Skip to content

Long-term cellular memory immunity against Bordetella pertussis and other components of the DTP-IPV-Hib vaccine in Dutch children: comparison of a whole cell vaccine (WCV) with an acellular vaccine (ACV)

Long-term cellular memory immunity against Bordetella pertussis and other components of the DTP-IPV-Hib vaccine in Dutch children: comparison of a whole cell vaccine (WCV) with an acellular vaccine (ACV) - observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN65428640
Enrollment
420
Registered
2008-11-07
Start date
2006-09-01
Completion date
Unknown
Last updated
2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Whooping cough/ Bordetella pertussis infection Infections and Infestations Whooping cough

Interventions

This is an observational, cohort study. Recruitment will be carried out in two stages. Populations of children at different ages who already had received four vaccinations at 2, 3, 4

Sponsors

National Institute for Public Health and the Environment (RIVM) (The Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Both male and female children, aged 3 to 9 years old 2. Infants in good general health (eligible) who have been vaccinated according to the Dutch national vaccination programme 3. Provision of written informed consent by both parents and legal representatives

Exclusion criteria

Exclusion criteria: 1. Present evidence of serious disease(s) demanding immunosuppressive medical treatment, such as corticosteroids, that might interfere with the results of the study within 3 months 2. Any known primary or secondary immunodeficiency 3. Vaccination with any other vaccine than those used in the National Immunisation Programme (Rijks Vaccinatie Programma [RVP]) within a month before the blood sampling

Design outcomes

Primary

MeasureTime frame
B cell and T cell immune responses: Peripheral blood mononuclear cells (PBMC's) will be isolated from the blood samples. PBMC's will be divided in purified B cell populations and T cell populations. B cells will be cultured and memory B cells will be polyclonal stimulated. After 5 days stimulation, B cell memory responses will be measured against the various proteins of B pertussis (filamentous hemagglutinin adhesin [FHA], pertactin [PRN], pertussis toxin [PT], fimbriae [Fim], lipopolysaccharide [LPS]) by ELIspot assays and enzyme-linked immunosorbent assay (ELISA)/Luminex® of the culture supernatants. T cells will be stimulated with the various proteins of B. pertussis and at 24 hours and 5 days of culture, cells and supernatants will be harvested. Memory T cell responses will be measured by IFN-y and/or IL2 ELIspot assays. TH1/TH2 ratios will be measured by analysing cytokines in the culture supernatants by Luminex® bead protein assay or ELISA. All data collection will be completed by the end of 2010.

Secondary

MeasureTime frame
Blood samples will be separated in PBMC's and plasma samples. The plasma samples will be used to measure antibody responses against the various proteins of B. pertussis as well as against the other proteins of the DKT-IPV-HIB vaccine. Plasma parameter assays: 1. Pertussis (PT, PRN, FHA, FIM2 and FIM3): IgG antibody titer is measured in an ELISA/Luminex® with two-fold serial dilution series in duplicate using FDA reference serum as standard (EU/ml) 2. Diphtheria, tetanus: IgG antibody titer is measured in a ToBI-ELSA/Luminex® with twofold serial dilution series in duplicate using the national reference serum (IU/ml) as standard which is calibrated on the World Health Organization (WHO) standard 3. Haemophilus influenzae type b (Hib): IgG antibody titer is measured in an ELISA/Luminex® with two-fold serial dilution series in duplicate using CBER-FDA reference serum as standard (µg/ml) 4. Polio: total Ig is measured in a neutralisation assay on Vero cells with two-fold serial dilution series in duplicate using the WHO reference serum as standard 5. To monitor the effect of WCV or ACV on TH2 mediated disease manifestations, total IgE levels and some components of the DTP-IPV-Hib vaccine (PT and tetanus) will be measured in the plasma 6. Mucosal IgA antibodies will be measured in the plasmas All data collection will be completed by the end of 2010.

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026