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

May 1, 2013 updated by: Vana Spoulou, Aghia Sophia Children's Hospital of Athens

Study of the B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals With Beta-thalassemia Major

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 11527
        • 'Aghia Sophia' Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PCV13
Biological: PCV13

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot)
Time Frame: One month post-PCV13
One month post-PCV13
immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot)
Time Frame: one month post PCV13
one month post PCV13

Secondary Outcome Measures

Outcome Measure
Time Frame
Maintenance of B memory cells three years after PCV13 vaccination
Time Frame: three years after study vaccination
three years after study vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aghia Sophia Children's Hospital of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

May 1, 2013

First Posted (Estimate)

May 6, 2013

Study Record Updates

Last Update Posted (Estimate)

May 6, 2013

Last Update Submitted That Met QC Criteria

May 1, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51657MoH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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