Booster study: long term cellular memory immunity against Bordetella pertussis

ISRCTN ISRCTN64117538
DOI https://doi.org/10.1186/ISRCTN64117538
Secondary identifying numbers LIS-142
Submission date
23/04/2008
Registration date
05/03/2009
Last edited
13/05/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Saskia van der Lee
Scientific

National Institute of Public Health and Environmental Protection (RIVM)
Antoni van Leeuwenhoeklaan 9
Bilthoven
3720 BA
Netherlands

Phone +31 (0)30 274 3407
Email Saskia.van.der.lee@rivm.nl

Study information

Study designSingle-centre interventional single-arm non-randomised study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe longitudinal kinetics of long term cellular memory immunity against Bordetella pertussis in Dutch 8 to 9 year old children after acellular pertussis vaccine (ACV) booster vaccination
Study objectivesWhooping cough is a respiratory disease, caused by Bordetella pertussis. Whooping cough is a serious disease in the young, vulnerable infant. Older children and adults are the main source of infection.

Since the incidence of whooping cough (pertussis) is increasing in the Netherlands, the effect of vaccination against Bordetella pertussis needs to be addressed. Because of the increasing incidence of whooping cough at the age of 4, an acellular pertussis vaccine (ACV) booster vaccination at 4 years of age was introduced in the Netherlands in 2001. However, nowadays the peak incidence of whooping cough in children has shifted to 8 to 9 year old children. In addition, we also see a rise in notifications in adolescents and adults. Therefore, in some countries, e.g. Germany and France, an extra acellular booster vaccination has been given to the 9 to 14 year old children. Also in Belgium they will introduce an extra booster vaccination in 14 to 16 year old children. Because of the shift in the prevalence peak, the effect of the booster vaccination on the long term immunity against Bordetella pertussis needs to be addressed in this specific age group.

This study aims to investigate the longitudinal kinetics of the effect of the ACV booster vaccination on the memory of B- and T-cell immunity in children who are primary vaccinated with whole cell vaccine (WCV) and boostered with ACV. Furthermore, the relationship between the cellular immunity and the antibody responses after ACV booster will be addressed in order to gain insight if further booster vaccinations are required.

On 13/05/2015 the following changes were made to the trial record:
1. The overall trial end date was changed from 01/06/2010 to 11/11/2014.
2. The target number of participants was changed from 70 to 86.
Ethics approval(s)The Dutch Central Committee on Research involving Human Subjects (CCMO), 23/12/2008, ref: NL 23149.000.08
Health condition(s) or problem(s) studiedWhooping cough
InterventionThe combination vaccine diphtheria, tetanus, pertussis acellular vaccination, poliomyelitis (DTPacv-IPV) (Boostrix polio™, 0.5 ml) produced by GlaxoSmithKline (GSK) containing a three-component ACV (pertussis toxin [Ptx], filamentous haemagglutinin [FHA] and pertactin [Prn]), tetanustoxoid, difterietoxoid and inactivated polio virus, will be given intramuscularly to 8 to 9 year old children who received the DTPwcv-IPV-(Hib) at 2, 3, 4 and 11 months old and DTP and a three component ACV (monovalent ACV by GSK) as a booster vaccination at 4 years old. The extra pertussis vaccination is combined with the DT-IPV and measles, mumps and rubella (MMR) vaccination which they receive in the regular immunisation program. One pre- and two post-vaccination (28 days and 1 year) blood samples will be taken.

Added 13/05/2015:
In addition, from a subset of children, a blood sample will be collected 5.5 years after vaccination.
Intervention typeBiological/Vaccine
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureThe main study parameters will be pertussis specific memory B- and T-cell responses as well as antibody levels and affinity against the various proteins of pertussis and the other components of the DTPacv-IPV-Hib vaccine.
Secondary outcome measuresIf there are enough lymphocytes, the immune response (memory B- and T-cells and antibody responses) to other vaccine preventable diseases, like measles, mumps, diphtheria, tetanus and polio will also be measured.
Overall study start date01/02/2009
Completion date11/11/2014

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit8 Years
Upper age limit9 Years
SexBoth
Target number of participants86
Key inclusion criteria1. Healthy 8 to 9 year old children, either sex
2. Received four vaccinations at 2, 3, 4 and 11 months with diphtheria, tetanus, pertussis whole cell vaccine, poliomyelitis - haemophilus influenzae type b (DTPwcv IPV-Hib)
3. Received a booster vaccination at 4 years old with a three component ACV
Key exclusion criteriaAny of the following criteria will exclude a volunteer from participation, at start of the study:
1. Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like corticosteroids that might interfere with the results of the study within three months
2. Any known primary or secondary immunodeficiency
Date of first enrolment01/02/2009
Date of final enrolment09/04/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

National Institute of Public Health and Environmental Protection (RIVM)
Bilthoven
3720 BA
Netherlands

Sponsor information

National Institute of Public Health and Environmental Protection (RIVM) (Netherlands)
Research organisation

Antoni van Leeuwenhoeklaan 9
Bilthoven
3720 BA
Netherlands

Website http://www.rivm.nl
ROR logo "ROR" https://ror.org/01cesdt21

Funders

Funder type

Research organisation

National Institute of Public Health and Environmental Protection (RIVM) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 09/12/2011 Yes No
Results article results 01/12/2012 Yes No