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

June 13, 2014 updated by: Peter Bergman, Karolinska University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Immunedeficiency Unit, Karolinska University Hospital, Huddinge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IgG-deficient patients
Prevenar13
Biological: Prevenar13
Active Comparator: Healthy controls
Prevenar13
Biological: Prevenar13

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks post-vaccination, change from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks post-vaccination, change from baseline
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.
4 weeks post-vaccination, change from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Pfizer

Investigators

  • Principal Investigator: Peter W Bergman, MD, PhD, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (Estimate)

May 7, 2013

Study Record Updates

Last Update Posted (Estimate)

June 16, 2014

Last Update Submitted That Met QC Criteria

June 13, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-004486-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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