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B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01846923
Recruitment Status : Unknown
Verified May 2013 by Vana Spoulou, Aghia Sophia Children's Hospital of Athens.
Recruitment status was:  Active, not recruiting
First Posted : May 6, 2013
Last Update Posted : May 6, 2013
Sponsor:
Information provided by (Responsible Party):
Vana Spoulou, Aghia Sophia Children's Hospital of Athens

Study Description
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Brief Summary:
The purpose of this study is to determine whether one dose of the 13-valent pneumococcal conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine influence the cellular immune response to PCV13 in this group.

Condition or disease Intervention/treatment Phase
Asplenia β-thalassemia Major Biological: PCV13 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of the B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals With Beta-thalassemia Major
Study Start Date : October 2010
Actual Primary Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PCV13 Biological: PCV13


Outcome Measures
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Primary Outcome Measures :
  1. immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot) [ Time Frame: One month post-PCV13 ]
  2. immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot) [ Time Frame: one month post PCV13 ]

Secondary Outcome Measures :
  1. Maintenance of B memory cells three years after PCV13 vaccination [ Time Frame: three years after study vaccination ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asplenia
  • β-thalassemia major
  • older than 18 years

Exclusion Criteria:

  • no previously recorded allergy to PCV
  • no intravenous immunoglobulin (IVIG) given within the previous 6 months
  • no other vaccine given within the previous 6 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846923


Locations
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Greece
'Aghia Sophia' Children's Hospital
Athens, Attiki, Greece, 11527
Sponsors and Collaborators
Aghia Sophia Children's Hospital of Athens
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vana Spoulou, Assistant Professor of Paediatrics, Aghia Sophia Children's Hospital of Athens
ClinicalTrials.gov Identifier: NCT01846923    
Other Study ID Numbers: 51657MoH
First Posted: May 6, 2013    Key Record Dates
Last Update Posted: May 6, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn