用 P. Vivax 辐照子孢子免疫人类志愿者 (SPZ-Irrad)
1 期和 2a 期临床试验:用间日疟原虫辐照子孢子免疫人类志愿者
研究概览
详细说明
标题:1 期和 2a 期临床试验:使用间日疟原虫 irr-spz 对人类志愿者进行免疫接种。 (简称:Irrad-SPZ)群体 27 名年龄在 18-45 岁之间且符合纳入/排除标准(如下所述)的健康成年志愿者,包括男性和未怀孕女性,这些标准由临床病史和血清学测试确定。 在 8-10 个月期间,将需要大约 20 名被寄生虫感染的献血者志愿者来感染按蚊,这些蚊子将用于对总共 1000-1500 只受感染蚊子的志愿者进行免疫。 之后挑战证明保护。
站点数量:2 研究持续时间:2 年。 Subject Duration : 第一步:献血者1-2小时;第 2 步和第 3 步:免疫志愿者 2 年 目标 初级
• 评估间日疟原虫辐照子孢子疫苗接种的安全性和保护功效。
中学
- 与未免疫的人类志愿者相比,确定以前用 irr-spz 免疫的人类 Fy(+) 志愿者中间日疟原虫攻击引起的免疫反应和持续时间。
- 确定 irr-spz 免疫方案在人类 Fy(+) 志愿者中引起的免疫反应和持续时间;将其与 Fy(-) 参与者中非 irr-spz 的相同免疫方案进行比较,并将其与暴露于与免疫相同的蚊虫叮咬方案但使用没有寄生虫感染的蚊子的对照进行比较。
- 研究可能有助于诱导前红细胞保护以防止间日疟原虫疟疾感染的新抗原
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Valle
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Cali、Valle、哥伦比亚
- Malaria Vaccine of Develepmente Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
• 18 至45 岁的健康男性或未怀孕的女性。
- 有能力以自由和自愿的方式签署知情同意书。
- 通过批准关于同意过程中提供的信息的问卷调查,对临床试验有一个可接受的理解。
- 从招募开始和筛选时间到最后一次免疫后三个月,必须使用适当的避孕方法
- 没有慢性或急性疾病。 这些情况将通过临床病史、身体检查和实验室测试来确定。
- 接受在临床试验期间不去疟疾流行区旅行应该
- 在家里有电话或移动电话,可以进行永久联系以进行跟进
- 他(她)在临床试验的两个步骤中都表明愿意参与。
排除标准:
- 18岁以下或45岁以上的志愿者。
- 孕妇和哺乳期妇女将被排除在外。 怀孕将通过访谈和血清 B 亚基绒毛膜促性腺激素测试来确定。
- 中度或重度昆虫或食物过敏史。
- G-6PD 缺陷或任何 Hb 遗传缺陷(例如;镰状细胞病)
- 涂片、PCR 或特异性抗疟疾抗体证明以前感染过疟疾。
- 如果受试者以前参加过疟疾疫苗试验。
- 对药物或昆虫叮咬过敏的临床记录。
- 实验室测试的症状、体征或数据向医生提示任何全身性疾病,如肾脏、肝脏、心血管、肺部、精神疾病或其他可能干扰临床试验结果或可能损害志愿者健康的疾病。
- 具有针对丙型肝炎、VIH 或乙型肝炎表面抗原和/或乙型肝炎核心抗体的抗体。
- 通过血液实验室测试评估的参数有任何异常。 基线值将在临床试验开始前确定。
- 自身免疫性疾病的存在或病史,例如;哮喘、狼疮、类风湿性关节炎、格雷夫斯病、桥本甲状腺炎等。
- 手术切除脾脏(脾切除术)的历史。
- 在招募前 3 个月自愿接受已知会改变免疫系统的药物治疗,例如;皮质类固醇、化疗药物、氟达拉滨、环孢菌素、他克莫司、霉酚酸酯、雷帕霉素、ATG、阿仑单抗。
- 酗酒或滥用药物可能会干扰个人的社会关系。
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:风云(+)
实验组中的 14 名 Fy(+) 人类志愿者将接受 1,000-2,000 次间日疟原虫 irrad-spz 叮咬的免疫
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使用来自间日疟原虫感染供体的血液进行人工膜喂养,将感染白按蚊蚊子。 一旦蚊子呈阳性,将以 15000 cGy 照射并保存在盒子中直至使用。 实验组中的 14 名 Fy(+) 人类志愿者将接受 1,000-2,000 次间日疟原虫 irrad-spz 叮咬的免疫。 对照组中的七名 Fy(+) 志愿者将暴露于未感染的蚊子叮咬。 六名 Fy(-) 志愿者将暴露于感染性蚊虫叮咬。 对于攻击,免疫组和对照组都将暴露于 3±1 次感染性蚊虫叮咬。 志愿者将在感染后受到密切监测,并将接受抗疟药治疗。
其他名称:
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有源比较器:Fy(+) 对照
对照组中的七名 Fy(+) 志愿者将暴露于未感染的蚊子叮咬。
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使用来自间日疟原虫感染供体的血液进行人工膜喂养,将感染白按蚊蚊子。 一旦蚊子呈阳性,将以 15000 cGy 照射并保存在盒子中直至使用。 实验组中的 14 名 Fy(+) 人类志愿者将接受 1,000-2,000 次间日疟原虫 irrad-spz 叮咬的免疫。 对照组中的七名 Fy(+) 志愿者将暴露于未感染的蚊子叮咬。 六名 Fy(-) 志愿者将暴露于感染性蚊虫叮咬。 对于攻击,免疫组和对照组都将暴露于 3±1 次感染性蚊虫叮咬。 志愿者将在感染后受到密切监测,并将接受抗疟药治疗。
其他名称:
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有源比较器:风云(-)
六名 Fy(-) 志愿者将暴露于感染性蚊虫叮咬。
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使用来自间日疟原虫感染供体的血液进行人工膜喂养,将感染白按蚊蚊子。 一旦蚊子呈阳性,将以 15000 cGy 照射并保存在盒子中直至使用。 实验组中的 14 名 Fy(+) 人类志愿者将接受 1,000-2,000 次间日疟原虫 irrad-spz 叮咬的免疫。 对照组中的七名 Fy(+) 志愿者将暴露于未感染的蚊子叮咬。 六名 Fy(-) 志愿者将暴露于感染性蚊虫叮咬。 对于攻击,免疫组和对照组都将暴露于 3±1 次感染性蚊虫叮咬。 志愿者将在感染后受到密切监测,并将接受抗疟药治疗。
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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三个组被认为是被干预的。实验、控制和 Fy(-) 组。将在 E 组和 C 组之间进行保护功效比较。对于免疫反应测试 E vs Fy(-)、E vs Fy(-) 和 Fy(-) vs C,将比较配对。
大体时间:2年
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2年
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次要结果测量
结果测量 |
大体时间 |
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报告任何 AE 的受试者数量、特定 AE 的发生和因 AE 导致的中止将被制成表格。 AE 的频率将按组对每个免疫会话进行交叉制表
大体时间:2年
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2年
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合作者和调查者
调查人员
- 首席研究员:Socrates Herrera, MD、Malaria Vaccine Develepment Center
出版物和有用的链接
一般刊物
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