ACTRN12621001159842招募中1 期
A Phase I/IIa Trial to determine safety of EDV nanocells packaged with a plasmid encoding SARS-CoV-2 spike protein in the EDV and a glycolipid a-galactosyl ceramide (EDV-plasmid-spike-GC) in non-COVID-19 infected volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Volunteers (male or female) non-COVID-19 infected.
- •2.Aged greater than or equal to 18 years.
- •3.No medical history of SARS-CoV-2 infection within 4 months of Day 1.
- •4.The subject (or subject’s legally authorised representative) has provided voluntary signed informed consent.
- •5.Subject should be willing to comply with protocol scheduled study visits or procedures, to the best of the subject and Investigator’s knowledge.
- •6.Have a baseline body temperature of less than or equal to 37·5°C and have general good health as established by medical history and physical examination.
- •7.Reproductive criteria as follows:
- •Female subjects who are of non-reproductive potential (i.e., post menopausal by history - no menses for greater than or equal to 1 year and follicle-stimulating hormone (FSH) level consistent with post-menopausal status; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
- •Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of the first dose.
- •Female subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration. Highly effective methods of birth control include sexual abstinence, hormonal birth control, or intrauterine device (women), vasectomy or a condom with spermicide (men) in combination with barrier methods.
- •Male subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration.
- •All study subjects must be willing to ensure that corresponding sexual partners practice these same methods of highly effective birth control for the same duration.
排除标准
- •1.Prior intervention for SARS-CoV-2 prophylaxis within 4 months of Day 1.
- •2.Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma within 4 months of Day 1.
- •3.Significant pericardial effusions, pleural effusions or ascites.
- •4.Subject has experienced a history of coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg), or cardiac arrhythmias requiring anti-arrhythmic therapy.
- •5.History of uncontrolled arterial or venous thrombosis. Subjects with a history of arterial or venous thrombosis are eligible if the subject is controlled via ongoing therapeutic intervention.
- •6.Active or uncontrolled severe infection.
- •7.Received the following procedures within 28 days prior to receiving their first dose (Day 1), (or has not recovered from the toxic effects of such therapy) including:
- •radiotherapy
- •major surgery.
- •8.History of myocarditis.
- •9.QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging considered as substitutes.
- •10.Known allergy/hypersensitivity to investigational components or excipients (monoclonal antibody infusions, interferon therapy or bacterial vaccines).
- •11.Any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
- •12.History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- •13.Platelet disorder or other bleeding disorder that may cause contraindication to injection.
- •14.Prior administration of other investigational agents less than or equal to 15 days prior to study Day 1.
- •15.Prior administration of attenuated vaccine in last 30 days.
- •16.Prior administration of inactivated vaccine in last 14 days.
研究者
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