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 :
Withdrawn
(Change of development strategy in consideration of the global COVID-19 situation)
First Posted : October 5, 2021
Last Update Posted : April 12, 2022
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Condition or disease | Intervention/treatment | Phase |
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SARS-CoV2 Infection | Biological: GX-19N Other: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 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 |
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Experimental: GX-19N
GX-19N will be intramusculary administered via EP on day 1 and day 29.
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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
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Other: Placebo
GX-19N formulation buffer |
- 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
- 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
- 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

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Study Director: | JungWon Woo, Ph.D. | Genexine, Inc. |
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: | April 12, 2022 |
Last Verified: | July 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |