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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03697798
Study type Interventional
Source University of Oxford
Contact
Status Completed
Phase Phase 4
Start date April 18, 2018
Completion date January 14, 2020

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