whooping cough
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: Child
Exclusion criteria
Exclusion criteria: Households: * With a pregnant contact (>34 weeks of gestation) * With a contact younger than 6 months old or unvaccinated child. * With a contact with significant disorders, including immunodeficiency, cancer, oral steroid therapy or any other medical conditions * With risk contacts for which antibiotic prophylaxis is recommended for the whole household. * In which it is not possible to organize visit T1 within 5 days. Incapacitated Household contacts will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to identify differences in immunological biomarkers at inclusion (T1) between confirmed infection (asymptomatic) and confirmed pertussis (symptomatic) in cases. We will measure immunological biomarkers in blood and in mucosal samples of household contacts at inclusion (T1) as well as changes in immunological biomarkers from T1 to T2 (=2 months after T1). As the primary objective, we will investigate differences in PT antibody responses at T1 and T2 between confirmed pertussis and confirmed infection (asymptomatic) cases (see highlighted rows in Table . Primary endpoint. PT-IgG and PT-IgA geometric mean concentrations at T1 and T2 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are to compare other immunological biomarkers measured in blood and mucosal samples at inclusion (T1), as well as changes in immunological biomarkers between T1, TS and T2 in relation to the case definitions described above. These include: comparison of mucosal and serum antibody responses, including functional antibody responses, and T and B cell responses in confirmed pertussis (symptomatic) and confirmed infection (asymptomatic) cases. Secondary endpoints: 1. Serum IgG and IgA GMC titers against other pertussis antigens (including Prn, FHA and Fim) at T1, T2 and TS 2. Mucosal IgG and IgA GMC titers against pertussis antigens (including PT, Prn, FHA and Fim) at T1, T2 and TS 3. Frequency of pertussis-antigen specific memory B cells and their ratio*s at T1 and T2 4. Pertussis antigen-specific T cell responses and their ratio*s at T1 and T2. 5. Pertussis-specific T and B cell responses at TS. 6. Assessment of functional pertussis-specific antibody levels in serum and mucosal samples at all time points | — |
Countries
Netherlands
Outcome results
None listed