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

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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.

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.

Condition or disease Intervention/treatment Phase
SARS-CoV2 Infection Biological: GX-19N Other: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Arm Intervention/treatment
Experimental: GX-19N
GX-19N will be intramusculary administered via EP on day 1 and day 29.
Biological: GX-19N
DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen

Placebo Comparator: Placebo
Placebo will be intramusculary administered via EP on day 1 and day 29
Other: Placebo
GX-19N formulation buffer




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  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


Other Outcome Measures:
  1. 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

  2. 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



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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT05067946


Contacts
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Contact: Minkyu Heo 82-31-628-3340 mkheo@genexine.com

Sponsors and Collaborators
Genexine, Inc.
PT Kalbe Farma TBK
Investigators
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Study Director: JungWon Woo, Ph.D. Genexine, Inc.
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Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT05067946    
Other Study ID Numbers: GX-19N-HV-004
First Posted: October 5, 2021    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases