Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines
Primary Purpose
SARS-CoV2 Infection
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
GX-19N
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for SARS-CoV2 Infection
Eligibility Criteria
Inclusion Criteria:
- Adult males or females aged 18 years and above at the time of consent
- Healthy subjects in normal medical condition as determined by medical history, physical examination, and investigator's discretion
- 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
- Negative results for SARS-COV-2 rapid antigen test at the screening period
- Able to comply with all study procedures and requirements
- Agree for blood and nasal swab samples could be collected throughout the study period, including surveillance visit
Exclusion Criteria:
- Unable to follow clinical and follow-up procedures
- 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
- History of SARS-CoV-2 infection or have experienced prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine
- History of a malignant disease within the past 5 years
- Immune dysfunction, including immunodeficiency disorder, or family history of such conditions (Except stable/well-controlled HIV-positive participants)
- Have received immunoglobulin or blood-derived products within 3 months prior to the vaccination or are scheduled to receive them during the study period
- Have been dependent on antipsychotic drugs and narcotic analgesics within 6 months prior to the vaccination
- History or are suspected of alcohol or drug dependency
- History of hypersensitivity or allergic reactions including anaphylaxis
- 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
- Hemophiliacs or people using anticoagulants who are at a risk of serious bleeding from IM injection
- 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)
- 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)
- Female who are pregnant or breastfeeding; however, participation is possible if breastfeeding is discontinued prior to participation in the study
- 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
- Not consent to the use of effective contraception at least 90 days after the last vaccination
- Lack of acceptable sites available for IM injection and EP
- Deemed ineligible by the investigator based on other clinically significant medical or psychiatric findings
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GX-19N
Placebo
Arm Description
GX-19N will be intramusculary administered via EP on day 1 and day 29.
Placebo will be intramusculary administered via EP on day 1 and day 29
Outcomes
Primary Outcome Measures
First occurrence of COVID-19 at least 14 days after the second vaccination
Symptomatic, virologically confirmed COVID-19 as described in the study
Incidence of severe solicited adverse events (AEs)
Percentage of subjects reporting grade 3 or higher AEs after each vaccination
Incidence of AEs and Serious AEs (SAEs) 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
SAE and AESIs reported in all subjects at any time after the first vaccination
Secondary Outcome Measures
First occurrence of severe COVID-19 at least 14 days after the second vaccination
Symptomatic, virologically confirmed severe COVID-19 as described in the study
Cell-mediated immune responses after vaccination
Antigen-specific T cell response in a subset of Phase 2/3
Antibody responses after vaccination
Analysis of binding antibodies and neutralizing antibodies in a subset of Phase 2/3
Full Information
NCT ID
NCT05067946
First Posted
October 4, 2021
Last Updated
April 4, 2022
Sponsor
Genexine, Inc.
Collaborators
PT Kalbe Farma Tbk
1. Study Identification
Unique Protocol Identification Number
NCT05067946
Brief Title
Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Change of development strategy in consideration of the global COVID-19 situation
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genexine, Inc.
Collaborators
PT Kalbe Farma Tbk
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV2 Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GX-19N
Arm Type
Experimental
Arm Description
GX-19N will be intramusculary administered via EP on day 1 and day 29.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be intramusculary administered via EP on day 1 and day 29
Intervention Type
Biological
Intervention Name(s)
GX-19N
Intervention Description
DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
GX-19N formulation buffer
Primary Outcome Measure Information:
Title
First occurrence of COVID-19 at least 14 days after the second vaccination
Description
Symptomatic, virologically confirmed COVID-19 as described in the study
Time Frame
Up to 1 year after first vaccination
Title
Incidence of severe solicited adverse events (AEs)
Description
Percentage of subjects reporting grade 3 or higher AEs after each vaccination
Time Frame
Up to 7 days after each vaccination
Title
Incidence of AEs and Serious AEs (SAEs) after each vaccination
Description
Percentage of subjects reporting AEs and SAEs after each vaccination
Time Frame
Up to 1 month after each vaccination
Title
Incidence of SAE, and Adverse events of special interest (AESIs), which relevant to COVID-19 including possible vaccine-enhanced disease
Description
SAE and AESIs reported in all subjects at any time after the first vaccination
Time Frame
Up to 1 year after first vaccination
Secondary Outcome Measure Information:
Title
First occurrence of severe COVID-19 at least 14 days after the second vaccination
Description
Symptomatic, virologically confirmed severe COVID-19 as described in the study
Time Frame
Up to 1 year after first vaccination
Title
Cell-mediated immune responses after vaccination
Description
Antigen-specific T cell response in a subset of Phase 2/3
Time Frame
Up to 1 year after first vaccination
Title
Antibody responses after vaccination
Description
Analysis of binding antibodies and neutralizing antibodies in a subset of Phase 2/3
Time Frame
Up to 1 year after first vaccination
Other Pre-specified Outcome Measures:
Title
First occurrence of COVID-19 at least 14 days after the first vaccination
Description
Symptomatic, virologically confirmed COVID-19 as described in the study
Time Frame
Up to 1 year after first vaccination
Title
First occurrence of asymptomatic, virologically confirmed COVID-19 at least 14 days after the last vaccination in subjects
Description
Without symptom, but virologically confirmed COVID-19 as described in the study
Time Frame
Up to 1 year after first vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult males or females aged 18 years and above at the time of consent
Healthy subjects in normal medical condition as determined by medical history, physical examination, and investigator's discretion
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
Negative results for SARS-COV-2 rapid antigen test at the screening period
Able to comply with all study procedures and requirements
Agree for blood and nasal swab samples could be collected throughout the study period, including surveillance visit
Exclusion Criteria:
Unable to follow clinical and follow-up procedures
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
History of SARS-CoV-2 infection or have experienced prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine
History of a malignant disease within the past 5 years
Immune dysfunction, including immunodeficiency disorder, or family history of such conditions (Except stable/well-controlled HIV-positive participants)
Have received immunoglobulin or blood-derived products within 3 months prior to the vaccination or are scheduled to receive them during the study period
Have been dependent on antipsychotic drugs and narcotic analgesics within 6 months prior to the vaccination
History or are suspected of alcohol or drug dependency
History of hypersensitivity or allergic reactions including anaphylaxis
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
Hemophiliacs or people using anticoagulants who are at a risk of serious bleeding from IM injection
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)
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)
Female who are pregnant or breastfeeding; however, participation is possible if breastfeeding is discontinued prior to participation in the study
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
Not consent to the use of effective contraception at least 90 days after the last vaccination
Lack of acceptable sites available for IM injection and EP
Deemed ineligible by the investigator based on other clinically significant medical or psychiatric findings
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JungWon Woo, Ph.D.
Organizational Affiliation
Genexine, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines
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