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

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NCT01847781

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Study Location
Immunedeficiency Unit, Karolinska University Hospital, Huddinge
Stockholm, , 14186, Sweden
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
IgG Deficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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IgG DeficiencyPNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency
NCT01847781
  1. Stockholm,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE IgG Deficiency
Intervention  ICMJE Biological: Prevenar13
Study Arms  ICMJE
  • Active Comparator: IgG-deficient patients
    Prevenar13
    Intervention: Biological: Prevenar13
  • Active Comparator: Healthy controls
    Prevenar13
    Intervention: Biological: Prevenar13
Publications * Zangenah S, Björkhem-Bergman L, Norlin AC, Hansen S, Lindqvist L, Henriques-Normark B, Bergman P. The Pneumocell-study: Vaccination of IgG1- and IgG2-deficient patients with Prevnar13. Vaccine. 2017 May 9;35(20):2654-2660. doi: 10.1016/j.vaccine.2017.03.097. Epub 2017 Apr 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2013)		20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01847781
Other Study ID Numbers  ICMJE 2012-004486-41
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Bergman, Karolinska University Hospital
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Peter W Bergman, MD, PhDKarolinska University Hospital
PRS Account Karolinska University Hospital
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP