Safety and Immunogenicity of COVID-19 Vaccine, AdCLD-CoV19-1
- Conditions
- COVID19
- Registration Number
- PACTR202210848418417
- Lead Sponsor
- Cellid
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 200
1.Healthy individual aged 19 years and above at consentconsent.
2.Individual willing to provide written informed consent to participate study voluntarily.
3.Individuals who can be followed up during the study period and can comply with the study requirements.
4.Individual who agrees not to donate blood during the study participation
5.Females of childbearing potential with negative serum or urinary pregnancy test on the day of screening.
6.Females of childbearing potential who are using an effective birth control method* for at least 4 weeks before the screening and during the study participation.
1.Prior SARS-CoV-2 infection confirmed by a rapid antibody kit at screening.
2. History of receiving any vaccine (licensed or investigational) for SARS-CoV-2.
3. History of SARS-CoV-1 or MERS vaccination and treatment.
4.Individual determined to be clinically significantly abnormal by the screening outcome based on medical history, physical examination, laboratory evaluations (negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, and Human Immunodeficiency Virus (HIV) antibody), electrocardiogram (ECG) and Chest X-ray, and the clinical judgment of the investigator.
5. Individual who has received other vaccines from 4 weeks prior to the first dose of test vaccination or planned to receive any vaccine within 4 weeks of the last dose of the study vaccine.
6. Febrile illness (tympanic temperature = 38°C) or acute illness with any clinically significant,, respiratory symptoms (e.g., sore throat, cough, sputum) within 3 days prior to the study vaccination.
7. Known history or allergy to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial (e.g., Guillain-Barre Syndrome).
8. Individual with major congenital abnormalities, which in the opinion of investigator may affect the participant’s participation in the study.
9. Chronic use of systemic steroids (>10 mg/day prednisone equivalent for periods exceeding 14 days), cytotoxic or other immunosuppressive drugs within the past 6 weeks.
10. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental to the safety of the participant and interfere with the assessment of the study objectives.
11. Individual with hereditary or idiopathic angioneurotic edema
12. Individual concomitantly enrolled or scheduled to be enrolled in another trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method