PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency

Phase 2

Completed

• Conditions: IgG Deficiency
• Interventions: Biological: Prevenar13

• Registration Number: NCT01847781
• Lead Sponsor: Karolinska University Hospital

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 Description

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-06
• Study First Posted: 2013-05-07
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-13
• Last Update Posted: 2014-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Immunoglobulin gamma-deficiency: Immunoglobulin gamma 1-deficiency < 2,8 g/L and/or Immunoglobulin gamma 2-deficiency < 1,15 g/L
• Age 18-65

Exclusion Criteria

• Immunoglobulin gamma-substitution for 6 months prior to study inclusion
• Prevenar7 or Prevenar13 given prior to study inclusion.
• Pneumovax given during a 2 year period prior to study inclusion
• Pregnancy or planning to become pregnant during the study period (4 weeks)
• Taking part in another clinical study involving drugs or vaccinations during the study period (4 weeks).
• Taking systemic steroids, Non steroidal anti inflammatory drugs (NSAID) or immunosuppressive drugs.
• Being allergic to any substance in the vaccine.
• Acute and ongoing disease with high fever.
• Thrombocytopenia (< 100x109/L).
• Coagulopathy
• Breastfeeding a baby
• The healthy controls should not have any disease with effects on the immune-system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IgG-deficient patients	Prevenar13	Prevenar13
Healthy controls	Prevenar13	Prevenar13

Primary Outcome Measures

Name	Time	Method
Change in opsonophagocytic antibodies	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.

Secondary Outcome Measures

Name	Time	Method
Change in cellular immunity	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	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.

Trial Locations

Locations (1)

Immunedeficiency Unit, Karolinska University Hospital, Huddinge; 🇸🇪 Stockholm, Sweden