NCT02948829已完成2 期
An Open Label, Phase 2 Study to Investigate Cell-mediated Immunity and Safety of a Tetravalent Dengue Vaccine Candidate (TDV) Administered Subcutaneously in Healthy Children Aged 4 to 16 Years
Takeda4 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2017年4月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination
研究概览
简要总结
The purpose of this study is to assess the cellular immune responses following 2 doses given 3 months apart of tetravalent dengue vaccine candidate (TDV) in 4 to 16 years' healthy participants.
详细描述
The vaccine tested in this study was TDV. This study assessed cellular immune responses and safety up to 3 years post second TDV administration to healthy children aged 4 to 16 years and in dengue endemic regions.
The study enrolled 200 participants. Participants received:
• TDV 0.5 mL subcutaneous (SC) injection into the upper arm at Day 1 (Month 0) and at Day 90 (Month 3).
This multi-center trial was conducted in Panama and Philippines. 198 participants received the 2-dose schedule of TDV, and 2 participants received only the first dose of TDV (Day 1). Participants made multiple visits to the clinic and were contacted at least every week for the entire study duration post first injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Is aged 4 to 16 years, inclusive (Latin America) or 4 to 8 years, inclusive (Asia).
- •Are in good health at the time of entry into the study as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator.
排除标准
- •Febrile illness (body temperature ≥38°C) or moderate or severe acute illness or infection at the time of enrolment.
- •History or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose an additional risk to the participant due to participation in the study.
- •Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccines within 28 days after Day 1 (Month 0).
- •Previous participation in any clinical study of a dengue candidate vaccine, or previous receipt of any dengue vaccines (investigational or licensed).
研究组 & 干预措施
Tetravalent Dengue Vaccine (TDV) 0.5 mL
Experimental
TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3).
干预措施: TDV (Biological)
结局指标
主要结局
Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination
时间窗: 1 month post second vaccination (Day 120)
Percentage of participants with cellular immune response were reported. Cellular immune response was defined as an interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) response that was \>3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included non-structural proteins (NS) NS3 and NS5 for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4 and NS1 for DENV-2. Percentage of participants with cellular immune response were reported. Percentages are rounded off to the nearest decimal point.
次要结局
- Percentage of Participants Seropositive for Multiple Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, 1, 6 Months Post Second Vaccination and Annually up to 3 Years(1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3))
- Magnitude of Cellular Immune Response Assessed by Number of Spot Forming Cells (SFC)/Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by IFN-γ ELISPOT at 1 Month Post Second Vaccination(1 month post second vaccination (Day 120))
- Percentage of Participants With Cellular Immune Responses to TDV at 1 Month Post First Vaccination, Pre-second Vaccination, 1 and 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3 Assessed by Country(1 month post first vaccination (Day 30); pre-second vaccination (Day 90) 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, 3)
- Percentage of Participants With Cellular Immune Responses to TDV:1 Month Post First Vaccination, Pre-second Vaccination, 1 and 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3, by Dengue Baseline Seropositivity Status(1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3)
- Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First, Pre- Second Vaccination, 1 and 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3 by Country(1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3)
- Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT in Participants >10 Years of Age(Day 14)
- Phenotype Characterization of Cellular Immune Response by Percentage of Total T Cells DENV-2 NS Peptides at 1Month Post First Vaccination,Pre Second Vaccination;1,6Months Post Second Vaccination,Annually at Years1,2,3 by Dengue Baseline Seropositivity(1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3)
- Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First Vaccination, Pre-second Vaccination, 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3(1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 6 months post second vaccination (Days 120 and 270); Years 1, 2 and 3)
- Percentage of Participants With Cellular Immune Response to TDV in Participants >10 Years of Age(Day 14)
- Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response to DENV-2 NS Peptides at 1Month Post First Vaccination,Pre-second Vaccination;1,6Months Post Second Vaccination, Annually at Years1,2,3(1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3)
- Percentage of Participants With Cellular Immune Response to TDV at 1 Month Post First Vaccination, Pre-second Vaccination, 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3(1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 6 months post second vaccination (Day 270); Years 1, 2 and 3)
- Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT 1Month Post First Vaccination,Pre-second Vaccination;1,6Months Post Second Vaccination, Annually at Years1,2,3 by Dengue Baseline Seropositivity Status(1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3)
- Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually Up to 3 Years(1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3))
- Percentage of Participants With Serious Adverse Events (SAEs)(From first vaccination (Day 1) up to end of study (Approximately 3 years))
- Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response DENV-2 NS Peptides,1Month Post First Vaccination,Pre Second Vaccination;1,6Months Post Second Vaccination,Annually at Years1,2,3 by Country(1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3)
- Percentage of Participants Experiencing Unsolicited Adverse Events (AE)(Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 [Month 0] and Day 90 [Month 3])
- Percentage of Participants With Medically Attended AEs (MAAEs)(From first vaccination (Day 1) up to 6 months post second vaccination (Day 270))
- Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre-second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually up to 3 Years(1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3))
- Percentage of Participants With Virologically Confirmed Dengue(From first vaccination (Day 1) up to 6 months post second vaccination (Day 270))
研究者
研究点 (4)
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