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

NCT04915989 | Completed Phase 1

• 1 other identifier: GX-19N-HV-003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• Incidence of Solicited Adverse Event(AE)s

  solicited local and systemic AEs after vaccination

  Through 1 year post vaccination

• Incidence of Unsolicited Adverse Events

  unsolicited 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 Outcomes (7)

• GMT of Antigen-specific Binding Antibody Titers

  Through 12 weeks after vaccination

• GMFR of Antigen-specific Binding Antibody Titers

  Through 12 weeks after vaccination

• Percentage of Subjects Who Seroconverted After Vaccination

  Through 12 weeks after vaccination

• GMT of Neutralizing Antibody Level

  Through 12 weeks after vaccination

• GMFR of Neutralizing Antibody Level

  Through 12 weeks after vaccination

Other Outcomes (1)

• Change From Baseline in Antigen-specific IFN-gamma Cellular Immune Response by Immunophenotyping assay

  Through 12 weeks after vaccination

Study Arms (1)

GX-19N

EXPERIMENTAL

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

Interventions

GX-19N DRUG

DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen

Also known as: Dose A

GX-19N

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (2)

Severance hospital

Seoul, 03722, South Korea

Location

Gangnam Severance hospital

Seoul, 06273, South Korea

Location

MeSH Terms

Interventions

GX-19N vaccine

Study Officials

• Jun Yong Choi, MD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 7, 2021
• Study Start: February 16, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)