NCT04463472已完成1 期
A Non-randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Two Doses of Intramuscular AG0301-COVID19 (1mg/2mg) in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AnGes, Inc.
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Immunogenicity
研究概览
简要总结
This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.
详细描述
This is a Phase 1/2, single-center, non-randomised, open-label, non-controlled trial. Approximately 30 healthy volunteers, male or female, aged 20-65, will be enrolled in the low dose group for the first 15 and the high dose group for the remaining 15.
Low dose group: 1.0 mg AG0301-COVID19 intramuscular (IM) (n = 15) High dose group: 2.0 mg AG0301-COVID19 IM (n = 15)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have obtained written consent voluntarily to participate in this clinical trial
- •Subjects whose age at the time of obtaining consent is 20 years to 65 years
- •Subjects who are negative for SARS-CoV-2 by PCR test
- •Subjects who are negative for both SARS-CoV-2 IgM antibody and SARS-CoV-2 IgG antibody by antibody test
排除标准
- •Subjects with symptoms of suspected COVID-19 infection (respiratory symptoms, headache, malaise, olfactory disorders, taste disorders, etc.)
- •Subjects with a history of COVID-19 (hearing from subjects)
- •Subjects who have participated in unapproved vaccine clinical trials
- •Subjects with axillary temperature of 37.0 degree or higher
- •Subjects who have a history of anaphylaxis
- •Subjects who have serious renal, liquid, respiratory, liver, kidney, digestive, and neuropsychiatric history has a current medical history
- •Subjects with a history of convulsion or epilepsy
- •Subjects with a history of diagnosis of immunodeficiency
- •Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
- •Subjects who have a history of bronchial asthma
- •Subjects who had a fever of 39.0°C or higher within 2 days after the last vaccination, and those who suspected allergy such as a systemic rash
- •Females who wish to become pregnant from the date of study registration to 12 weeks after the first inoculation of the investigational drug, and pregnant females who are breast-feeding. In addition, females who may become pregnant and their male sexual partners should use appropriate contraceptives (pill), condoms, vasectomy, tubal ligation, diaphragm, intrauterine devices, spermicides, intrauterine hormone-releasing system, etc. from the study entry date until 12 weeks after vaccination
- •Subjects who have participated in clinical trials of other unapproved drugs and received the investigational drug within 4 weeks before the start of this clinical trial (starting from vaccination day)
- •Subjects who have been received a live vaccine, inactivated vaccine, or toxoid within 4 weeks before the start of this clinical trial (starting from vaccination day)
- •Subjects who have been administered with drugs that affect the immune system (excluding external preparations) such as immunomodulators (DMARDs, etc.), immunosuppressants, biologics, etc. within 4 weeks from vaccination
- •Subjects who received blood transfusion or gamma globulin therapy within 12 week before vaccination, or high-dose gamma globulin therapy (200 mg/kg or more) within 24 weeks before vaccination
- •Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
- •Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)
- •Subjects who are judged to be ineligible for this clinical trial by the investigator
结局指标
主要结局
Immunogenicity
时间窗: Weeks 3, 5, 7, 9
Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Week 1 through Week 9
Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after first vaccination
次要结局
- Change in GMT of anti-SARS-CoV-2 B cell epitope antibody(Weeks 3, 5, 7, 9, 13, 25, 53)
- Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody(Weeks 3, 5, 7, 9, 13, 25, 53)
- Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody(Weeks 13, 25, 53)
- Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody(Weeks 3, 5, 7, 9, 13, 25, 53)
- Adverse events(Week 9 through Week 53)
研究者
研究点 (1)
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