completion9 Jul 2021
  4. Study completion27 Mar 2023

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04666012
Sponsor's protocol ID
AdCLD-CoV19-001
Status last verified
Jul 2023
First submitted
10 Dec 2020
Last updated
28 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AdCLD-CoV19 in people with COVID-19, run by Cellid Co., Ltd. at 5 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 5 inclusion and 32 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 5 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 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 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?

On the ClinicalTrials.gov record for NCT04666012.

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.

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Clinical Trial NCT04666012 | AzTrials