A Phase 4 interventional study of Boostrix®-IPV combination vaccine in Pertussis, sponsored by University of Oxford. Completed at 3 sites in 3 countries. Open to participants aged 7 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by University of Oxford · Phase 4, Interventional, and Prevention
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:
238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.
This study's enrollment of 122 is below the median of 375 across 180 interventional studies indexed under Whooping Cough.
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Exclusion Criteria:
Temporary exclusion criteria
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.
Biological: Boostrix®-IPV combination vaccine
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.
Biological: Boostrix®-IPV combination vaccine
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.
Biological: Boostrix®-IPV combination vaccine
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.
Biological: Boostrix®-IPV combination vaccine
A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.
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
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
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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University of Oxford