Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71
2015年5月5日 更新者：Inviragen Inc.
Phase I, Double Blind, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety and Immunogenicity of a Prophylactic Vaccine Against Enterovirus Infection in Healthy Adults
The purpose of this study is to evaluate the safety and immune response of an inactivated vaccine to prevent hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71).
研究概览
详细说明
Hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71) can be severely debilitating for some children with a risk of paralysis and death.
The most susceptible age group is the 1 to 5 year olds, and the disease is spread via the oral-fecal route.
Currently, there is no antiviral therapy nor there is a vaccine available to prevent HFMD.
In this study, an inactivated vaccine (INV21) based on the EV71 antigen will be evaluated in terms of safety and immune response that is generated after two doses of the vaccine are given to healthy adults.
Safety assessments include the frequency and severity of systemic adverse events as well as local reactions.
Immune response will be assessed by measurement of EV71 neutralizing antibody levels at specified time points throughout the study.
研究类型
介入性
注册 (实际的)
36
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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Singapore、新加坡、119074
- Investigational Medicine Unit, National University Hospital
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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
21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:
- Male or female aged 21 to 45 years, inclusive, at time of screening
- In good health as determined by medical history and physical examination.
- Normal clinical safety laboratory examinations.
- Body mass index (BMI) in the range 19-28 kg/m2.
- Documented negative serology for HIV, Hepatitis C antibody, and Hepatitis B surface antigen.
- Females of child bearing potential must have a negative urine pregnancy test result during screening and a negative urine pregnancy test immediately prior to vaccination.
- Willing and able to give written informed consent to participate.
- Willing and able to communicate with the Investigator and understand the requirements of the study.
- Low levels of EV71 neutralizing antibody.
Exclusion Criteria:
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
- Clinically significant hematological (including bleeding disorders), renal, hepatic, pulmonary (including asthma), central nervous system (including epilepsy, seizures, convulsions, or chronic migraines), cardiovascular, or gastrointestinal disorders, according to Investigator's judgment.
- Ongoing rash or other dermatologic disease.
- Abnormal ECG as assessed by the Investigator.
- History of diabetes mellitus.
- Hypersensitivity to any vaccine.
- History of severe HFMD with CNS involvement.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study.
- History of thymic pathology, thymectomy, myasthenia or any immunodeficiency.
- History of recurring migraines or on prescription medication for treatment of recurring headaches or migraines.
- Positive urine test for drugs of abuse.
- Females who are pregnant or lactating
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：INV21 Low Dose
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磷酸盐缓冲盐水 (PBS)
Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide.
其他名称：
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实验性的：INV21 High Dose
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磷酸盐缓冲盐水 (PBS)
Inactivated EV71 vaccine consisting of whole viral particles of EV71 formulated with aluminum hydroxide.
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 |
措施说明 |
大体时间 |
|---|---|---|
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Frequency of systemic adverse events and local reactions in healthy adults following two doses of INV21 given 28 days apart
大体时间：56 days
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Frequency and severity of systemic adverse events up to 56 days post first dose.
Frequency and severity of local reactions up to 14 days post each dose.
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56 days
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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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Immunogenicity of INV21 vaccine in healthy adults following two doses given 28 days apart
大体时间：8 months
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Geometric mean titers based on neutralizing antibody titers.
Measurement of fold-increase over baseline of neutralizing titers against EV71.
Durability of immune response at 2 months and 6 months after the last dose.
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8 months
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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。
调查人员
- 首席研究员：Paul A Tambyah, MBBS、Department of Medicine, National University Hospital
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
2011年8月1日
初级完成 (实际的)
2011年11月1日
研究完成 (实际的)
2012年4月1日
研究注册日期
首次提交
2011年6月16日
首先提交符合 QC 标准的
2011年6月17日
首次发布 (估计)
2011年6月20日
研究记录更新
最后更新发布 (估计)
2015年5月6日
上次提交的符合 QC 标准的更新
2015年5月5日
最后验证
2015年5月1日
更多信息
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.