Status:
COMPLETED
PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
Pfizer
Conditions:
IgG Deficiency
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 wi...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01847781
Start Date
May 1 2013
End Date
December 1 2013
Last Update
June 16 2014
Active Locations (1)
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1
Immunedeficiency Unit, Karolinska University Hospital, Huddinge
Stockholm, Sweden, 14186