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.
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
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
122
A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.
University of Turku
Turku, Finland
Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM)
Bilthoven, Netherlands
Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)
Oxford, Oxfordshire, United Kingdom
Change from baseline of pertussis toxin-specific IgG antibody levels to 28 days after vaccination
Time frame: 28 days
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
Antigen-specific memory B cell responses against B-pertussis vaccine proteins
Time frame: 7 days, 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
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
Time frame: 14 days, 28 days and 1 year
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Identify markers in biological samples collected in the Biobank (library of samples) that show changes in immunity to pertussis
Use of novel exploratory immunoassays on stored samples to identify biomarkers or lasting memory or waning immunity to pertussis.
Time frame: 1 year although samples will be stored up to 10 years