Immunedeficiency Unit, Karolinska University Hospital, Huddinge
Stockholm, 14186, Sweden
NCT Number: NCT01847781
The aim is to study the immune response to conjugated pneumococcal vaccination (Prevenar13) in Immunoglobulin G-deficient patients and healthy controls. Our hypothesis is that the antibody response will be impaired in patients as compared with controls. In contrast, we postulate that the cellular immune response will be intact.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Stockholm, 14186, Sweden
Ten patients with Immunoglobulin G1 and/or Immunoglobulin G2 deficiency will be enrolled together with 10 age and sex- matched controls. Blood-samples will be drawn at base-line and after 1, 2 and 4 weeks post-vaccination. Serum will be analyzed for opsonophagocytic antibodies. Peripheral blood monocytic cells (PBMCs) will be isolated, frozen and later analyzed for all time-points simultaneously. PBMCs will be stimulated with vaccine-antigens for 3-5 days and cellular activation markers will be measured together with cytokines (Interferon-gamma, Interleukin (IL)-5, IL-13, IL-10, IL-17, IL-22). In addition, levels of antimicrobial peptides in nasal fluid will be measured at baseline and after 4 weeks post-vaccination.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 4 weeks post-vaccination, change from baseline
Titers of opsonophagocytic antibodies will be measured at baseline and 4 weeks post-vaccination. Titers from 4 weeks post-vaccination will be compared with baseline-levels.
Time frame: 4 weeks post-vaccination, change from baseline
PBMCs will be collected and stimulated with vaccine-antigens. Cellular activation markers and cytokine release will be measured and results from 4 weeks post-vaccination will be compared with baseline-levels.
Time frame: 4 weeks post-vaccination, change from baseline
Levels of AMPs in nasal fluid will be measured at 0 and 4 weeks post-vaccination. Results from 4 weeks will be compared with base-line levels.
Karolinska University Hospital
Other
Acronym: PNEUMOCELL
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