Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults

Genexine

Status and phase

Unknown

Phase 2

Phase 1

Conditions

SARS-CoV-2

Treatments

Drug: GX-19N

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04715997

GX-19N-HV-002

Details and patient eligibility

About

The objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.

Full 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 of this study is designed as single arm, open-labeled and a total of 20 subjects will be enrolled. Phase 2a of study is designed as randomized, double-blind, placebo controlled and a total of 150 subjects are planned to be enrolled.

Enrollment

170 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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