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| Name | Class |
|---|---|
| National Institute for Public Health and the Environment (RIVM) | OTHER_GOV |
| University of Turku | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children aged between 7-10 years of age | Active Comparator | 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. |
|
| Children aged between 11-15 years of age | Active Comparator | 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. |
|
| Adults aged between 20-34 years of age | Active Comparator | 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. |
|
| Adults aged between 60-70 years of age | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boostrix®-IPV combination vaccine | Biological | A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of pertussis toxin-specific IgG antibody levels to 28 days after vaccination | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of pertussis toxin (PT) specific IgG antibody one year after vaccination with Boostrix-IPV | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Temporary exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dr Marlies van Houten | Spaarne Hospital, Hoofddorp | Principal Investigator |
| Prof. dr. Jussi Mertsola | Turku University Hospital | Principal Investigator |
| Dr Dominic Kelly | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Turku | Turku | FI-20014 | Finland | |||
| Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM) |
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| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| 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 | 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 | 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 | 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 | 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. | 1 year although samples will be stored up to 10 years |
| Bilthoven |
| 3721 MA |
| Netherlands |
| Centre for Clinical Vaccinology & Tropical Medicine (CCVTM) | Oxford | Oxfordshire | OX3 7LE | United Kingdom |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |