Brief Title
A Study Exploring Whooping Cough Protection in Children and Adults
Official Title
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Change from baseline of pertussis toxin-specific IgG antibody levels to 28 days after vaccination
Secondary Outcome
Amount of pertussis toxin (PT) specific IgG antibody one year after vaccination with Boostrix-IPV
Condition
Pertussis
Intervention
Boostrix®-IPV combination vaccine
Study Arms / Comparison Groups
Children aged between 7-10 years of age
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
122
Start Date
April 18, 2018
Completion Date
January 14, 2020
Primary Completion Date
January 14, 2020
Eligibility Criteria
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.
Gender
All
Ages
7 Years - 70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Dr Marlies van Houten, ,
Location Countries
Finland
Location Countries
Finland
Administrative Informations
NCT ID
NCT03697798
Organization ID
OVG 2016/05
Responsible Party
Sponsor
Study Sponsor
University of Oxford
Collaborators
National Institute for Public Health and the Environment (RIVM)
Study Sponsor
Dr Marlies van Houten, Principal Investigator, Spaarne Hospital, Hoofddorp
Verification Date
January 2021