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

NCT05067946 | Withdrawn Phase 2

• 1 other identifier: GX-19N-HV-004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• First occurrence of severe COVID-19 at least 14 days after the second vaccination

  Up to 1 year after first vaccination

• Cell-mediated immune responses after vaccination

  Up to 1 year after first vaccination

• Antibody responses after vaccination

  Up to 1 year after first vaccination

Other Outcomes (2)

• First occurrence of COVID-19 at least 14 days after the first vaccination

  Up to 1 year after first vaccination

• First occurrence of asymptomatic, virologically confirmed COVID-19 at least 14 days after the last vaccination in subjects

  Up to 1 year after first vaccination

Study Arms (2)

GX-19N

EXPERIMENTAL

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

Biological: GX-19N

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

GX-19N BIOLOGICAL

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

GX-19N

Placebo OTHER

GX-19N formulation buffer

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males or females aged 18 years and above at the time of consent
• Healthy subjects in normal medical condition as determined by medical history, physical examination, and investigator's discretion
• 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
• Negative results for SARS-COV-2 rapid antigen test at the screening period
• Able to comply with all study procedures and requirements
• Agree for blood and nasal swab samples could be collected throughout the study period, including surveillance visit

You may not qualify if:

• Unable to follow clinical and follow-up procedures
• 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
• History of SARS-CoV-2 infection or have experienced prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine
• History of a malignant disease within the past 5 years
• Immune dysfunction, including immunodeficiency disorder, or family history of such conditions (Except stable/well-controlled HIV-positive participants)
• Have received immunoglobulin or blood-derived products within 3 months prior to the vaccination or are scheduled to receive them during the study period
• Have been dependent on antipsychotic drugs and narcotic analgesics within 6 months prior to the vaccination
• History or are suspected of alcohol or drug dependency
• History of hypersensitivity or allergic reactions including anaphylaxis
• Hemophiliacs or people using anticoagulants who are at a risk of serious bleeding from IM injection
• 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)
• 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)
• Female who are pregnant or breastfeeding; however, participation is possible if breastfeeding is discontinued prior to participation in the study
• 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
• Not consent to the use of effective contraception at least 90 days after the last vaccination

Sponsors & Collaborators

• Genexine, Inc.: lead
• PT Kalbe Farma Tbk: collaborator

MeSH Terms

Conditions

COVID-19

Interventions

GX-19N vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• JungWon Woo, Ph.D.

  Genexine, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 5, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: April 12, 2022

Record last verified: 2021-07