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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04715997
Recruitment Status : Active, not recruiting
First Posted : January 20, 2021
Last Update Posted : December 9, 2021
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.

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

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Drug: GX-19N Drug: Placebo Phase 1 Phase 2

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 1/2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Subjects
Actual Study Start Date : December 30, 2020
Actual Primary Completion Date : July 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GX-19: Dose A
Dose A of GX-19N will be intramusculary administered via EP on day 1 and day 29.
 Drug: GX-19N
DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen
Other Name: Dose A
Placebo Comparator: Placebo: Normal saline
Placebo will be intramusculary administered via EP on day 1 and day 29.
 Drug: Placebo
Normal saline
Other Name: Normal saline


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Solicited Adverse Events [ Time Frame: Through 1 year post vaccination ]
    solicited local and systemic AEs after vaccination

  2. Incidence of Unsolicited Adverse Events [ Time Frame: Through 1 year post vaccination ]
    unsolicited AEs after vaccination

  3. Incidence of Serious Adverse Events [ Time Frame: Through 1 year post vaccination ]
    percentage of subjects with SAEs


Secondary Outcome Measures :
  1. GMT of Antigen-specific Binding Antibody Titers [ Time Frame: Through 1 year post vaccination ]
    Geometric mean titer (GMT) of antigen-specific binding antibody after vaccination

  2. GMFR of Antigen-specific Binding Antibody Titers [ Time Frame: Through 1 year post vaccination ]
    Geometric mean fold rise (GMFR) of antigen-specific binding antibody after vaccination

  3. Percentage of Subjects Who Seroconverted After Vaccination [ Time Frame: Through 1 year post vaccination ]
    Seroconversion defines when FRNT50 is detected more than four times from the baseline after vaccination

  4. GMT and GMFR of Neutralizing Antibody Level [ Time Frame: Through 1 year post vaccination ]
    Geometric mean titer (GMT) and Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination

  5. GMFR of Neutralizing Antibody Level [ Time Frame: Through 1 year post vaccination ]
    Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination

  6. GMSN and GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay [ Time Frame: Through 1 year post vaccination ]
    Geometric mean spot numbers (GMSN) and Geometric mean fold rise (GMFR) of SFU after vaccination


Other Outcome Measures:
  1. Change From Baseline in Antigen-specific IFN-gamma Cellular Immune Response [ Time Frame: Through 1 year post vaccination ]
    Antigen-specific IFN-γ T cell immune response assessed after vaccination


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715997


Locations
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Korea, Republic of
KyungHee University Medical Center
Seoul, Korea, Republic of, 02447
Severance Hospital
Seoul, Korea, Republic of, 03722
Hanyang University Hospital
Seoul, Korea, Republic of, 04763
Gangnam Severance Hospital
Seoul, Korea, Republic of, 06273
Ajou University Hospital
Suwon, Korea, Republic of, 16499
Sponsors and Collaborators
Genexine, Inc.
Investigators
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Study Director: JungWon Woo, Ph.D. Genexine, Inc.
Principal Investigator: Jun Yong Choi, MD Severance Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT04715997    
Other Study ID Numbers: GX-19N-HV-002
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: December 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No