NCT04915989已完成1 期
A Phase 1, Multicenter, Open-Label, Single Arm Study to Investigate the Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of Serious Adverse Event(SAE)s
研究概览
简要总结
The objective of the study is to demonstrate safety and immunogenicity of COVID-19 preventive DNA vaccine in elderly individuals.
详细描述
This clinical study is a phase 1 clinical trial to investigate the safety and immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in the elderly.
This study is designed as single arm, open-labeled and a total of 30 subjects will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to comply with all study procedures and voluntarily signs informed consent form
- •Male or female aged 55-85 years
- •Willing to provide specimens such as blood and urine during the study, including end of study visit.
排除标准
- •Immunosuppression including immunodeficiency disease or family history Any history of malignant disease within the past 5 years
- •Scheduled to undergo any surgery or dental treatment during the study
- •Having received immunoglobulin or blood-derived drugs or being expected to be administered within 3 months prior to administration.
- •Having relied on antipsychotic drugs and narcotic analgesics within 6 months before administration
- •Positive of serology test at screening
- •Suspected of drug abuse or a history within 12 months prior to administration
- •Active alcohol use or history of alcohol abuse
- •Serious adverse reaction to a drug containing GX-19N or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history
- •History of hypersensitivity to vaccination such as Guillain-Barre syndrome
- •Those with significant chronic underlying diseases that may increase the risk of COVID-19 or interfere with the evaluation of clinical trial purposes according to the investigator's discretion
- •Having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants
- •Subjects who have been contact with COVID-19 infections in the past prior to administration, have been classified as COVID-19 confirmed patients, medical patients or patients with symptoms or have been identified with SARS and MERS infection history in the past
- •Acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration
- •Other vaccination history within 28 days prior to the administration or being scheduled to be inoculated during the study
- •History of having taken immunosuppressant or Immune modifying drug within 3 months prior to administration
- •Having participated and had clinical trial drug administration in another clinical trial or biological equivalence study within 6 months prior to the administration
- •Pregnant or breastfeeding female, however, those are allowed to participate in the study only if they stop breastfeeding before participation (fertile female† must be negative in serum pregnancy test at screening
- •Fertile female who do not agree to use effective contraception methods (condoms, contraceptive diaphragm, intrauterine contraceptive devices) during the study
- •Any other clinically significant medical or psychiatric finding which is considered inappropriate by investigator
研究组 & 干预措施
GX-19N
Experimental
Dose A of GX-19N will be intramuscularly administered via Electroporator(EP) on day 1 and day 29. (Optional administration on day 57)
干预措施: GX-19N (Drug)
结局指标
主要结局
Incidence of Serious Adverse Event(SAE)s
时间窗: Through 1 year post vaccination
percentage of subjects with SAEs
Incidence of Solicited Adverse Event(AE)s
时间窗: Through 1 year post vaccination
solicited local and systemic AEs after vaccination
Incidence of Unsolicited Adverse Events
时间窗: Through 1 year post vaccination
unsolicited AEs after vaccination
次要结局
- Percentage of Subjects Who Seroconverted After Vaccination(Through 12 weeks after vaccination)
- GMFR of Antigen-specific Binding Antibody Titers(Through 12 weeks after vaccination)
- GMT of Antigen-specific Binding Antibody Titers(Through 12 weeks after vaccination)
- GMFR of Neutralizing Antibody Level(Through 12 weeks after vaccination)
- GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay(Through 12 weeks after vaccination)
- GMT of Neutralizing Antibody Level(Through 12 weeks after vaccination)
- GMSN of Spot Forming Unit (SFU) detected by interferon(IFN)-gamma ELISPOT assay(Through 12 weeks after vaccination)
研究者
研究点 (2)
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