Characterisation of Dengue Vaccine (Qdenga®, TAK-003)-Induced Humoral and Cellular Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Anti-DENV antibodies
研究概览
简要总结
The goal of this observational study is to learn about the immunity induced by the Qdenga® vaccine in vaccinees.
Participants that will receive the Dengue vaccine as part of their routine before a travel will be asked to undergo a blood sample at the time of administration of the first dose (T0), 24-48 hours after the first dose (T1) of the vaccine, immediately before the second dose (T2 ) and one to two months after the second dose (T3). Possibly a further sample will be collected within 2 years.
详细描述
This is a non-profit, single-center, drug-based observational study whose primary objective is to characterize dengue-specific humoral and cellular immunity induced by the Qdenga® vaccine in vaccinees.
The study involves the enrollment of all pediatric subjects (age ≥ 4 years) and adults who present themselves at the DITM travel clinic for the administration of the Dengue vaccine; 402 patients are expected to be enrolled and will be asked to undergo a blood sample at the time of administration of the first dose (T0), 24-48 hours after the first dose (T1) of the vaccine, immediately before the second dose (T2 ) and one to two months after the second dose (T3). Possibly a further sample will be collected within 2 years (T4). The samples thus collected will be analyzed for the characterization of innate immunity, the characterization of cellular immunity and the characterization of the humoral response.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of both sexes presenting to the DITM to receive the anti-DENV vaccine whether or not they have had a history of prior DENV or other flaviviruses infection or a history of prior vaccination against other flaviviruses. These data will be recorded in the study CRF.
- •Age >= 4 years.
- •Signed informed consent.
排除标准
- •Age < 4 years.
- •Absence of signed informed consent.
研究组 & 干预措施
Patients
All pediatric and adult subjects attending the travel clinic of the DITM for the administration of Dengue vaccine.
干预措施: Qdenga (Drug)
结局指标
主要结局
Anti-DENV antibodies
时间窗: BEFORE administration of the first dose (Time 0 = T0), immediately BEFORE the second dose (Time 2 = T2) of vaccine, and one to two months after the second dose (Time 3 = T3)
Anti-DENV antibodies quantities (IgG and IgM, continuous variables unity of measure: Antibody titre dilution) BEFORE administration of the first dose (T0), immediately BEFORE the second dose (T2) of vaccine, and one to two months after the second dose (T3)
次要结局
- Innate immunity response(BEFORE administration of the first dose (T0), after 24-48h after the first dose (Time 1 = T1))
- Cellular response(At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3))
- Quantitative and qualitative anti-DENV antibody response(At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3))
- Humoral response(At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3))
- Cell mediated response(At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3))