PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency
PNEUMOCELL
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJune 16, 2014
June 1, 2014
6 months
May 1, 2013
June 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 weeks post-vaccination, change from baseline
Secondary Outcomes (2)
Change in cellular immunity
4 weeks post-vaccination, change from baseline
Change in antimicrobial peptides
4 weeks post-vaccination, change from baseline
Study Arms (2)
IgG-deficient patients
ACTIVE COMPARATORPrevenar13
Healthy controls
ACTIVE COMPARATORPrevenar13
Interventions
Eligibility Criteria
You may qualify if:
- Immunoglobulin gamma-deficiency: Immunoglobulin gamma 1-deficiency \< 2,8 g/L and/or Immunoglobulin gamma 2-deficiency \< 1,15 g/L
- Age 18-65
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska University Hospitallead
- Pfizercollaborator
Study Sites (1)
Immunedeficiency Unit, Karolinska University Hospital, Huddinge
Stockholm, 14186, Sweden
Related Publications (1)
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.
PMID: 28410816DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter W Bergman, MD, PhD
Karolinska University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 1, 2013
First Posted
May 7, 2013
Study Start
May 1, 2013
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
June 16, 2014
Record last verified: 2014-06