Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector
2019年7月16日 更新者：Takeda
Phase 1b, Partial-Blind, Parallel Group, Randomized Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine (DENVax) Administered Intradermally Using Needle or a Needle-Free PharmaJet® Injector in Healthy Adults
The purpose of this study is to compare the safety, tolerability and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] when administered intradermally in varied dosing schedules and via different methods of administration (conventional needle/syringe versus needle-free PharmaJet® injector).
研究概览
详细说明
This is an exploratory trial to assess the safety, tolerability and immunogenicity of vaccination with a tetravalent dengue vaccine (TDV) in healthy adults delivered intradermally using the conventional needle/syringe or a needle-free PharmaJet® injector.
Two (2) intradermal injections of either vaccine or placebo will be administered to qualified participants (one in each arm) on Day 0 of the study. A subsequent injection will also be given on Day 90 with either vaccine or placebo (in one arm only).
Participants will be evaluated for safety and dengue neutralizing antibody to all four serotypes. All participants will also be evaluated for injection site reactions and have blood drawn for viremia, neutralizing antibodies, cell mediated immunity and innate immunity.
Participants will be required to participate for approximately 10 months from recruitment and collection of data for primary outcomes (through Day 120) including collection of additional samples for measurement of longer term antibody titers (through Day 270).
This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201000034C.
研究类型
介入性
注册 (实际的)
67
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Texas
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Galveston、Texas、美国、77555
- University of Texas Medical Branch
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Washington
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Seattle、Washington、美国、98101
- Group Health Research Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 45年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- In good health as determined by medical history and physical examination (including blood pressure and heart rate).
- Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies & Hepatitis B surface antigen.
- Females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception.
- Body Mass Index (BMI) ≤ 35 kg/m^2.
Exclusion Criteria:
- Any Grade 2 or above abnormality in the screening laboratory tests.
- History of Dengue Fever, Japanese Encephalitis, West Nile or Yellow Fever disease.
- Seropositivity to dengue or West Nile virus.
- Extensive scarring or tattoo (> 50%) on arms, shoulders, neck face and head.
- History of significant dermatologic disease in the last 6 months.
- Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the Day 0 or 90 vaccinations.
- Any planned travel to dengue endemic areas including the Caribbean, Mexico, Central America, South America or Southeast Asia, during the study period and during the month prior to screening.
- Use of systemic corticosteroids therapy within the previous 6 months (at a dose of 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or used within the last month prior to the first vaccination.
- Use of any prescribed medication 7 days before the first injection.
- Previous vaccination in a clinical study or with an approved product against Dengue Fever, Yellow Fever and or Japanese Encephalitis.
- Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy in the last 6 months.
- Planned donation of blood during the period of the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Group 1: TDV using PharmaJet® Injector
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
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TDV suspension for intradermal administration
Phosphate buffered saline (PBS)
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实验性的：Group 2: TDV using PharmaJet® Injector
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
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TDV suspension for intradermal administration
Phosphate buffered saline (PBS)
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实验性的：Group 3: TDV using Needle and Syringe
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
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TDV suspension for intradermal administration
Phosphate buffered saline (PBS)
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实验性的：Group 4: TDV using PharmaJet® Injector
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
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TDV suspension for intradermal administration
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
大体时间：28 Days after each dose
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An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment.
Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching).
Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=<15 millimeters (mm), 2=15 to 30 mm and 3=>30 mm (severe).
Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization.
Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade.
Only categories for which there was at least 1 participant are reported.
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28 Days after each dose
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Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity
大体时间：28 Days after each dose
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An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment.
AEs are graded from Grade 0=None to Grade 4=Life threatening.
AEs are presented as the percentage of participants experiencing an AE, overall and by severity, using the participant's worst reported severity grade.
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28 Days after each dose
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Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
大体时间：14 days after each dose
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An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment.
Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting.
Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening.
Systemic reactions are presented as percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade.
Only categories for which there was at least 1 participant are reported.
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14 days after each dose
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Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
大体时间：14 days after each dose
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An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment.
Local injection site AEs solicited from the participant using a memory aid included: erythema (redness), edema/induration (swelling), pain and pruritus (itching).
Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade.
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14 days after each dose
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Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity
大体时间：28 Days after each dose
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An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment.
AEs are graded from Grade 0=None to Grade 4=Life threatening.
AEs are presented as the percentage of participants experiencing an AE causally related to the study treatment as assessed by the investigator, overall and by severity, using the participant's worst reported severity grade.
Only categories for which there was at least 1 participant are reported.
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28 Days after each dose
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Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)
大体时间：118 Days
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The percentage of participants with any clinically relevant abnormal safety laboratory values (chemistry, hematology and urinalysis) collected from vaccine dose 1 (Day 0) through 28 days after dose 2 (Day 90) that were reported as AEs. Abnormal laboratory values were reported as AEs based on the following criteria: Grade 3 (Severe) or Grade 4 (Life threatening) laboratory abnormalities based on DMID toxicity tables or laboratory abnormalities which resulted in a medical intervention. |
118 Days
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Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection
大体时间：Day 28
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Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
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Day 28
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Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection
大体时间：Day 118
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Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
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Day 118
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Percentage of Participants With Unsolicited Vaccine-Related SAEs
大体时间：Dose 1 until 28 days after Dose 2 (Up to Day 118)
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A serious adverse event (SAE) is any AE in the view of the investigator that results in any of the following outcomes: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that may require medical or surgical intervention to prevent one of the other serious outcomes.
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Dose 1 until 28 days after Dose 2 (Up to Day 118)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
大体时间：Days 0, 28, 90, 118 and 270
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Days 0, 28, 90, 118 and 270
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Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270
大体时间：Days 90 and 270
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Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
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Days 90 and 270
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Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination
大体时间：Day 0 to Day 104
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A quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay was used for detection and serotype identification of dengue viral ribonucleic acid (RNA) that is present in serum.
A test for viremia is considered positive if the assay value is >= 3.6, which is the limit of quantification (LOQ), negative if the assay value was zero, and undetermined if the assay value is >0 but <3.6.
The percentage of participants with positive results is reported.
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Day 0 to Day 104
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年2月15日
初级完成 (实际的)
2014年6月26日
研究完成 (实际的)
2014年6月26日
研究注册日期
首次提交
2012年12月17日
首先提交符合 QC 标准的
2013年1月8日
首次发布 (估计)
2013年1月10日
研究记录更新
最后更新发布 (实际的)
2019年7月18日
上次提交的符合 QC 标准的更新
2019年7月16日
最后验证
2019年7月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 11-0049
- U1111-1178-6503 (注册表标识符：WHO)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.