Pertussis Whoping Cough
Conditions
Interventions
Participants will receive one injection of reduced diphtheria toxoid, tetanus
toxoid and reduced acellular pertussis vaccine (dTap)-IPV, (Boostrix® IPV,
GlaxoSmithKline (GSK)) combination vaccine in
Pertussis
Whooping cough
Sponsors
RIVM
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: * normal general health; * within the right age group for the cohort; * received all regular vaccines for their age group according to the Dutch National immunisation programme (NIP), UK NIP or Finnish NIP; a copy of the vaccination booklet will be included in the participant*s documents. If booklet is not available for cohorts A, B and C, vaccination status will be checked with regulatory agencies / General practitioner. For cohort D this booklet might not be available due to their age; * provision of written informed consent (see section 11.2 for details); * willing to adhere to the protocol and be available during the study period.
Exclusion criteria
Exclusion criteria: * present evidence of serious disease(s) within the last 3 months before inclusion requiring immunosuppressive or immune modulating medical treatment, such as systemic corticosteroids, that might interfere with the results of the study; * chronic infection; * known or suspected immune deficiency; * history of any neurologic disorder, including epilepsy; * previous administration of serum products (including immunoglobulins) within 6 months before vaccination and blood sampling; * known or suspected allergy to any of the vaccine components (by medical history); * occurrence of serious adverse events (SAEs) after primary DTwP-IPV (Diphtheria, Tetanus, whole-cell Pertussis, Polio) vaccination, DTaP-IPV (Diphtheria, Tetanus, acellular Pertussis, Polio) vaccination or any other vaccination (by medical history); * vaccination with any other pertussis vaccine than those described in the inclusion criteria (i.e. only according to NIP); * vaccination with any other Diphtheria, Tetanus and polio (DT-IPV) vaccine in the last 5 years, DT-IPV vaccination according to NIP in cohort B is no exclusion; * children between 8 and 10 years of age eligible for cohort A in the Netherlands who have already received the DT-IPV booster vaccination according to the Dutch NIP around 9 years of age; * mixed whole-cell pertussis (wP) and acellular pertussis (aP) priming within a participant, cohort B; * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PT specific IgG antibodies at day 28 (T4). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/outcome of the study (if applicable): *PT specific IgG antibodies and their avidity at T0, T4 and T5. Specific IgG-levels to other pertussis vaccine antigens, as well as to non-pertussis antigens will be determined at T0, T4 and T5, using a PERISCOPE serological multiplex immunoassay. * Functional pertussis-specific antibody levels will be determined in serum samples at T0, T4 and T5, using PERISCOPE core assays as described in section 8.3.4. Differences in levels of functional antibodies will be measured before and after vaccination. Functional antibody assays include bacterial adherence inhibition (BAI), PT neutralisation (PTNA), serum bactericidal activity (SBA), and bacterial opsonophagocytosis assay (OPA). Other serological parameters such as avidity, subclass distribution (IgA, IgM) are optional in serum samples. * Antigen-specific memory B cell responses at time points T0, T2, T4 and T5 will be measured to determine the effects of aP booster vaccination in children, young adults and elderly, using PERISCOPE B cell core assay. * Characterisation of the effect of an aP booster on the specific T cell immune response, both early after the boost and later on, in different age groups, vaccinated initially either with a whole cell or an acellular vaccine. * Collection and biobanking of biological samples to be used for testing in novel exploratory immunoassays and for possible bridging to other pertussis vaccine studies. Exploratory study parameters/outcome of the study (if applicable): * Differences in T cell programming will be measured on fresh blood samples or frozen PBMC samples in an exploratory PERISCOPE T cell assay. This assay includes but is not limited to multi-colour flow cytometry and/or mass cytometry (CyTOF), combined with supernatant cytokine analysis. * To assess differences in epigenetic imprinting of immune cells by primary vaccination on dTap-IPV booster vaccination, material for epigenetic ma | — |
Countries
The Netherlands
Outcome results
None listed