Condition category
Infections and Infestations
Date applied
23/04/2008
Date assigned
05/03/2009
Last edited
13/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Saskia van der Lee

ORCID ID

Contact details

National Institute of Public Health and Environmental Protection (RIVM)
Antoni van Leeuwenhoeklaan 9
Bilthoven
3720 BA
Netherlands
+31 (0)30 274 3407
Saskia.van.der.lee@rivm.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LIS-142

Study information

Scientific title

The 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

Acronym

Study hypothesis

Whooping 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

The Dutch Central Committee on Research involving Human Subjects (CCMO), 23/12/2008, ref: NL 23149.000.08

Study design

Single-centre interventional single-arm non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Whooping cough

Intervention

The 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 type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

The 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 measures

If 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 trial start date

01/02/2009

Overall trial end date

11/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

86

Participant exclusion criteria

Any 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

Recruitment start date

01/02/2009

Recruitment end date

09/04/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

Antoni van Leeuwenhoeklaan 9
Bilthoven
3720 BA
Netherlands

Sponsor type

Research organisation

Website

http://www.rivm.nl

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/22064265
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22860033

Publication citations

  1. Results

    Schure RM, de Rond L, Oztürk K, Hendrikx L, Sanders E, Berbers G, Buisman AM, Pertussis circulation has increased T-cell immunity during childhood more than a second acellular booster vaccination in Dutch children 9 years of age., PLoS ONE, 2012, 7, 7, e41928, doi: 10.1371/journal.pone.0041928.

  2. Results

    Hendrikx LH, Felderhof MK, Ozturk K, de Rond LG, van Houten MA, Sanders EA, Buisman AM, Enhanced memory B-cell immune responses after a second acellular pertussis booster vaccination in children 9 years of age, Vaccine, 2011, 30, 1, 51-58, doi: 10.1016/j.vaccine.2011.10.048.

Additional files

Editorial Notes