Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID in Healthy Adult Volunteers

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    120
  • sponsor
    EyeGene Inc.
Updated on 4 October 2022
Accepts healthy volunteers

Summary

This is Phase 1 and 2a, Multi-center, Open-label study designed to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID vaccine in Healthy Adult Volunteers

Description

Subjects will undergo a Screening period beginning up to 14 days prior to enrollment, the vaccination(s) will be administered on Day 0, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable).

Subjects will be enrolled prior to vaccination on Day 0, to one (1) of two (2) treatment groups.

Details
Condition COVID-19 Vaccine
Treatment EG-COVID-003, EG-COVID-001
Clinical Study IdentifierNCT05188469
SponsorEyeGene Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure
Healthy volunteers aged above 18 years at time of screening
Have received last COVID-19 vaccination more than 3 months ago (more than 90 days) [Only Step 1]
Participants must have a body mass index (BMI) between ≥18.5 and ≤30.0 kg/m2 at screening
Availability to volunteer for the entire study duration and be willing to adhere to all protocol requirements
Must have a negative urine pregnancy test on the day of dosing prior to each vaccination
Must agree not to donate blood or receive transfusion (including whole blood, plasma, and platelet components)
Must agree to use highly effective, medically accepted double-barrier contraception (both male and female partners) from screening until study completion (until 3 months after second vaccination) as specified below in this criterion
Highly effective double-barrier contraception is defined as use of a condom AND one of the
following
Birth control pills (The Pill)
Depot or injectable birth control
IUD (Intrauterine Device)
Birth Control Patch (e.g., Ortho Evra)
NuvaRing®
Implantable contraception (e.g., Implanon)
Documented evidence of surgical sterilisation at least 6 months prior to screening
i.e., tubal ligation for female or vasectomy for male Rhythm methods are not
considered as highly effective methods of birth control. Female participants and
female partners of male participants must use contraception from the time of informed
consent and for 90 days after last vaccination of study drug
Female not of childbearing potential must be postmenopausal for ≥12 months. Postmenopausal
status will be confirmed through testing of follicle stimulating hormone (FSH) levels ≥ 40
IU/mL at screening for amenorrhoeic female participants
Male participants must refrain from sperm donation from start of study and for 90 days
after the last vaccination of study drug
Female participants who has had hysterectomy at least 6 months prior to screening must
provide documented evidence of surgical sterilisation and are not required to use double
barrier contraception where this is the usual and preferred lifestyle
Participants who are in same-sex relationships are not required to use contraception
Abstinence is acceptable where this is the usual and preferred lifestyle

Exclusion Criteria

Participant with the evidence of COVID-19 infection because of one or more of the
following
Positive for COVID-19 when performing RT-PCR with upper respiratory tract
samples; (oropharyngeal/nasopharyngeal swab), (However, if symptoms of cough or
sputum are present, additional RT-PCR is performed using a lower respiratory
tract sample (sputum), and registration is possible if all are negative)
History of COVID-19
Close contact with a person infected with COVID-19 or have been classified as
symptomatic person to COVID-19 within 14 days prior to the first vaccination
Symptomatic person
According to the doctor's opinion, COVID-19 is suspected as a clinical symptom
History of travel outside of the country and have clinical symptoms of COVID-19
within 14 days of return
Healthcare workers who can participate in the treatment of COVID-19 patients, or those
at high risk of exposure to SARS-CoV-2 (screening clinics and emergency room workers
workers related to COVID-19 prevention, workers involved in collecting or analysing
COVID-19 samples, etc.)
Clinically significant abnormalities in laboratory tests, electrocardiogram (ECG), or
chest X-rays performed at the screening
Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HbsAg)
human immunodeficiency virus (HIV) antibody, or Syphilis antibody at Screening
Is acutely febrile or ill 72 hours prior to the first vaccination
Fever is defined as a body temperature ≥38.0°Celsius / ≥100.4°Farenheit
Illness is defined as symptoms due to other infectious diseases (Cough, shortness
of breath, chills, muscle pain, headache, sore throat, loss of smell, or loss of
taste, etc.)
History of a diagnosis or condition that, in the judgment of the Investigator, may
affect study endpoint assessment or participant safety, specifically
Respiratory system: asthma, chronic obstructive pulmonary disease (COPD), daily
medication administration for active tuberculosis or latent tuberculosis
received treatment due to worsening of respiratory diseases within 5 years prior
to the first vaccination
Serious cardiovascular disease: Congestive heart failure, coronary artery
disease, myocardial infarction, uncontrolled hypertension, myocarditis
pericarditis, etc
Nervous system: Epilepsy, seizure (Within 3 years before the first vaccination)
migraine, stroke, encephalopathy, Guillain-Barré syndrome, encephalomyelitis
transverse myelitis, etc
Diagnosis of malignancy within the previous 10 years before the first vaccination
(except basal cell and squamous cell carcinoma)
Autoimmune diseases, including autoimmune hypothyroidism or psoriasis
Immunodeficiency disease
Hepatobiliary, renal, endocrine, urinary, musculoskeletal or other disorders
judged to be clinically significant by the investigator
History of SARS-CoV or MERS-CoV infection
History of allergy or hypersensitivity reaction to any components of study vaccine
History of serious adverse reaction, allergy or hypersensitivity reaction to any
vaccination
History of platelet-related disease or hemorrhagic disease, or have a history of
severe bleeding or bruising after intramuscular injection (IM) or venipuncture, or are
taking anticoagulants; (However, according to the judgment of the investigators, there
can be involved when using a low dose of an anticoagulant (eg, aspirin at 100mg/day or
less))
History of urticarial within 5 years before the first vaccination
History of hereditary or idiopathic angioneurotic edema
History of organ or bone marrow transplantation
History or suspicion of illegal substance use or alcohol abuse within the past 6
months before the first vaccination
(Step II only) Previous vaccination history of mRNA based COVID-19 vaccine
Prior administration of an investigational substance vaccine
Receipt of chronic use of the following drugs within 6 months before the first
vaccination
Immunosuppressants and immunomodulators: Azathioprine, cyclosporine, interferon
G-CSF, tacrolimus, everolimus, sirolimus, cyclophosphamide, 6-mercaptopurine
methotrexate, rapamycin, leflunomide, etc
Systemic steroids: When a dose exceeding 10 mg/day and has been used for more
than 14 consecutive days based on prednisolone (However, external steroids, nasal
sprays, inhalants, and eye drops are permitted regardless of the dosage)
History of dependent psychotropic or opioid drug within 6 months before the first
vaccination
Participated in an interventional clinical study within 6 months prior to the
screening visit or plans to do so while participating in this study
Participants have been vaccinated or plan to vaccinate within 4 weeks before/after
each vaccination
Participants have received immunoglobulin or blood-derived products within 3 months
prior to the first vaccination, or those who plan to administer it during the study
Participants scheduled for surgery while participating in this study
Pregnant or lactating at screening or planning to become pregnant (Self or partner) at
any time during the study, including the follow-up period
Any other reason that, in the opinion of the investigator, unlikely to comply with the
clinical study protocol or is unsuitable for any other reason
Any kinds of COVID-19 vaccination history are allowed for Step I, but each
COVID-19 vaccination history is allowed for Step II except mRNA based COVID-19
vaccine. IP should be vaccinated to subject minimal 3 months after last
vaccination of previous COVID-19 vaccine
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How to participate?

Step 1 Connect with a study center
What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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