Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults

SARS-CoV-2 Clinical Trial

Official title:

A Phase 1/2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04715997
• Other study ID #: GX-19N-HV-002
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: December 30, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2021
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.

Description:

This clinical study is phase 1/2a clinical trial to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in healthy volunteers. Phase 1 of this study is designed as single arm, open-labeled and a total of 20 subjects will be enrolled. Phase 2a of study is designed as randomized, double-blind, placebo controlled and a total of 150 subjects are planned to be enrolled.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: June 30, 2022
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Able and willing to comply with all study procedures and voluntarily signs informed consent form
• Healthy adult male or female aged 19-55 years
• Willing to provide specimens such as blood and urine during the study, including end of study visit.

Exclusion Criteria:

• Immunosuppresion 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 who have or with a history of disease corresponding to other hepatobiliary, kidneys, nervous systems (middle or peripheral), respiratory machines (e.g. asthma, pneumonia, etc., endocrine systems (uncontrolled diabetes, hyperlipidemia, etc.) and cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension), blood tumors, urinary machines, mental, musculoskeletal systems, immune system (rheumatoid arthritis, systemic arthritis, mumps, immunodeficiency disease)
• 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
• Placebo
Normal saline

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hanyang University Hospital	Seoul
Korea, Republic of	KyungHee University Medical Center	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

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	Antigen-specific IFN-? T cell immune response assessed after vaccination	Through 1 year post vaccination
Primary	Incidence of Solicited Adverse Events	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 Events	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 1 year post vaccination
Secondary	GMFR of Antigen-specific Binding Antibody Titers	Geometric mean fold rise (GMFR) of antigen-specific binding antibody after vaccination	Through 1 year post vaccination
Secondary	Percentage of Subjects Who Seroconverted After Vaccination	Seroconversion defines when FRNT50 is detected more than four times from the baseline after vaccination	Through 1 year post vaccination
Secondary	GMT and GMFR of Neutralizing Antibody Level	Geometric mean titer (GMT) and Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination	Through 1 year post vaccination
Secondary	GMFR of Neutralizing Antibody Level	Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination	Through 1 year post vaccination
Secondary	GMSN and GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay	Geometric mean spot numbers (GMSN) and Geometric mean fold rise (GMFR) of SFU after vaccination	Through 1 year post vaccination