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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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IgG Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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IgG-deficient patients

Prevenar13

Group Type ACTIVE_COMPARATOR

Prevenar13

Intervention Type BIOLOGICAL

Healthy controls

Prevenar13

Group Type ACTIVE_COMPARATOR

Prevenar13

Intervention Type BIOLOGICAL

Interventions

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Prevenar13

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes