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Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT04915989•Genexine, Inc.

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

55 - 85 years

Sex

ALL

Healthy Volunteers

Yes

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
+9 more criteria

Locations (2)

Severance hospital

Seoul, South Korea

Gangnam Severance hospital

Seoul, South Korea

Key Dates

Start Date

February 16, 2021

Primary Completion Date

April 1, 2022

Completion Date

April 1, 2022

Last Updated

March 1, 2024

Enrollment

ACTUAL participants

Conditions

SARS-CoV-2

Interventions

GX-19N

DRUG

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Long COVIDSars-CoV-2 Infection+2 more

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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