NCT05067946撤回2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- First occurrence of COVID-19 at least 14 days after the second vaccination
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
First occurrence of COVID-19 at least 14 days after the second vaccination
时间窗: Up to 1 year after first vaccination
Symptomatic, virologically confirmed COVID-19 as described in the study
Incidence of severe solicited adverse events (AEs)
时间窗: Up to 7 days after each vaccination
Percentage of subjects reporting grade 3 or higher AEs after each vaccination
Incidence of SAE, and Adverse events of special interest (AESIs), which relevant to COVID-19 including possible vaccine-enhanced disease
时间窗: Up to 1 year after first vaccination
SAE and AESIs reported in all subjects at any time after the first vaccination
Incidence of AEs and Serious AEs (SAEs) after each vaccination
时间窗: Up to 1 month after each vaccination
Percentage of subjects reporting AEs and SAEs after each vaccination
次要结局
- First occurrence of severe COVID-19 at least 14 days after the second vaccination(Up to 1 year after first vaccination)
- Antibody responses after vaccination(Up to 1 year after first vaccination)
- Cell-mediated immune responses after vaccination(Up to 1 year after first vaccination)
研究者
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