NCT03697798

A Study Exploring Whooping Cough Protection in Children and Adults

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 7 Years – 70 Years
• Healthy volunteers: Accepted

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

Conditions

• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Boostrix®-IPV combination vaccine	A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.

Timeline

• Start date: 2018-04-18
• Primary completion: 2020-01-14
• Completion: 2020-01-14
• First posted: 2018-10-05
• Last updated: 2021-01-08

Locations

3 sites across 3 countries: Finland, Netherlands, United Kingdom