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

NCT04445389 | Terminated Phase 1 DMC

• 1 other identifier: GX-19-HV-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• Incidence of solicited adverse events

  solicited local and systemic AEs after vaccination

  Through 1 year post vaccination

• Incidence of unsolicited adverse events

  unsolicited AEs after vaccination

  Through 1 year post vaccination

• Incidence of serious adverse events

  percentage of subjects with SAEs

  Through 1 year post vaccination

Secondary Outcomes (4)

• Geometric mean titer (GMT) of antigen-specific binding antibody titers

  Through 1 year post vaccination

• Percentage of subjects who seroconverted after vaccination

  Through 1 year post vaccination

• Geometric mean titer (GMT) of neutralizing antibody level

  Through 1 year post vaccination

• Geometric mean fold rise (GMFR) of antigen-specific binding antibody titers

  Through 1 year post vaccination

Other Outcomes (1)

• Change from baseline in antigen-specific IFN-g cellular immune response

  Through 1 year post vaccination

Study Arms (4)

GX-19: Dose A

EXPERIMENTAL

Dose A of GX-19 will be intramusculary administered via EP on day 1 and day 29.

Drug: GX-19

GX-19: Dose B

EXPERIMENTAL

Dose B of GX-19 will be intramusculary administered via EP on day 1 and day 29.

Drug: GX-19

GX-19: Dose C

PLACEBO COMPARATOR

Dose C of GX-19 will be intramusculary administered via PharmaJet® Needle Free Delivery on day 1 and day 29.

Drug: GX-19

Placebo: Dose A, B, or C

PLACEBO COMPARATOR

Placebo will be intramusculary administered on day 1 and day 29 via EP or PharmaJet® Needle Free Delivery

Drug: Saline

Interventions

GX-19 DRUG

DNA vaccine expressing SARS-CoV-2 S-protein antigen

Also known as: DNA vaccine expressing SARS-CoV-2 S-protein antigen

GX-19: Dose A; GX-19: Dose B; GX-19: Dose C

Saline DRUG

Saline

Placebo: Dose A, B, or C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (1)

Severance hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• JungWon Woo, Ph.D.

  Genexine, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 24, 2020
• Study Start: June 17, 2020
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: August 20, 2025

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)