NCT04993586已完成1 期
A Randomized, Open-label, Uncontrolled, Phase I/II Study to Assess Safety and Immunogenicity of Two or Three Dosing of Intramuscular/Intradermal AG0302-COVID19
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
- 422
- 试验地点
- 12
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy volunteers.
详细描述
This is a Phase I/II, multi-center, randomized, open-label, uncontrolled trial. Approximately 400 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following five groups:
[IM Groups] Group A: Vaccination 2 mg, three times at 2-week intervals (n = 80) Group B: Vaccination 4 mg, twice at 4-week intervals (n = 80) Group C: Vaccination 8 mg, twice at 4-week intervals(n = 80)
[ID Groups] Group D: Vaccination 1 mg, three times at 2-week intervals (n = 80) Group E: Vaccination 1 mg, twice at 4-week intervals (n = 80)
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
- None
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
- •Subjects who have obtained written consent voluntarily to participate in this clinical trial
- •Subjects whose age at the time of obtaining consent is 18 years or older
- •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 with a history of vaccination for the prevention of COVID-19
- •Subjects who have participated in unapproved vaccine clinical trials within 1 year before the start of this study
- •Subjects with an axillary temperature of 37.5 degrees or higher at the time of screening
- •Subjects with an axillary temperature of 37.5 degrees or higher before the first vaccination
- •Subjects who have a history of anaphylaxis
- •Subjects who have a history of hypersensitivity to the ingredients of the investigational drug
- •Subjects who have a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases
- •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 current bronchial asthma
- •Subjects who have had a fever of 39.0 degrees or higher within 2 days after vaccination, or who have been suspected of having an allergy such as a systemic rash.
- •Females who wish to become pregnant from the time of obtaining consent to 12 weeks after the first vaccination, 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 the first 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 before vaccination
- •Subjects who received blood transfusion or gamma globulin therapy within 12 weeks 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
Incidence of Treatment-Emergent Adverse Events
时间窗: Week 1 through Week 13
Frequency and severity of each adverse event, solicited local and systemic AEs from the first vaccination to 12 weeks after first vaccination
Immunogenicity
时间窗: Week 13
Change in the neutralizing activity against pseudovirus of SARS-CoV-2 \[ID50\]
次要结局
- Change in the neutralizing activity against pseudovirus of SARS-CoV-2(Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53)
- Rate of SARS-CoV-2 positive and incidence rate of COVID-19 after the first vaccination(Week 1 through Week 53)
- IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody(Weeks 1, 9, 13)
- Rate of swelling and leakage of the drug to the vaccination site during intradermal vaccination(Weeks 1, 3, 5)
- Seroconversion rate from baseline (defined as a 4-fold or greater increase) in the neutralizing activity against pseudovirus of SARS-CoV-2 [ID50](Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53)
- Change in IFN-gamma production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells(Weeks 5, 7, 9, 13)
- Adverse events(Week 13 through Week 53)
- Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody(Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53)
- Number of defects in preparation and vaccination during intradermal vaccination(Week 1 through Week 5)
研究者
研究点 (12)
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