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

Primary Purpose

IgG Deficiency

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Prevenar13
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for IgG Deficiency focused on measuring Opsonophagocytic antibodies, Cellular immunity, Vaccine immunity, Antimicrobial peptides

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Immunedeficiency Unit, Karolinska University Hospital, Huddinge

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

IgG-deficient patients

Healthy controls

Arm Description

Prevenar13

Prevenar13

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 1, 2013
Last Updated
June 13, 2014
Sponsor
Karolinska University Hospital
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01847781
Brief Title
PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency
Acronym
PNEUMOCELL
Official Title
PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgG Deficiency
Keywords
Opsonophagocytic antibodies, Cellular immunity, Vaccine immunity, Antimicrobial peptides

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IgG-deficient patients
Arm Type
Active Comparator
Arm Description
Prevenar13
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
Prevenar13
Intervention Type
Biological
Intervention Name(s)
Prevenar13
Primary Outcome Measure Information:
Title
Change in opsonophagocytic antibodies
Description
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 Outcome Measure Information:
Title
Change in cellular immunity
Description
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
Title
Change in antimicrobial peptides
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter W Bergman, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Immunedeficiency Unit, Karolinska University Hospital, Huddinge
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28410816
Citation
Zangenah S, Bjorkhem-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.
Results Reference
derived

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

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