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

NCT ID: NCT01846923

Last Updated: 2013-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Brief Summary

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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

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Conditions

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Asplenia β-thalassemia Major

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PCV13

Group Type EXPERIMENTAL

PCV13

Intervention Type BIOLOGICAL

Interventions

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PCV13

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aghia Sophia Children's Hospital of Athens

OTHER

Sponsor Role lead

Responsible Party

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Vana Spoulou

Assistant Professor of Paediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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'Aghia Sophia' Children's Hospital

Athens, Attica, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 30683996 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24879786 (View on PubMed)

Other Identifiers

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51657MoH

Identifier Type: -

Identifier Source: org_study_id

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