immunogeniciteit Pertussis whooping cough
Conditions
Interventions
All infants will receive the oral rotavirus vaccine at 2 months of age.
At 3 months of age all infants will receive the Infanrix-hexa vaccine and the
pneumococcal vaccine and the second rotavirus vac
Sponsors
RIVM
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: * Infants born with * 37 weeks of gestational age * Written informed consent given by both parent(s) or legal guardian(s) who is aged *18 years * Parent(s) or legal guardian(s) willing and able to comply with the requirements of the protocol for the duration of the study. * Infants due to receive their primary immunisations, aged up to 6-8 weeks at first vaccinations. * Maternal immunisation: - Exclusively for Arm 1: Received Tdap vaccine during the current pregnancy - Exclusively for Arm 2: Not received Tdap during the current pregnancy
Exclusion criteria
Exclusion criteria: * Child in care (with safeguarding in place) * Children of parents who are on the delegation log for this study * Prior or planned receipt of any other investigational vaccine/drug or if current participation in other research study, at investigator discretion * Major congenital defects or serious chronic illness * Bleeding disorder * Confirmed or suspected immunodeficiency * A family history of congenital or hereditary immunodeficiency * Receipt of more than 1 week of immune-suppressants or immune modifying drugs (e.g. oral prednisolone >0.5ml/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed. * Administration of immunoglobulin and/or any blood products since birth or planned administration during the study period * History of allergy to any component of the vaccine * History of pertussis disease/whooping cough confirmed by laboratory analysis (serology, culture or other available methods). Visits where vaccines are administered should be delayed * in the presence of an acute illness or the presence of fever *38ºC, until 72 hours after resolution * for at least 6 hours since last dose of ibuprofen/ paracetamol * 48 hours after finishing an antibiotic treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pertussis toxin-specific antibody Geometric Mean Concentration (GMC) at 6 months in infants from Arm 1 versus Arm 2 groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome: 1. Immune response in PT, FHA, Prn and FIM antibody GMC at 6 months of age in Arm 1 vs Arm 2 groups. 2. Frequencies of Pertussis antigen-specific memory B-cells at 6 months of age measured by ELISpot in the Arm 1 vs Arm 2 infants. 3. Pertussis antigen-specific T cell frequencies and their phenotype determined by cytokine analysis of stimulated whole blood/ PBMCs and/or supernatants. 4. Hib, diphtheria, tetanus, and pneumococcal-specific antibody responses at baseline and 6 months in Arm 1 vs Arm 2 infants. 5. Assays of pertussis specific functional antibodies may include: PT neutralization; adherence inhibition; bacterial agglutination; bactericidal activity; bacterial opsonization and phagocytosis undertaken on serum or plasma samples taken at 3 (prior to immunisation) and 6 months of age (1 month after the second dose). Exploratory outcome: 1. Measurement of gene expression analysis and innate immune function before vaccination(3 months) and at day 1 after the first dose of aP in Arm 1 vs Arm 2 and correlation with vaccine immunogenicity. 2. Pertussis antigen specific plasma cell responses after dose 2 (day 7) in the Arm 1 group using B-cell ELISpot assays. 3. PT, FHA or Prn specific antibody responses at days 7 and 14 after the second dose of aP in Arm 1. 4. IgA and IgG antibodies against pertussis antigens and other possible soluble factors in the eluate from nasosorption will be analysed by Luminex multiplex immunoassay. | — |
Countries
Netherlands
Outcome results
None listed