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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03697798
Other study ID # OVG 2016/05
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 18, 2018
Est. completion date January 14, 2020

Study information

Verified date January 2021
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date January 14, 2020
Est. primary completion date January 14, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 70 Years
Eligibility Inclusion Criteria: - Normal general health - Within the right age group for the cohort - Received all regular vaccines for their age group according to the Dutch NIP, UK NIP or Finnish NIP; a copy of the vaccination booklet will be included in the participant's documents. If booklet is not available for cohorts A, B and C, vaccination status will be checked although, for cohort C and D this booklet might not be available due to their age; - Provision of written informed consent - Willing to adhere to the protocol and be available during the study period. Exclusion Criteria: - Present evidence of serious disease(s) within the last 3 months before inclusion requiring immunosuppressive or immune modulating medical treatment, such as systemic corticosteroids, that might interfere with the results of the study; - Chronic infection - Known or suspected immune deficiency; - History of any neurologic disorder, including epilepsy; - Previous administration of serum products (including immunoglobulins) within 6 months before vaccination and blood sampling; - Known and/or suspected allergy to any of the vaccine components (by medical history); - Occurrence of a serious adverse events (SAEs) after primary DTwP-IPV vaccination, DTaP-IPV vaccination or any other vaccination (by medical history); - Vaccination with any other pertussis vaccine other than those described in the inclusion criteria (i.e. only according to NIP) - Vaccination with any other DT-IPV vaccine in the last 5 years, a DT-IPV vaccination according to NIP in cohort B is not an exclusion criterion; - Children between 8 and 10 years of age eligible for cohort A in the Netherlands who have already received the diphtheria and tetanus toxoid vaccine (DT)-IPV booster vaccination according to Dutch NIP around 9 years of age; - Mixed wP and aP priming within a participant, cohort B; - Pregnancy. Detailed considerations for this exclusion criteria in section 4.6. Temporary exclusion criteria - If a participant has a severe acute (infectious) illness or fever (>38°C) within 14 days prior to T0, participation will be postponed or cancelled. In case the participant has fever within 2 days before sampling at T4 or T5, the appointment will be postponed for 4 days, if possible. - Antibiotic use within 14 days of enrolment. - Any vaccination within a month before enrolment.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Boostrix®-IPV combination vaccine
A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.

Locations

Country Name City State
Finland University of Turku Turku
Netherlands Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM) Bilthoven
United Kingdom Centre for Clinical Vaccinology & Tropical Medicine (CCVTM) Oxford Oxfordshire

Sponsors (3)

Lead Sponsor Collaborator
University of Oxford National Institute for Public Health and the Environment (RIVM), University of Turku

Countries where clinical trial is conducted

Finland,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline of pertussis toxin-specific IgG antibody levels to 28 days after vaccination 28 days
Secondary Amount of pertussis toxin (PT) specific IgG antibody one year after vaccination with Boostrix-IPV 1 year
Secondary Change from baseline in pertussis toxin (PT) specific IgG-subclasses and avidity levels to 28 days and 1 year after vaccination with Boostrix-IPV 28 days and 1 year
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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