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

SARS-CoV-2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04915989
• Other study ID #: GX-19N-HV-003
• Status: Completed
• Phase: Phase 1
• Start date: February 16, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: February 2024
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Drug:
• GX-19N
DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance hospital	Seoul
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Antigen-specific IFN-gamma Cellular Immune Response by Immunophenotyping assay	Antigen-specific IFN-? T cell immune response assessed by immunophenotyping assay after vaccination	Through 12 weeks after vaccination
Primary	Incidence of Solicited Adverse Event(AE)s	solicited local and systemic AEs after vaccination	Through 1 year post vaccination
Primary	Incidence of Unsolicited Adverse Events	unsolicited AEs after vaccination	Through 1 year post vaccination
Primary	Incidence of Serious Adverse Event(SAE)s	percentage of subjects with SAEs	Through 1 year post vaccination
Secondary	GMT of Antigen-specific Binding Antibody Titers	Geometric mean titer (GMT) of antigen-specific binding antibody after vaccination	Through 12 weeks after vaccination
Secondary	GMFR of Antigen-specific Binding Antibody Titers	Geometric mean fold rise (GMFR) of antigen-specific binding antibody after vaccination	Through 12 weeks after vaccination
Secondary	Percentage of Subjects Who Seroconverted After Vaccination	Seroconversion defines as 4-fold increase in antibody titer after vaccination	Through 12 weeks after vaccination
Secondary	GMT of Neutralizing Antibody Level	Geometric mean titer (GMT) of neutralizing antibody after vaccination	Through 12 weeks after vaccination
Secondary	GMFR of Neutralizing Antibody Level	Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination	Through 12 weeks after vaccination
Secondary	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
Secondary	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