This study is going to focus on the immunisations against pertussis disease in previous healthy children, but the disease itself is not going to be study. MedDRA version: 20.0 Level: PT Classification code 10034738 Term: Pertussis System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: LLT Classification code 10047976 Term: Whooping cough due to bordetella pertussis (B. pertussis) System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Imovax ® Polio
Product Name: Imovax ® Polio
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Purified inactivated poliomyelitis vaccine
Concentration unit: U unit(s)
Concen
Sponsors
Clinical Trials and Research Governance (CTRG), University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Infants due to receive their primary immunisations, aged up to 10 weeks at first vaccinations. • Infants born at = 37 weeks of gestational age • Written informed consent given by 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. • Maternal immunisation: received dtap vaccine during the current pregnancy Are the trial subjects under 18? yes Number of subjects for this age range: 114 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Mothers: • 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) • Receipt of immunosuppressive treatment during pregnancy or known HIV positive Infants: • 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 vaccines • History of pertussis disease/whooping cough confirmed by laboratory analysis (serology, culture or other available methods)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to determine whether the differences in the immune responses of infants when given either the aP or wP vaccine could explain the differences seen in long-term vaccine effectiveness. The study also aims to explore whether maternal aP vaccination influences infant immune response to aP and wP and whether this has a bearing on long-term vaccine effectiveness. The primary objective of the study is to investigate Pertussis Toxin (PT) specific antibody responses as a marker of memory following an aP booster given at 12 months of age to infants primed with aP versus wP vaccines.;Secondary Objective: 1. To compare the baseline and post vaccination immune response and antibody levels in infants primed with aP versus wP vaccines 2. To compare pertussis specific memory B-cell (cells of the immune system) numbers at 5, 12, and 13 months of age in infants primed with aP versus wP vaccines 3. To compare pertussis antigen specific Th1, Th2 and Th17 (cells of the immune system) responses at 5 months of age, in infants primed with aP versus wP vaccines 4. To compare Pertussis Toxin-specific antibody responses in infants primed with aP versus wP vaccine 5. To compare other pertussis specific antibody responses in infants primed with aP versus wP 6. To compare serological responses to the non-pertussis vaccines (Hib, diphtheria, tetanus, pneumococcus, polio) in infants primed with aP versus wP vaccines 7. Assessment of pertussis specific functional antibodies prior to and after immunisation with aP versus wP vaccines 8. To determine the induction and persistence of mucosal anti;Primary end point(s): Pertussis Toxin-specific antibody Geometric Mean Concentration (GMC) at 13 months in aP versus wP groups;Timepoint(s) of evaluation of this end point: The time point will be the blood sample taken at 13 months of age, after the booster vaccination at 12 months of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Percentage reduction in PT, FHA, PRN and FIM antibody GMC at 5, 12, and 13 months of age for each 2-fold higher baseline antibody concentration in the aP versus wP groups. 2. Pertussis antigen-specific memory B-cell geometric mean frequencies at 5, 12, and 13 months of age measured by ELISpot in the aP versus wP groups. 3.Pertussis antigen-specific Th1, Th2 and Th17 responses and their ratios determined by flow-cytometry and cytokine analysis following antigen-specific culture (the ‘Whole bloodT-cell assay’) 4. PT-specific antibody GMC at 5, and 12months of age in the aP versus wP groups 5.FHA, PRN and FIM specific antibody GMCs prior to immunisation and at 5, 12 and 13 months of age 6.Hib, diphtheria, tetanus, and pneumococcal-specific antibody responses at baseline, 5, 12, and 13 months in the aP versus wP groups 7.Assays of pertussis specific functional antibodies may include: adherence inhibition; bacterial agglutination; bactericidal activity; bacterial opsonization and phagocytosis undertaken on serum or plasma samples taken at 2 (prior to immunisation), 5, 12,and 13 months of age;Timepoint(s) of evaluation of this end point: The endpoints will be measured at time points including: 2 months, +1 day, +3 days; 4 months, +7 days, +14 days; 5 months; 12 months and 13 months as described above. | — |
Countries
United Kingdom
Contacts
Public ContactDominic Kelly
University of Oxford - Oxford Vaccine Group
Outcome results
None listed