NCT02820883已完成早期 1 期
A Single-center, Dose-escalation, Open-label Pilot Study to Evaluate the Safety and Tolerability of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults Aged 18-65 Years in China
Jiangsu Province Centers for Disease Control and Prevention1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年6月最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Occurrence of solicited adverse reactions after vaccination.
研究概览
简要总结
This is an open-label, dose-escalation pilot study with a total of 30 participants with 10 per dosage group. The aim of the pilot study is to explore the preliminary safety of an experimental recombinant staphylococcus aureus vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy volunteers aged 18 to 65 years (aged over 18 and under 66 years).
- •Able to comply with all clinical trial protocol requirements and willing to complete all the visit plan process during the whole clinical trial observation period.
- •Able to understand the content of informed consent and willing to sign the informed consent.
- •Able to complete the diary card independently.
- •For females only (18-49 years), a negative urine pregnancy test and willing to practice continuous effective contraception during the study.
- •Axillary temperature ≤37.0°C.
排除标准
- •First Immunization exclusion standard:
- •Prior receipt of Staphylococcus aureus vaccine
- •Any confirmed Staphylococcus aureus infection disease in the past 12 month.
- •History of asthma, hereditary angioneurotic edema, diabetes, malignancy or other serious disease. Participation in the clinical trial is likely to increase the disease risk and interfere with the observation of clinical trial index.
- •Prior blood donation or Blood loss over 400ml in the last 3 months;
- •Coagulation disorders (coagulation factor deficiency, coagulopathy or platelet disorder) diagnosed by doctors, or obvious bruises or blood coagulation noticed.
- •History of allergic disease likely to be exacerbated by any component of the vaccine, including allergy, urticaria, respiratory difficulty, angioneurotic edema or abdominal pain.
- •Any autoimmune disease or immunodeficient state, parents, brother and sister with autoimmune disease or immunodeficient disease.
- •Taking immunoglobulins and/or any blood products within the last 12 months.
- •Asplenia, functional asplenia or asplenia caused by any situation or splenectomy.
- •Any acute disease or acute attack of chronic disease in last 7 days.
- •History of thyroidectomy or thyroid disease requiring treatment in the last 12 months.
- •Immunosuppressor, cytotoxic therapy, inhaled corticosteroid (excluding corticosteroids spray treatment of allergic rhinitis, acute and non-concurrent corticosteroids treatment)
- •Participation in another research study involving receipt of an investigational product in the last 30 days.
- •Woman who is breast-feeding.
- •Prior administration of attenuated vaccine in last 28 days.
- •Prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days.
- •Current anti-tuberculosis prophylaxis or therapy
- •Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.
- •Following Immunization exclusion standard:
- •Any grade 3 or more serious adverse reaction happen since the last vaccination.
- •Other condition violates the inclusion criteria or meets the exclusion criteria is noticed after the first immunization.
- •Acute or chronic infections at the vaccination day (axillary temperature>37.0°C).
- •According to the investigator, the participant should not continue participating in the study.
结局指标
主要结局
Occurrence of solicited adverse reactions after vaccination.
时间窗: within 0-14 days after the vaccination
Occurrence of solicited site adverse reactions within 0-14 days after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli).
次要结局
- Occurrence of unsolicited adverse reactions after vaccination.(within 0-35 days after the vaccination)
- Occurrence of serious adverse events after the vaccination.(within 6 months after the vaccination)
- Changes of the laboratory examinations after vaccination.(day 10 after the vaccination)
研究者
Fengcai Zhu
Professor
Jiangsu Province Centers for Disease Control and Prevention
研究点 (1)
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