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

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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

Tracking Information
First Submitted Date  ICMJE April 29, 2013
First Posted Date  ICMJE May 6, 2013
Last Update Posted Date May 6, 2013
Study Start Date  ICMJE October 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2013)
  • immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot) [ Time Frame: One month post-PCV13 ]
  • immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot) [ Time Frame: one month post PCV13 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2013)		 Maintenance of B memory cells three years after PCV13 vaccination [ Time Frame: three years after study vaccination ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals
Official Title  ICMJE Study of the B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals With Beta-thalassemia Major
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Asplenia
  • β-thalassemia Major
Intervention  ICMJE Biological: PCV13
Study Arms  ICMJE Experimental: PCV13
Intervention: Biological: PCV13
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: May 1, 2013)		 37
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01846923
Other Study ID Numbers  ICMJE 51657MoH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vana Spoulou, Aghia Sophia Children's Hospital of Athens
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aghia Sophia Children's Hospital of Athens
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aghia Sophia Children's Hospital of Athens
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP