Status:
COMPLETED
Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults
Lead Sponsor:
Genexine, Inc.
Conditions:
SARS-CoV-2
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.
Detailed Description
This clinical study is phase 1/2a clinical trial to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in healthy volunteers. Phase 1 o...
Eligibility Criteria
Inclusion
- Able and willing to comply with all study procedures and voluntarily signs informed consent form
- Healthy adult male or female aged 19-55 years
- Willing to provide specimens such as blood and urine during the study, including end of study visit.
Exclusion
- Immunosuppresion including immunodeficiency disease or family history
- Any history of malignant disease within the past 5 years
- Scheduled to undergo any surgery or dental treatment during the study
- Having received immunoglobulin or blood-derived drugs or being expected to be administered within 3 months prior to administration.
- Having relied on antipsychotic drugs and narcotic analgesics within 6 months before administration
- Positive of serology test at screening
- Suspected of drug abuse or a history within 12 months prior to administration
- Active alcohol use or history of alcohol abuse
- Serious adverse reaction to a drug containing GX-19N or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history
- History of hypersensitivity to vaccination such as Guillain-Barre syndrome
- Those who have or with a history of disease corresponding to other hepatobiliary, kidneys, nervous systems (middle or peripheral), respiratory machines (e.g. asthma, pneumonia, etc., endocrine systems (uncontrolled diabetes, hyperlipidemia, etc.) and cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension), blood tumors, urinary machines, mental, musculoskeletal systems, immune system (rheumatoid arthritis, systemic arthritis, mumps, immunodeficiency disease)
- Having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants
- Subjects who have been contact with COVID-19 infections in the past prior to administration, have been classified as COVID-19 confirmed patients, medical patients or patients with symptoms or have been identified with SARS and MERS infection history in the past
- Acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration
- Other vaccination history within 28 days prior to the administration or being scheduled to be inoculated during the study
- History of having taken immunosuppressant or Immune modifying drug within 3 months prior to administration
- Having participated and had clinical trial drug administration in another clinical trial or biological equivalence study within 6 months prior to the administration
- Pregnant or breastfeeding female, however, those are allowed to participate in the study only if they stop breastfeeding before participation (fertile female† must be negative in serum pregnancy test at screening
- Fertile female who do not agree to use effective contraception methods (condoms, contraceptive diaphragm, intrauterine contraceptive devices) during the study
- Any other clinically significant medical or psychiatric finding which is considered inappropriate by investigator
Key Trial Info
Start Date :
December 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2022
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT04715997
Start Date
December 30 2020
End Date
April 19 2022
Last Update
August 20 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
KyungHee University Medical Center
Seoul, South Korea, 02447
2
Severance Hospital
Seoul, South Korea, 03722
3
Hanyang University Hospital
Seoul, South Korea, 04763
4
Gangnam Severance Hospital
Seoul, South Korea, 06273