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

  • STATUS
    Recruiting
  • participants needed
    210
  • sponsor
    Genexine, Inc.
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Updated on 19 February 2024
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body mass index
covid-19
dna vaccine

Summary

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

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 dose escaltion, single arm, open-labeled and a total of 60 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.

Details
Condition SARS-CoV-2
Age 18years - 50years
Treatment Saline, GX-19
Clinical Study IdentifierNCT04445389
SponsorGenexine, Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Each participant must meet all of the following criteria during the screening
period
Able and willing to comply with all study procedures and voluntarily signs informed consent form
Healthy adult male or female aged 19-50 years
Those who weigh 50 kg to 90kg and have a body mass index (BMI) of 18.0 kg/m2 to 28.0 kg/m2 at screening visit
Willing to provide specimens such as blood and urine during the study, including end of study visit

Exclusion Criteria

Participants meeting any of the following criteria at the Screening Visit
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 serum 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-19 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
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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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