Response to pertussis (whooping cough) vaccination in infants Infections and Infestations
Conditions
Interventions
The study will recruit a total of 114 infants and randomise 1:1 to receive either wP or aP at 2 and 4 months of age (primary immunisations). The randomisation lists will be generated by the study stat
blood sample and nasal fluid sampling
immunisation either of DTaP-IPV-Hib-HepB vaccine (Infanrix-hexa) or DTwP-Hib-HepB/IPV vaccines (ComVac5 + Imvax Polio) together with routine vaccines, which are pneumococcal conjugate (PCV13) and rota
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Infants due to receive their primary immunisations, aged up to 10 weeks at first vaccinations 2. Born at =37 weeks of gestational age 3. Written informed consent given by parent(s) or legal guardian(s) aged =18 years 4. Parent(s) or legal guardian(s) willing and able to comply with the requirements of the protocol for the duration of the study 5. Mother received DTaP vaccine during pregnancy with participating infant
Exclusion criteria
Exclusion criteria: 1. Parent/guardian has any condition which in the opinion of the investigator may interfere with the ability to fulfil study requirements. This may include plans to move house and language comprehension. 2. Mother was receiving immunosuppressive treatment during pregnancy or is known to be HIV-positive 3. In care (with safeguarding in place) 4. Child of parents who are on the delegation log for this study 5. Prior or planned receipt of any other investigational vaccine/drug or if currently participating in other research study, at investigator discretion 6. Major congenital defects or serious chronic illness 7. Bleeding disorder 8. Confirmed or suspected immunodeficiency 9. Family history of congenital or hereditary immunodeficiency 10. Receipt of more than 1 week of immune-suppressants or immune modifying drugs (e.g. oral prednisolone >0.5 ml/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed. 11. Administration of immunoglobulin and/or any blood products since birth or planned administration during the study period 12. History of allergy to any component of the vaccines 13. History of pertussis disease/whooping cough confirmed by laboratory analysis (serology, culture or other available methods) Temporary exclusion criteria Visits where vaccines are administered should be delayed: 14. In the presence of an acute illness or the presence of fever =38ºC, until 72 h after resolution 15. For at least 6 h since last dose of ibuprofen/paracetamol 16. For 48 h after finishing an antibiotic treatment All the treatments should be documented in the CRF at the time of the visit (name, dose, duration of treatment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pertussis toxin (PT)-specific antibody geometric mean concentration (GMC) measured using a flow cytometry method with antigen-coated fluorescent beads (Bioplex/Luminex) at 13 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pertussis toxin (PT)-specific antibody geometric mean concentration (GMC) measured using using a flow cytometry method with antigen-coated fluorescent beads (Bioplex/Luminex) at 2, 5 and 12 months of age 2. Filamentous hemagglutinin (FHA)-specific antibody GMC measured using using a flow cytometry method with antigen-coated fluorescent beads (Bioplex/Luminex) at 2, 5, 12 and 13 months of age 3. Pertactin (PRN)-specific antibody GMC measured using using a flow cytometry method with antigen-coated fluorescent beads (Bioplex/Luminex) at 2, 5, 12 and 13 months of age 4. Bordetella pertussis fimbriae (FIM)-specific antibody GMC measured using using a flow cytometry method with antigen-coated fluorescent beads (Bioplex/Luminex) at 2, 5, 12 and 13 months of age 5. Pertussis antigen-specific memory B-cell geometric mean frequencies measured by ELISpot at 5, 12, and 13 months of age 6. Pertussis antigen-specific T-cell responses measured following antigen-specific restimulation at 5 months of age. Whole blood will be stimulated with antigens according to a protocol developed as part of the PERISCOPE consortium. The stimulated cells and supernatants will then be frozen pending subsequent transfer to collaborators in the PERISCOPE consortium for analysis by flow cytometry and cytokine detection in supernatants. 7. Hib-specific antibody responses measured using using a flow cytometry method with antigen-coated fluorescent beads (Bioplex/Luminex) at 2, 5, 12 and 13 months 8. Diphtheria-specific antibody responses measured using using a flow cytometry method with antigen-coated fluorescent beads (Bioplex/Luminex) at 2, 5, 12 and 13 months 9. Tetanus-specific antibody responses measured using using a flow cytometry method with antigen-coated fluorescent beads (Bioplex/Luminex) at 2, 5, 12 and 13 months 10. Pneumococcal-specific antibody responses measured using using a flow cytometry method with antigen-coated fluorescent beads (Bioplex/Luminex) at 2, 5, 12 and 13 months 11. | — |
Countries
England, United Kingdom
Outcome results
None listed