NCT04863131已完成1 期
Safety and Immunogenicity of Intradermal SARS-CoV-2 Vaccine EXG-5003 in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting Local and Systemic Adverse Events
研究概览
简要总结
This is a First in Human, randomized, placebo-controlled Phase I/II trial to evaluate the safety and immunogenicity of the intradermal COVID-19 vaccine, EXG-5003 in healthy adults.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has provided written consent for participation
- •Age between 20 and 55
- •Has a negative nucleic acid-based test result for SARS-CoV-2
- •Has a negative antibody test result for SARS-CoV-2
排除标准
- •Signs and symptoms consistent with COVID-19 upon screening
- •History of COVID-19
- •Presence of uncontrolled cardiovascular, hematologic, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disease
- •Presence of diabetes mellitus
- •Presence of active autoimmune disease
- •Positive for HBc, HCV or HIV antibody
- •History of anaphylactic shock
- •History of epilepsy
- •Presence of active malignancy
- •Presence of lung disease (e.g., COPD, asthma)
- •Positive urine pregnancy test within 24 hours
- •Pregnant, lactating, planned pregnancy of self (if female) or partner (if male) within 90 days after administration of the trial drug
- •If female and premenopausal, not agreeable to contraception for 90 days after second administration of the trial drug
- •If male, not agreeable to contraception for 90 days after second administration of the trial drug
- •Presence of clinically relevant electrocardiogram or vital sign abnormality at screening
- •Participated in a clinical trial of a drug or a medical device within 30 days or a biologic within 90 days
- •Received any SARS-CoV-2 vaccine
- •Received within 90 days, or is planning to receive during the study period, an immunoglobulin or blood product
- •Received within 180 days, or is planning to receive during the study period, a biologic product with immunosuppressive properties
- •Received for 14 days or more within 180 days, or is planning to receive during the study period, a corticosteroid
- •Deemed ineligible for the study as determined by the principal investigator or a co-investigator
结局指标
主要结局
Number of Participants Reporting Local and Systemic Adverse Events
时间窗: Day 1 up to Day 365 post dose
次要结局
- GMT of neutralizing antibody(Day15, Day29, Day43, Day57, Day92, Day183, Day365)
- Flowcytometry assay to enumerate the frequency of T cells expressing CD3, CD4, CD8, CD62L, CD45RA, IFN-γ, IL-4, CD107, TNF, IL-2, IL-6, CD154 (CD40L), Perforin, and Granzyme B.(Day15, Day29, Day43, Day57, Day92, Day183, Day365)
- Assessment of T cells by Intracellular cytokine staining assays(Day15, Day29, Day57,)
- Genometric Mean Titer (GMT) of serum anti-RBD IgG(Day15, Day29, Day43, Day57, Day92, Day183, Day365)
研究者
Yohei Doi
Professor and Chair of the Department of Microbiology
Fujita Health University
研究点 (1)
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