A Study Exploring Whooping Cough Protection in Children and Adults

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

April 23, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

April 18, 2018

Estimated Primary Completion Date

August 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline of pertussis toxin-specific IgG antibody levels to 28 days after vaccination[ Time Frame: 28 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Amount of pertussis toxin (PT) specific IgG antibody one year after vaccination with Boostrix-IPV[ Time Frame: 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[ Time Frame: 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[ Time Frame: 28 days and 1 year ]
Change from baseline of functional pertussis-specific antibody levels to 28 days and 1 year after vaccination with Boostrix-IPV[ Time Frame: 28 days and 1 year ]
Change from baseline of B cell responses against Bordetella pertussis vaccine proteins after vaccination with Boostrix-IPV[ Time Frame: 7 days, 28 days and 1 year ]
Antigen-specific memory B cell responses against B-pertussis vaccine proteins
Change from baseline of pertussis antigen-specific T helper responses to 14 days, 28 days and 1 year after vaccination with Boostrix-IPV[ Time Frame: 14 days, 28 days and 1 year ]
To describe the effect on an aP booster on the specific T cell immune response in different age groups that have been initially vaccinated with either a whole cell or acellular vaccine
Identify markers in biological samples collected in the Biobank (library of samples) that show changes in immunity to pertussis[ Time Frame: 1 year although samples will be stored up to 10 years ]
Use of novel exploratory immunoassays on stored samples to identify biomarkers or lasting memory or waning immunity to pertussis.

Descriptive Information

Brief Title ^ICMJE

A Study Exploring Whooping Cough Protection in Children and Adults

Official Title ^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

Brief Summary

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.

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Biological: Boostrix®-IPV combination vaccine
A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.

Study Arms

Active Comparator: Children aged between 7-10 years of age
Healthy children from 7 up to 10 years of age, determined by date of birth (dd/mm/yyyy), at the time of the first visit. Male + female, approximately equally distributed, n = 36 in each country. They will receive Boostrix®-IPV combination vaccine.
Active Comparator: Children aged between 11-15 years of age
Healthy children from 11 up to 15 years of age, determined by date of birth (dd/mm/yyyy), at the time of the first visit. Male + female, approximately equally distributed, n = 36 in each country aiming for comparable numbers of participants with aP vs wP vaccination background. They will receive Boostrix®-IPV combination vaccine.
Active Comparator: Adults aged between 20-34 years of age
Healthy young adults from 20 up to 34 years of age, determined by date of birth (dd/mm/yyyy), at the time of the first visit. Male + female, approximately equally distributed, n = 25 in each country. They will receive Boostrix®-IPV combination vaccine.
Active Comparator: Adults aged between 60-70 years of age
Older adults from 60 up to 70 years of age determined by date of birth (dd/mm/yyyy), at the time of the first visit. Male + female, approximately equally distributed, n = 25 in each country. They will receive Boostrix®-IPV combination vaccine.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

122

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 31, 2019

Estimated Primary Completion Date

August 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

7 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Finland|Netherlands|United Kingdom

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of Oxford

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Dr Marlies van Houten Spaarne Hospital, Hoofddorp
Principal Investigator: Prof. dr. Jussi Mertsola Turku University Hospital
Principal Investigator: Dr Dominic Kelly University of Oxford

PRS Account

Verification Date

August 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名