Welcome
Support Centre
22 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Booster study: long term cellular memory immunity against Bordetella pertussis
ISRCTN ISRCTN64117538
DOI 10.1186/ISRCTN64117538
ClinicalTrials.gov identifier
EudraCT number
Public title Booster study: long term cellular memory immunity against Bordetella pertussis
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 N/A
Serial number at source LIS/IMM138
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.
Lay summary Not provided at time of registration
Ethics approval The Dutch Central Committee on Research involving Human Subjects (CCMO) gave approval on the 23rd December 2008 (ref: NL 23149.000.08)
Study design Single-centre, interventional, single arm, non-randomised study
Countries of recruitment Netherlands
Disease/condition/study domain Whooping cough
Participants - 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
Participants - 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
Anticipated start date 01/02/2009
Anticipated end date 01/06/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 70
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding National Institute of Public Health and Environmental Protection (RIVM) (Netherlands)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22860033
Contact name Mrs  Lotte  Hendrikx
  Address National Institute of Public Health and Environmental Protection (RIVM)
Antoni van Leeuwenhoeklaan 9
  City/town Bilthoven
  Zip/Postcode 3720 BA
  Country Netherlands
  Tel +31 (0)30 274 3944
  Fax +31 (0)30 274 4418
  Email Lotte.Hendrikx@rivm.nl
Sponsor National Institute of Public Health and Environmental Protection (RIVM) (Netherlands)
  Address Antoni van Leeuwenhoeklaan 9
  City/town Bilthoven
  Zip/Postcode 3720 BA
  Country Netherlands
  Sponsor website: http://www.rivm.nl
Date applied 23/04/2008
Last edited 08/10/2012
Date ISRCTN assigned 05/03/2009
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.