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
Scientific
National Institute of Public Health and Environmental Protection (RIVM)
Antoni van Leeuwenhoeklaan 9
Bilthoven
3720 BA
Netherlands
| Phone | +31 (0)30 274 3407 |
|---|---|
| Saskia.van.der.lee@rivm.nl |
Study information
| Study design | Single-centre interventional single-arm non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/02/2009 |
| Completion date | 11/11/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 9 Years |
| Sex | Both |
| Target number of participants | 86 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2009 |
| Date of final enrolment | 09/04/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
National Institute of Public Health and Environmental Protection (RIVM)
Bilthoven
3720 BA
Netherlands
3720 BA
Netherlands
Sponsor information
National Institute of Public Health and Environmental Protection (RIVM) (Netherlands)
Research organisation
Research organisation
Antoni van Leeuwenhoeklaan 9
Bilthoven
3720 BA
Netherlands
| Website | http://www.rivm.nl |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
