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

Sponsor
Genexine, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04715997
Collaborator
(none)
170
Enrollment
5
Locations
2
Arms
18
Anticipated Duration (Months)
34
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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 :
Dec 30, 2020
Actual Primary Completion Date :
Jul 30, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • Normal saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Solicited Adverse Events [Through 1 year post vaccination]

      solicited local and systemic AEs after vaccination

    2. Incidence of Unsolicited Adverse Events [Through 1 year post vaccination]

      unsolicited AEs after vaccination

    3. Incidence of Serious Adverse Events [Through 1 year post vaccination]

      percentage of subjects with SAEs

    Secondary Outcome Measures

    1. GMT of Antigen-specific Binding Antibody Titers [Through 1 year post vaccination]

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

    2. GMFR of Antigen-specific Binding Antibody Titers [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 [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 [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 [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 [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 [Through 1 year post vaccination]

      Antigen-specific IFN-γ T cell immune response assessed after vaccination

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 KyungHee University Medical Center Seoul Korea, Republic of 02447
    2 Severance Hospital Seoul Korea, Republic of 03722
    3 Hanyang University Hospital Seoul Korea, Republic of 04763
    4 Gangnam Severance Hospital Seoul Korea, Republic of 06273
    5 Ajou University Hospital Suwon Korea, Republic of 16499

    Sponsors and Collaborators

    • Genexine, Inc.

    Investigators

    • Study Director: JungWon Woo, Ph.D., Genexine, Inc.
    • Principal Investigator: Jun Yong Choi, MD, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genexine, Inc.
    ClinicalTrials.gov Identifier:
    NCT04715997
    Other Study ID Numbers:
    • GX-19N-HV-002
    First Posted:
    Jan 20, 2021
    Last Update Posted:
    Dec 9, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 9, 2021