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

Genexine

Status and phase

Withdrawn

Phase 3

Phase 2

Conditions

SARS-CoV2 Infection

Treatments

Biological: GX-19N

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05067946

GX-19N-HV-004

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
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
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
Lack of acceptable sites available for IM injection and EP
Deemed ineligible by the investigator based on other clinically significant medical or psychiatric findings