Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines

NCT ID: NCT05067946

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2023-10-31

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and immunogenicity of GX-19N in healthy individuals who have received one of COVID-19 vaccine authorized for emergency use.

Conditions

SARS-CoV2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

GX-19N

GX-19N will be intramusculary administered via EP on day 1 and day 29.

Group Type: EXPERIMENTAL

GX-19N

Intervention Type: BIOLOGICAL

DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen

Placebo

Placebo will be intramusculary administered via EP on day 1 and day 29

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

GX-19N formulation buffer

Interventions

GX-19N

DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen

Intervention Type: BIOLOGICAL

Placebo

GX-19N formulation buffer

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adult males or females aged 18 years and above at the time of consent

2. Healthy subjects in normal medical condition as determined by medical history, physical examination, and investigator's discretion

3. Have previously received homologous full-dose of COVID-19 vaccine authorized for emergency use, and at least 3 months post second vaccination prior to Day 1

4. Negative results for SARS-COV-2 rapid antigen test at the screening period

5. Able to comply with all study procedures and requirements

6. Agree for blood and nasal swab samples could be collected throughout the study period, including surveillance visit

Exclusion Criteria

1. Unable to follow clinical and follow-up procedures

2. Acute fever with temperature above 38℃, coughing, breathing difficulty, chills, muscle ache, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to the vaccination

3. History of SARS-CoV-2 infection or have experienced prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine

4. History of a malignant disease within the past 5 years

5. Immune dysfunction, including immunodeficiency disorder, or family history of such conditions (Except stable/well-controlled HIV-positive participants)

6. Have received immunoglobulin or blood-derived products within 3 months prior to the vaccination or are scheduled to receive them during the study period

7. Have been dependent on antipsychotic drugs and narcotic analgesics within 6 months prior to the vaccination

8. History or are suspected of alcohol or drug dependency

9. History of hypersensitivity or allergic reactions including anaphylaxis

11. Hemophiliacs or people using anticoagulants who are at a risk of serious bleeding from IM injection

12. Have received or plans to receive other vaccination(s) within 28 days prior to or during study duration (except for influenza vaccine which is not allowed within 14 days before, or 4 weeks after final dose of IP)

13. Have taken an immunosuppressant or immune-modifying drug within 3 months prior to the vaccination; chronic administration (defined as more than 14 continuous days) of immunosuppressant medication within the past 3 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days)

14. Female who are pregnant or breastfeeding; however, participation is possible if breastfeeding is discontinued prior to participation in the study

15. Have received or have plans to receive other investigational drug(s) while participating in another clinical study or bioequivalence study within 28 days prior to vaccination

16. Not consent to the use of effective contraception at least 90 days after the last vaccination

17. Lack of acceptable sites available for IM injection and EP

18. Deemed ineligible by the investigator based on other clinically significant medical or psychiatric findings

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PT Kalbe Farma Tbk

INDUSTRY

Sponsor Role: collaborator

Genexine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JungWon Woo, Ph.D.

Role: STUDY_DIRECTOR

Genexine, Inc.

Other Identifiers

GX-19N-HV-004

Identifier Type: -

Identifier Source: org_study_id