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COMPLETEDPHASE1

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

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.

NCT05047692•Cellid Co., Ltd.

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

19 - 64 years

Sex

ALL

Healthy Volunteers

Yes

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.
+20 more criteria

Locations (3)

Korea University Ansan Hospital

Ansan, Province, South Korea

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

Suwon, Province, South Korea

Korea University Guro Hospital

Seoul, State, South Korea

Key Dates

Start Date

September 9, 2021

Primary Completion Date

December 2, 2022

Completion Date

June 21, 2023

Last Updated

July 28, 2023

Enrollment

ACTUAL participants

Conditions

Covid19

Interventions

AdCLD-CoV19-1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The Effect of the Covid-19 Pandemic Among Operated Patients

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

Covid-19 and Influenza Oral Vaccine Study

Conversations You Want About Corona Virus Disease (COVID-19)

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