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

Karolinska University Hospital20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

IgG Deficiency

Interventions

Prevenar13BIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Immunedeficiency Unit, Karolinska University Hospital, Huddinge

Stockholm, Sweden

Outcomes

Primary Outcomes

Change in opsonophagocytic antibodies

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

Secondary Outcomes

Change in cellular immunity

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

Change in antimicrobial peptides

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.

Time frame: 4 weeks post-vaccination, change from baseline

Data from ClinicalTrials.gov

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