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

SARS-CoV2 Infection Clinical Trial

Official title:

A Phase 2/3, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GX-19N, A DNA Vaccine, in Healthy Individuals Who Have Received One of the COVID-19 Vaccines

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05067946
• Other study ID #: GX-19N-HV-004
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: October 2021
• Est. completion date: October 2023

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

10. A current or history of clinically significant chronic cardiovascular, endocrine, gastrointestinal, hepatic (including hepatitis B and C), renal, neurological, respiratory, psychiatric or other medical disorders not excluded by other exclusion criteria, that are assessed by the investigator

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV2 Infection

Intervention

Biological:
• GX-19N
DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen

Other:
• Placebo
GX-19N formulation buffer

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Genexine, Inc.	PT Kalbe Farma TBK

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	First occurrence of COVID-19 at least 14 days after the first vaccination	Symptomatic, virologically confirmed COVID-19 as described in the study	Up to 1 year after first vaccination
Other	First occurrence of asymptomatic, virologically confirmed COVID-19 at least 14 days after the last vaccination in subjects	Without symptom, but virologically confirmed COVID-19 as described in the study	Up to 1 year after first vaccination
Primary	First occurrence of COVID-19 at least 14 days after the second vaccination	Symptomatic, virologically confirmed COVID-19 as described in the study	Up to 1 year after first vaccination
Primary	Incidence of severe solicited adverse events (AEs)	Percentage of subjects reporting grade 3 or higher AEs after each vaccination	Up to 7 days after each vaccination
Primary	Incidence of AEs and Serious AEs (SAEs) after each vaccination	Percentage of subjects reporting AEs and SAEs after each vaccination	Up to 1 month after each vaccination
Primary	Incidence of SAE, and Adverse events of special interest (AESIs), which relevant to COVID-19 including possible vaccine-enhanced disease	SAE and AESIs reported in all subjects at any time after the first vaccination	Up to 1 year after first vaccination
Secondary	First occurrence of severe COVID-19 at least 14 days after the second vaccination	Symptomatic, virologically confirmed severe COVID-19 as described in the study	Up to 1 year after first vaccination
Secondary	Cell-mediated immune responses after vaccination	Antigen-specific T cell response in a subset of Phase 2/3	Up to 1 year after first vaccination
Secondary	Antibody responses after vaccination	Analysis of binding antibodies and neutralizing antibodies in a subset of Phase 2/3	Up to 1 year after first vaccination