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Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines

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: NCT05067946
Recruitment Status : Not yet recruiting
First Posted : October 5, 2021
Last Update Posted : October 5, 2021
Sponsor:
Collaborator:
PT Kalbe Farma TBK
Information provided by (Responsible Party):
Genexine, Inc.

Tracking Information
First Submitted Date  ICMJE October 4, 2021
First Posted Date  ICMJE October 5, 2021
Last Update Posted Date October 5, 2021
Estimated Study Start Date  ICMJE October 2021
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2021)
  • First occurrence of COVID-19 at least 14 days after the second vaccination [ Time Frame: Up to 1 year after first vaccination ]
    Symptomatic, virologically confirmed COVID-19 as described in the study
  • Incidence of severe solicited adverse events (AEs) [ Time Frame: Up to 7 days after each vaccination ]
    Percentage of subjects reporting grade 3 or higher AEs after each vaccination
  • Incidence of AEs and Serious AEs (SAEs) after each vaccination [ Time Frame: Up to 1 month after each vaccination ]
    Percentage of subjects reporting AEs and SAEs after each vaccination
  • Incidence of SAE, and Adverse events of special interest (AESIs), which relevant to COVID-19 including possible vaccine-enhanced disease [ Time Frame: Up to 1 year after first vaccination ]
    SAE and AESIs reported in all subjects at any time after the first vaccination
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2021)
  • First occurrence of severe COVID-19 at least 14 days after the second vaccination [ Time Frame: Up to 1 year after first vaccination ]
    Symptomatic, virologically confirmed severe COVID-19 as described in the study
  • Cell-mediated immune responses after vaccination [ Time Frame: Up to 1 year after first vaccination ]
    Antigen-specific T cell response in a subset of Phase 2/3
  • Antibody responses after vaccination [ Time Frame: Up to 1 year after first vaccination ]
    Analysis of binding antibodies and neutralizing antibodies in a subset of Phase 2/3
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 4, 2021)
  • First occurrence of COVID-19 at least 14 days after the first vaccination [ Time Frame: Up to 1 year after first vaccination ]
    Symptomatic, virologically confirmed COVID-19 as described in the study
  • First occurrence of asymptomatic, virologically confirmed COVID-19 at least 14 days after the last vaccination in subjects [ Time Frame: Up to 1 year after first vaccination ]
    Without symptom, but virologically confirmed COVID-19 as described in the study
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines
Official Title  ICMJE A Phase 2/3, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GX-19N, A DNA Vaccine, in Healthy Individuals Who Have Received One of the COVID-19 Vaccines
Brief Summary The purpose of this study is to evaluate the efficacy, safety and immunogenicity of GX-19N in healthy individuals who have received one of COVID-19 vaccine authorized for emergency use.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV2 Infection
Intervention  ICMJE
  • Biological: GX-19N
    DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen
  • Other: Placebo
    GX-19N formulation buffer
Study Arms  ICMJE
  • Experimental: GX-19N
    GX-19N will be intramusculary administered via EP on day 1 and day 29.
    Intervention: Biological: GX-19N
  • Placebo Comparator: Placebo
    Placebo will be intramusculary administered via EP on day 1 and day 29
    Intervention: Other: Placebo
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 4, 2021)
14000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult males or females aged 18 years and above at the time of consent
  2. Healthy subjects in normal medical condition as determined by medical history, physical examination, and investigator's discretion
  3. Have previously received homologous full-dose of COVID-19 vaccine authorized for emergency use, and at least 3 months post second vaccination prior to Day 1
  4. Negative results for SARS-COV-2 rapid antigen test at the screening period
  5. Able to comply with all study procedures and requirements
  6. Agree for blood and nasal swab samples could be collected throughout the study period, including surveillance visit

Exclusion Criteria:

  1. Unable to follow clinical and follow-up procedures
  2. Acute fever with temperature above 38℃, coughing, breathing difficulty, chills, muscle ache, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to the vaccination
  3. History of SARS-CoV-2 infection or have experienced prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine
  4. History of a malignant disease within the past 5 years
  5. Immune dysfunction, including immunodeficiency disorder, or family history of such conditions (Except stable/well-controlled HIV-positive participants)
  6. Have received immunoglobulin or blood-derived products within 3 months prior to the vaccination or are scheduled to receive them during the study period
  7. Have been dependent on antipsychotic drugs and narcotic analgesics within 6 months prior to the vaccination
  8. History or are suspected of alcohol or drug dependency
  9. History of hypersensitivity or allergic reactions including anaphylaxis
  10. A current or history of clinically significant chronic cardiovascular, endocrine, gastrointestinal, hepatic (including hepatitis B and C), renal, neurological, respiratory, psychiatric or other medical disorders not excluded by other exclusion criteria, that are assessed by the investigator
  11. Hemophiliacs or people using anticoagulants who are at a risk of serious bleeding from IM injection
  12. Have received or plans to receive other vaccination(s) within 28 days prior to or during study duration (except for influenza vaccine which is not allowed within 14 days before, or 4 weeks after final dose of IP)
  13. Have taken an immunosuppressant or immune-modifying drug within 3 months prior to the vaccination; chronic administration (defined as more than 14 continuous days) of immunosuppressant medication within the past 3 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days)
  14. Female who are pregnant or breastfeeding; however, participation is possible if breastfeeding is discontinued prior to participation in the study
  15. Have received or have plans to receive other investigational drug(s) while participating in another clinical study or bioequivalence study within 28 days prior to vaccination
  16. Not consent to the use of effective contraception at least 90 days after the last vaccination
  17. Lack of acceptable sites available for IM injection and EP
  18. Deemed ineligible by the investigator based on other clinically significant medical or psychiatric findings
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Minkyu Heo 82-31-628-3340 mkheo@genexine.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05067946
Other Study ID Numbers  ICMJE GX-19N-HV-004
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Genexine, Inc.
Study Sponsor  ICMJE Genexine, Inc.
Collaborators  ICMJE PT Kalbe Farma TBK
Investigators  ICMJE
Study Director: JungWon Woo, Ph.D. Genexine, Inc.
PRS Account Genexine, Inc.
Verification Date July 2021

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