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
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
-
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.
-
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.