NCT03697798已完成4 期
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
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 6
- 主要终点
- Change from baseline of pertussis toxin-specific IgG antibody levels to 28 days after vaccination
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
Change from baseline of pertussis toxin-specific IgG antibody levels to 28 days after vaccination
时间窗: 28 days
次要结局
- Change from baseline of B cell responses against Bordetella pertussis vaccine proteins after vaccination with Boostrix-IPV(7 days, 28 days and 1 year)
- Change from baseline of antigen-specific IgG antibody levels against other pertussis vaccine antigens (such as FHA) and non-pertussis vaccine antigens (such as diptheria and tetanus toxoid) to 28 days and 1 year after vaccination with Boostrix-IPV(28 days and 1 year)
- Change from baseline in pertussis toxin (PT) specific IgG-subclasses and avidity levels to 28 days and 1 year after vaccination with Boostrix-IPV(28 days and 1 year)
- Amount of pertussis toxin (PT) specific IgG antibody one year after vaccination with Boostrix-IPV(1 year)
- Identify markers in biological samples collected in the Biobank (library of samples) that show changes in immunity to pertussis(1 year although samples will be stored up to 10 years)
- Change from baseline of functional pertussis-specific antibody levels to 28 days and 1 year after vaccination with Boostrix-IPV(28 days and 1 year)
- Change from baseline of pertussis antigen-specific T helper responses to 14 days, 28 days and 1 year after vaccination with Boostrix-IPV(14 days, 28 days and 1 year)
研究者
研究点 (6)
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