PertussisPhase 4BERTNCT03697798
A Study Exploring Whooping Cough Protection in Children and Adults
A Phase 4 study testing Boostrix®-IPV combination vaccine in people with Pertussis, run by University of Oxford at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 7 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- Boostrix®-IPV combination vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 18 Apr 2018to 14 Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 16Show fewer
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Netherlands1 site
Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM)
Bilthoven, 3721 MA
United Kingdom1 site
Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: 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
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.
Read the 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
- Being tested
- Boostrix®-IPV combination vaccine
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boostrix®-IPV combination vaccineBiological
A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: 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. Receives: Biological: 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. Receives: Biological: 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. Receives: Biological: Boostrix®-IPV combination vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of pertussis toxin-specific IgG antibody levels to 28 days after vaccination
Measured: 28 days
Secondary outcomes (7)
Amount of pertussis toxin (PT) specific IgG antibody one year after vaccination with Boostrix-IPV
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 1 year although samples will be stored up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start18 Apr 2018
- Primary completion14 Jan 2020
- Study completion14 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Public Health and the Environment (RIVM), University of Turku
- Responsible party
- Sponsor
- Investigators
- Dr Marlies van Houten, Principal investigator, Spaarne Hospital, HoofddorpProf. dr. Jussi Mertsola, Principal investigator, Turku University HospitalDr Dominic Kelly, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697798
- Sponsor's protocol ID
- OVG 2016/05
- Acronym
- BERT
- Status last verified
- Jan 2021
- First submitted
- 23 Apr 2018
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03697798
- Acronym / sponsor ID
- BERT / OVG 2016/05
- Conditions
- Pertussis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute for Public Health and the Environment (RIVM), University of Turku
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children aged between 7-10 years of age | Active comparator | Biological: Boostrix®-IPV combination vaccineHealthy 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 | Biological: Boostrix®-IPV combination vaccineHealthy 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 | Biological: Boostrix®-IPV combination vaccineHealthy 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 | Biological: Boostrix®-IPV combination vaccineOlder 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. |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boostrix®-IPV combination vaccineA licensed aP (acellular) booster vaccine developed by GlaxoSmithKline. | Biological | Adults aged between 20-34 years of age, Adults aged between 60-70 years of age, Children aged between 11-15 years of age, Children aged between 7-10 years of age |
Primary outcome
Change from baseline of pertussis toxin-specific IgG antibody levels to 28 days after vaccination
Time frame: 28 days
7 secondary outcomes
Amount of pertussis toxin (PT) specific IgG antibody one year after vaccination with Boostrix-IPV
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 28 days and 1 year
Change from baseline of B cell responses against Bordetella pertussis vaccine proteins after vaccination with Boostrix-IPV
Time frame: 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
Time frame: 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
Time frame: 1 year although samples will be stored up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
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Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Marlies van Houten principal investigator
Spaarne Hospital, Hoofddorp
Prof. dr. Jussi Mertsola principal investigator
Turku University Hospital
Dr Dominic Kelly principal investigator
University of Oxford
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Boostrix®-IPV combination vaccine in people with Pertussis, run by University of Oxford at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of pertussis toxin-specific IgG antibody levels to 28 days after vaccination (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.