A Study Exploring Whooping Cough Protection in Children and Adults

NCT ID: NCT03697798

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-18
• Study Completion Date: 2020-01-14

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Children aged between 7-10 years of age

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.

Group Type: ACTIVE_COMPARATOR

Boostrix®-IPV combination vaccine

Intervention Type: BIOLOGICAL

A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.

Children aged between 11-15 years of age

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.

Group Type: ACTIVE_COMPARATOR

Boostrix®-IPV combination vaccine

Intervention Type: BIOLOGICAL

A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.

Adults aged between 20-34 years of age

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.

Group Type: ACTIVE_COMPARATOR

Boostrix®-IPV combination vaccine

Intervention Type: BIOLOGICAL

A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.

Adults aged between 60-70 years of age

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.

Group Type: ACTIVE_COMPARATOR

Boostrix®-IPV combination vaccine

Intervention Type: BIOLOGICAL

A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.

Interventions

Boostrix®-IPV combination vaccine

A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• 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;

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);

• 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute for Public Health and the Environment (RIVM)

OTHER_GOV

Sponsor Role: collaborator

University of Turku

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Marlies van Houten

Role: PRINCIPAL_INVESTIGATOR

Spaarne Hospital, Hoofddorp

Prof. dr. Jussi Mertsola

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Dr Dominic Kelly

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

University of Turku

Turku, , Finland

Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM)

Bilthoven, , Netherlands

Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)

Oxford, Oxfordshire, United Kingdom

Countries

Finland; Netherlands; United Kingdom

Other Identifiers

OVG 2016/05

Identifier Type: -

Identifier Source: org_study_id