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

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ClinicalTrials.gov Identifier: NCT01847781
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : June 16, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Peter Bergman, 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.

Condition or disease Intervention/treatment Phase
IgG Deficiency Biological: Prevenar13 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency
Study Start Date : May 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013


Arm Intervention/treatment
Active Comparator: IgG-deficient patients
Prevenar13
Biological: Prevenar13
Active Comparator: Healthy controls
Prevenar13
Biological: Prevenar13



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847781


Locations
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Sweden
Immunedeficiency Unit, Karolinska University Hospital, Huddinge
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Pfizer
Investigators
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Principal Investigator: Peter W Bergman, MD, PhD Karolinska University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peter Bergman, Associate Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01847781     History of Changes
Other Study ID Numbers: 2012-004486-41
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014
Keywords provided by Peter Bergman, Karolinska University Hospital:
Opsonophagocytic antibodies
Cellular immunity
Vaccine immunity
Antimicrobial peptides
Additional relevant MeSH terms:
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IgG Deficiency
Dysgammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
Heptavalent Pneumococcal Conjugate Vaccine
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs