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Safety and Immunogenicity Study of GX-19, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445389
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.

Tracking Information
First Submitted Date  ICMJE June 19, 2020
First Posted Date  ICMJE June 24, 2020
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE June 17, 2020
Estimated Primary Completion Date March 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
  • Incidence of solicited adverse events [ Time Frame: Through 1 year post vaccination ]
    solicited local and systemic AEs after vaccination
  • Incidence of unsolicited adverse events [ Time Frame: Through 1 year post vaccination ]
    unsolicited AEs after vaccination
  • Incidence of serious adverse events [ Time Frame: Through 1 year post vaccination ]
    percentage of subjects with SAEs
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
Safety and tolerability [ Time Frame: Through 1 year post vaccination ]
(Un)solicited local and systemic adverse reactions
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
  • Geometric mean titer (GMT) of antigen-specific binding antibody titers [ Time Frame: Through 1 year post vaccination ]
    Change from baseline in antigen-specific binding antibody titers
  • Percentage of subjects who seroconverted after vaccination [ Time Frame: Through 1 year post vaccination ]
    Seroconversion rate can be calculated based on test results reaching the quantifiable antibody level after vaccination
  • Geometric mean titer (GMT) of neutralizing antibody level [ Time Frame: Through 1 year post vaccination ]
    NAb is regarded as produced when FRNT50 is detected more than four times the baseline after vaccination
  • Geometric mean fold rise (GMFR) of antigen-specific binding antibody titers [ Time Frame: Through 1 year post vaccination ]
    Change from baseline in antigen-specific binding antibody titers
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
  • Titer of SARS-CoV-2-specific binding antibody [ Time Frame: Through 1 year post vaccination ]
    Antibody titer compare to baseline (GMT, GMFR)
  • Seroconversion rate (%) [ Time Frame: Through 1 year post vaccination ]
    Seroconversion as measured by an increase of SARS-CoV-2-specific antibody titer
  • Titer of SARS-CoV-2-specific neutralizing antibody (nAb) [ Time Frame: Through 1 year post vaccination ]
Current Other Pre-specified Outcome Measures
 (submitted: June 24, 2020)
Change from baseline in antigen-specific IFN-g cellular immune response [ Time Frame: Through 1 year post vaccination ]
Antigen-specific IFN-γ T cell immune response assessed before/after vaccination
Original Other Pre-specified Outcome Measures
 (submitted: June 22, 2020)
IFN-r Elispost assay [ Time Frame: Through 1 year post vaccination ]
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy Adults
Official Title  ICMJE A Phase 1/2a, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Immunogenicity of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy Subjects
Brief Summary The objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV-2
Intervention  ICMJE
  • Drug: GX-19
    DNA vaccine expressing SARS-CoV-2 S-protein antigen
    Other Name: DNA vaccine expressing SARS-CoV-2 S-protein antigen
  • Drug: Saline
    Saline
Study Arms  ICMJE
  • Experimental: GX-19: Dose A
    Dose A of GX-19 will be intramusculary administered via EP on day 1 and day 29.
    Intervention: Drug: GX-19
  • Experimental: GX-19: Dose B
    Dose B of GX-19 will be intramusculary administered via EP on day 1 and day 29.
    Intervention: Drug: GX-19
  • Placebo Comparator: GX-19: Dose C
    Dose C of GX-19 will be intramusculary administered via PharmaJet® Needle Free Delivery on day 1 and day 29.
    Intervention: Drug: GX-19
  • Placebo Comparator: Placebo: Dose A, B, or C
    Placebo will be intramusculary administered on day 1 and day 29 via EP or PharmaJet® Needle Free Delivery
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2020)
210
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2020)
190
Estimated Study Completion Date  ICMJE June 17, 2022
Estimated Primary Completion Date March 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Each participant must meet all of the following criteria during the screening period:

  1. Able and willing to comply with all study procedures and voluntarily signs informed consent form
  2. Healthy adult male or female aged 19-50 years
  3. 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.
  4. 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:

  1. Immunosuppresion including immunodeficiency disease or family history
  2. Any history of malignant disease within the past 5 years
  3. Scheduled to undergo any surgery or dental treatment during the study
  4. Having received immunoglobulin or blood-derived drugs or being expected to be administered within 3 months prior to administration.
  5. Having relied on antipsychotic drugs and narcotic analgesics within 6 months before administration
  6. Positive of serum test at screening
  7. Suspected of drug abuse or a history within 12 months prior to administration
  8. Active alcohol use or history of alcohol abuse
  9. 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
  10. History of hypersensitivity to vaccination such as Guillain-Barre syndrome
  11. 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)
  12. Having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants
  13. 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
  14. Acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration
  15. Other vaccination history within 28 days prior to the administration or being scheduled to be inoculated during the study
  16. History of having taken immunosuppressant or Immune modifying drug within 3 months prior to administration
  17. Having participated and had clinical trial drug administration in another clinical trial or biological equivalence study within 6 months prior to the administration
  18. 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
  19. Fertile female who do not agree to use effective contraception methods (condoms, contraceptive diaphragm, intrauterine contraceptive devices) during the study
  20. Any other clinically significant medical or psychiatric finding which is considered inappropriate by investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Yoon-Jeong Choi, M.S. 82-31-628-3233 yoonjeong.choi@genexine.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04445389
Other Study ID Numbers  ICMJE GX-19-HV-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Genexine, Inc.
Study Sponsor  ICMJE Genexine, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: JungWon Woo, Ph.D. Genexine, Inc.
PRS Account Genexine, Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP