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Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals

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: NCT04915989
Recruitment Status : Active, not recruiting
First Posted : June 7, 2021
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.

Study Description
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Brief Summary:
The objective of our study is to demonstrate safety and immunogenicity of COVID-19 preventive DNA vaccine in elderly individuals.

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

Detailed Description:

This clinical study is a phase 1 clinical trial to investigate the safety and immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in the elderly.

This study is designed as single arm, open-labeled and a total of 30 subjects will be enrolled.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 1, Multicenter, Open-Label, Single Arm Study to Investigate the Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals
Actual Study Start Date : February 16, 2021
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GX-19N
Dose A of GX-19N will be intramusculary administered via EP on day 1 and day 29. (Optional administration on day 57)
 Drug: GX-19N
DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen
Other Name: Dose A


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 12 weeks after vaccination ]
    Geometric mean titer (GMT) of antigen-specific binding antibody after vaccination

  2. GMFR of Antigen-specific Binding Antibody Titers [ Time Frame: Through 12 weeks after vaccination ]
    Geometric mean fold rise (GMFR) of antigen-specific binding antibody after vaccination

  3. Percentage of Subjects Who Seroconverted After Vaccination [ Time Frame: Through 12 weeks after vaccination ]
    Seroconversion defines as 4-fold increase in antibody titer after vaccination

  4. GMT of Neutralizing Antibody Level [ Time Frame: Through 12 weeks after vaccination ]
    Geometric mean titer (GMT) of neutralizing antibody after vaccination

  5. GMFR of Neutralizing Antibody Level [ Time Frame: Through 12 weeks after vaccination ]
    Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination

  6. GMSN of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay [ Time Frame: Through 12 weeks after vaccination ]
    Geometric mean spot numbers (GMSN) of SFU after vaccination

  7. GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay [ Time Frame: Through 12 weeks after vaccination ]
    Geometric mean fold rise (GMFR) of SFU after vaccination


Other Outcome Measures:
  1. Change From Baseline in Antigen-specific IFN-gamma Cellular Immune Response by Immunophenotyping assay [ Time Frame: Through 12 weeks after vaccination ]
    Antigen-specific IFN-γ T cell immune response assessed by immunophenotyping assay after vaccination


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older 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
  • Male or female aged 55-85 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 with significant chronic underlying diseases that may increase the risk of COVID-19 or interfere with the evaluation of clinical trial purposes according to the investigator's discretion
  • 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): NCT04915989


Locations
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Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 03722
Gangnam Severance hospital
Seoul, Korea, Republic of, 06273
Sponsors and Collaborators
Genexine, Inc.
Investigators
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Principal Investigator: Jun Yong Choi, MD Severance Hospital
More Information
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Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT04915989    
Other Study ID Numbers: GX-19N-HV-003
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 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