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

Primary Purpose

Asplenia, β-thalassemia Major

Status
Unknown status
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
PCV13
Sponsored by
Aghia Sophia Children's Hospital of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asplenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 'Aghia Sophia' Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PCV13

Arm Description

Outcomes

Primary Outcome Measures

immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot)
immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot)

Secondary Outcome Measures

Maintenance of B memory cells three years after PCV13 vaccination

Full Information

First Posted
April 29, 2013
Last Updated
May 1, 2013
Sponsor
Aghia Sophia Children's Hospital of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT01846923
Brief Title
B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals
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 Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aghia Sophia Children's Hospital of Athens

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asplenia, β-thalassemia Major

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCV13
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
PCV13
Primary Outcome Measure Information:
Title
immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot)
Time Frame
One month post-PCV13
Title
immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot)
Time Frame
one month post PCV13
Secondary Outcome Measure Information:
Title
Maintenance of B memory cells three years after PCV13 vaccination
Time Frame
three years after study vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
'Aghia Sophia' Children's Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
30683996
Citation
Papadatou I, Lagousi T, Kattamis A, Spoulou V. Antibody persistence 5 years after a 13-valent pneumococcal conjugate vaccine in asplenic patients with beta-thalassemia: assessing the need for booster. Ann Hematol. 2019 Mar;98(3):775-779. doi: 10.1007/s00277-019-03615-z. Epub 2019 Jan 25.
Results Reference
derived
PubMed Identifier
24879786
Citation
Papadatou I, Piperi C, Alexandraki K, Kattamis A, Theodoridou M, Spoulou V. Antigen-specific B-cell response to 13-valent pneumococcal conjugate vaccine in asplenic individuals with beta-thalassemia previously immunized with 23-valent pneumococcal polysaccharide vaccine. Clin Infect Dis. 2014 Sep 15;59(6):862-5. doi: 10.1093/cid/ciu409. Epub 2014 May 30.
Results Reference
derived

Learn more about this trial

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

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