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

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

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Sponsors and Collaborators

Genexine, Inc.

PT Kalbe Farma TBK

Investigators

• Study Director: JungWon Woo, Ph.D.; Genexine, Inc.

More Information

• Responsible Party: Genexine, Inc.
• ClinicalTrials.gov Identifier: NCT05067946
• Other Study ID Numbers: GX-19N-HV-004
• First Posted: October 5, 2021
• Last Update Posted: October 5, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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