Clinical trial NCT04915989: Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: SARS-CoV-2
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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 criteria: 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

Primary outcomes:
measure: Incidence of Solicited Adverse Event(AE)s
timeFrame: Through 1 year post vaccination
measure: Incidence of Unsolicited Adverse Events
timeFrame: Through 1 year post vaccination
measure: Incidence of Serious Adverse Event(SAE)s
timeFrame: Through 1 year post vaccination
Secondary outcomes:
measure: GMT of Antigen-specific Binding Antibody Titers
timeFrame: Through 12 weeks after vaccination
measure: GMFR of Antigen-specific Binding Antibody Titers
timeFrame: Through 12 weeks after vaccination
measure: Percentage of Subjects Who Seroconverted After Vaccination
timeFrame: Through 12 weeks after vaccination
measure: GMT of Neutralizing Antibody Level
timeFrame: Through 12 weeks after vaccination
measure: GMFR of Neutralizing Antibody Level
timeFrame: Through 12 weeks after vaccination
measure: GMSN of Spot Forming Unit (SFU) detected by interferon(IFN)-gamma ELISPOT assay
timeFrame: Through 12 weeks after vaccination
measure: GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay
timeFrame: Through 12 weeks after vaccination
Other outcomes:
measure: Change From Baseline in Antigen-specific IFN-gamma Cellular Immune Response by Immunophenotyping assay
timeFrame: Through 12 weeks after vaccination
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance hospital
Study officials:
affiliation: Severance Hospital
name: Jun Yong Choi, MD
role: PRINCIPAL_INVESTIGATOR
References: