Clinical Trial: PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Karolinska University Hospital

Current Primary Outcome: Change in opsonophagocytic antibodies [ 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in cellular immunity [ 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.
  • Change in antimicrobial peptides [ 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.


Original Secondary Outcome: Same as current

Information By: Karolinska University Hospital

Dates:
Date Received: May 1, 2013
Date Started: May 2013
Date Completion:
Last Updated: June 13, 2014
Last Verified: June 2014