A Study Exploring Whooping Cough Protection in Children and Adults
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University of Oxford
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信息的提供 (责任方):
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | April 23, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | April 18, 2018 | ||
| 预计主要完成日期 | August 31, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Change from baseline of pertussis toxin-specific IgG antibody levels to 28 days after vaccination[ Time Frame: 28 days ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | A Study Exploring Whooping Cough Protection in Children and Adults | ||
| 正式标题 ICMJE | Immunological Effects of an Acellular Pertussis Booster Vaccination in Children, Young Adults and Elderly With Different Immunisation Background. An International Study in Finland, the Netherlands and the United Kingdom | ||
| 简要概况 | This study aims to investigate the effects of aP booster vaccination in children, young adults and elderly on the (long-term) immune response to B. pertussis in three European countries with a different epidemiological background and primary vaccination schedule for pertussis. |
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| 详细说明 | The study will be performed in three European countries (UK, Finland and the Netherlands) with a different epidemiological background for pertussis incidence and different age groups will have had different primary schedules with whole cell pertussis (wP) or aP vaccines in their first year of life. Long-term memory responses will be analysed following aP booster vaccination including a detailed assessment of antigen-specific B and T cell responses, serology assays for pertussis antigens and the effect of booster vaccination on dynamic changes in immune cell subsets and gene transcription. There will be four cohorts of healthy volunteers: Cohort A - children aged between 7-10 years Cohort B - children aged between 11-15 years Cohort C - adults aged between 20 to 34 years Cohort D - adults aged between 60-70 years Participants will receive one injection of reduced diphtheria toxoid, tetanus toxoid and reduced acellular pertussis vaccine (dTap)-IPV, (Boostrix® IPV, GlaxoSmithKline (GSK)) combination vaccine intramuscularly in the upper arm. Children (cohorts A and B) will be asked to donate blood four times at different time points, and young and older adults (cohorts C and D) will be asked to donate blood at set time points five times in total over the 12 months duration of the study. The time points will be: - Timepoint 0 - day of vaccination - Timepoint 1 - 1 day after T0 +/- 4 hours - Timepoint 2 - 7 days after T0 +/- 1 day - Timepoint 3 - 14 days after T0 +/- 4 days - Timepoint 4 - 28 days after T0 +/- 4 days - Timepoint 5 - 1 year after T0 +/- 4 weeks | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 4 | ||
| 研究设计 ICMJE | 分配: Non-Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Prevention |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
122 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | August 31, 2019 | ||
| 预计主要完成日期 | August 31, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Normal general health - Within the right age group for the cohort - Received all regular vaccines for their age group according to the Dutch NIP, UK NIP or Finnish NIP; a copy of the vaccination booklet will be included in the participant's documents. If booklet is not available for cohorts A, B and C, vaccination status will be checked although, for cohort C and D this booklet might not be available due to their age; - Provision of written informed consent - Willing to adhere to the protocol and be available during the study period. Exclusion Criteria: - Present evidence of serious disease(s) within the last 3 months before inclusion requiring immunosuppressive or immune modulating medical treatment, such as systemic corticosteroids, that might interfere with the results of the study; - Chronic infection - Known or suspected immune deficiency; - History of any neurologic disorder, including epilepsy; - Previous administration of serum products (including immunoglobulins) within 6 months before vaccination and blood sampling; - Known and/or suspected allergy to any of the vaccine components (by medical history); - Occurrence of a serious adverse events (SAEs) after primary DTwP-IPV vaccination, DTaP-IPV vaccination or any other vaccination (by medical history); - Vaccination with any other pertussis vaccine other than those described in the inclusion criteria (i.e. only according to NIP) - Vaccination with any other DT-IPV vaccine in the last 5 years, a DT-IPV vaccination according to NIP in cohort B is not an exclusion criterion; - Children between 8 and 10 years of age eligible for cohort A in the Netherlands who have already received the diphtheria and tetanus toxoid vaccine (DT)-IPV booster vaccination according to Dutch NIP around 9 years of age; - Mixed wP and aP priming within a participant, cohort B; - Pregnancy. Detailed considerations for this exclusion criteria in section 4.6. Temporary exclusion criteria - If a participant has a severe acute (infectious) illness or fever (>38°C) within 14 days prior to T0, participation will be postponed or cancelled. In case the participant has fever within 2 days before sampling at T4 or T5, the appointment will be postponed for 4 days, if possible. - Antibiotic use within 14 days of enrolment. - Any vaccination within a month before enrolment. | ||
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| 年龄 | 最小年龄：7 Years ，最大年龄：70 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Finland|Netherlands|United Kingdom | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | University of Oxford | ||
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| 验证日期 | August 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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