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

Sponsor

Genexine, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04445389

Collaborator

(none)

Enrollment

Location

Arms

21.4

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2	Drug: GX-19 Drug: Saline	Phase 1/Phase 2

Detailed 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 dose escaltion, single arm, open-labeled and a total of 60 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Phase 1: Open-label, Dose escalation (3-arms) Phase 2a: Randomized, Double-blinded, Placebo-controlledPhase 1: Open-label, Dose escalation (3-arms) Phase 2a: Randomized, Double-blinded, Placebo-controlled

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 17, 2020

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Mar 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GX-19: Dose A Dose A of GX-19 will be intramusculary administered via EP on day 1 and day 29.	Drug: GX-19 DNA vaccine expressing SARS-CoV-2 S-protein antigen Other Names: DNA vaccine expressing SARS-CoV-2 S-protein antigen
Experimental: GX-19: Dose B Dose B of GX-19 will be intramusculary administered via EP on day 1 and day 29.	Drug: GX-19 DNA vaccine expressing SARS-CoV-2 S-protein antigen Other Names: DNA vaccine expressing SARS-CoV-2 S-protein antigen
Placebo Comparator: GX-19: Dose C Dose C of GX-19 will be intramusculary administered via PharmaJet® Needle Free Delivery on day 1 and day 29.	Drug: GX-19 DNA vaccine expressing SARS-CoV-2 S-protein antigen Other Names: DNA vaccine expressing SARS-CoV-2 S-protein antigen
Placebo Comparator: Placebo: Dose A, B, or C Placebo will be intramusculary administered on day 1 and day 29 via EP or PharmaJet® Needle Free Delivery	Drug: Saline Saline

Outcome Measures

Primary Outcome Measures

Incidence of solicited adverse events [Through 1 year post vaccination]
solicited local and systemic AEs after vaccination
Incidence of unsolicited adverse events [Through 1 year post vaccination]
unsolicited AEs after vaccination
Incidence of serious adverse events [Through 1 year post vaccination]
percentage of subjects with SAEs

Secondary Outcome Measures

Geometric mean titer (GMT) of antigen-specific binding antibody titers [Through 1 year post vaccination]
Change from baseline in antigen-specific binding antibody titers
Percentage of subjects who seroconverted after vaccination [Through 1 year post vaccination]
Seroconversion rate can be calculated based on test results reaching the quantifiable antibody level after vaccination
Geometric mean titer (GMT) of neutralizing antibody level [Through 1 year post vaccination]
NAb is regarded as produced when FRNT50 is detected more than four times the baseline after vaccination
Geometric mean fold rise (GMFR) of antigen-specific binding antibody titers [Through 1 year post vaccination]
Change from baseline in antigen-specific binding antibody titers

Other Outcome Measures

Change from baseline in antigen-specific IFN-g cellular immune response [Through 1 year post vaccination]
Antigen-specific IFN-γ T cell immune response assessed before/after vaccination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Each participant must meet all of the following criteria during the screening period:

Able and willing to comply with all study procedures and voluntarily signs informed consent form
Healthy adult male or female aged 19-50 years
Those who weigh 50 kg to 90kg and have a body mass index (BMI) of 18.0 kg/m2 to 28.0 kg/m2 at screening visit.
Willing to provide specimens such as blood and urine during the study, including end of study visit.

Exclusion Criteria:

Participants meeting any of the following criteria at the Screening Visit:

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 serum 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-19 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance hospital	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

Genexine, Inc.

Investigators

Study Director: JungWon Woo, Ph.D., Genexine, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genexine, Inc.

ClinicalTrials.gov Identifier:

NCT04445389

Other Study ID Numbers:

GX-19-HV-001

First Posted:

Jun 24, 2020

Last Update Posted:

Dec 9, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vaccines

Study Results

No Results Posted as of Dec 9, 2021