Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals

A Phase 1, Multicenter, Open-Label, Single Arm Study to Investigate the Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals

The objective of the study is to demonstrate safety and immunogenicity of COVID-19 preventive DNA vaccine in elderly individuals.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2
• Intervention / Treatment: Drug: GX-19N

Detailed Description

This clinical study is a phase 1 clinical trial to investigate the safety and immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in the elderly.

This study is designed as single arm, open-labeled and a total of 30 subjects will be enrolled.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Able and willing to comply with all study procedures and voluntarily signs informed consent form
• Male or female aged 55-85 years
• Willing to provide specimens such as blood and urine during the study, including end of study visit.

Exclusion Criteria:

• Immunosuppression including immunodeficiency disease or family history Any history of malignant disease within the past 5 years
• Scheduled to undergo any surgery or dental treatment during the study
• Having received immunoglobulin or blood-derived drugs or being expected to be administered within 3 months prior to administration.
• Having relied on antipsychotic drugs and narcotic analgesics within 6 months before administration
• Positive of serology test at screening
• Suspected of drug abuse or a history within 12 months prior to administration
• Active alcohol use or history of alcohol abuse
• Serious adverse reaction to a drug containing GX-19N or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history
• History of hypersensitivity to vaccination such as Guillain-Barre syndrome
• Those with significant chronic underlying diseases that may increase the risk of COVID-19 or interfere with the evaluation of clinical trial purposes according to the investigator's discretion
• Having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants
• Subjects who have been contact with COVID-19 infections in the past prior to administration, have been classified as COVID-19 confirmed patients, medical patients or patients with symptoms or have been identified with SARS and MERS infection history in the past
• Acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration
• Other vaccination history within 28 days prior to the administration or being scheduled to be inoculated during the study
• History of having taken immunosuppressant or Immune modifying drug within 3 months prior to administration
• Having participated and had clinical trial drug administration in another clinical trial or biological equivalence study within 6 months prior to the administration
• Pregnant or breastfeeding female, however, those are allowed to participate in the study only if they stop breastfeeding before participation (fertile female† must be negative in serum pregnancy test at screening
• Fertile female who do not agree to use effective contraception methods (condoms, contraceptive diaphragm, intrauterine contraceptive devices) during the study
• Any other clinically significant medical or psychiatric finding which is considered inappropriate by investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GX-19N; Dose A of GX-19N will be intramuscularly administered via Electroporator(EP) on day 1 and day 29. (Optional administration on day 57)	Drug: GX-19N; DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen; Other Names: Dose A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Unsolicited Adverse Events	unsolicited AEs after vaccination	Through 1 year post vaccination
Incidence of Solicited Adverse Event(AE)s	solicited local and systemic AEs after vaccination	Through 1 year post vaccination
Incidence of Serious Adverse Event(SAE)s	percentage of subjects with SAEs	Through 1 year post vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMT of Antigen-specific Binding Antibody Titers	Geometric mean titer (GMT) of antigen-specific binding antibody after vaccination	Through 12 weeks after vaccination
GMFR of Antigen-specific Binding Antibody Titers	Geometric mean fold rise (GMFR) of antigen-specific binding antibody after vaccination	Through 12 weeks after vaccination
Percentage of Subjects Who Seroconverted After Vaccination	Seroconversion defines as 4-fold increase in antibody titer after vaccination	Through 12 weeks after vaccination
GMT of Neutralizing Antibody Level	Geometric mean titer (GMT) of neutralizing antibody after vaccination	Through 12 weeks after vaccination
GMFR of Neutralizing Antibody Level	Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination	Through 12 weeks after vaccination
GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay	Geometric mean fold rise (GMFR) of SFU after vaccination	Through 12 weeks after vaccination
GMSN of Spot Forming Unit (SFU) detected by interferon(IFN)-gamma ELISPOT assay	Geometric mean spot numbers (GMSN) of SFU after vaccination	Through 12 weeks after vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Antigen-specific IFN-gamma Cellular Immune Response by Immunophenotyping assay	Antigen-specific IFN-γ T cell immune response assessed by immunophenotyping assay after vaccination	Through 12 weeks after vaccination

Collaborators and Investigators

• Sponsor: Genexine, Inc.
• Investigators: Principal Investigator: Jun Yong Choi, MD, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: GX-19N-HV-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No