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

ß-thalassemia Major Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01846923
• Other study ID #: 51657MoH
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 29, 2013
• Last updated: May 1, 2013
• Start date: October 2010

Study information

• Verified date: May 2013
• Source: Aghia Sophia Children's Hospital of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeGreece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Asplenia

• ß-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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asplenia
• Beta-Thalassemia
• ß-thalassemia Major
• Thalassemia

Intervention

Biological:
• PCV13

Locations

Country	Name	City	State
Greece	'Aghia Sophia' Children's Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
Aghia Sophia Children's Hospital of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot)		One month post-PCV13	No
Primary	immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot)		one month post PCV13	No
Secondary	Maintenance of B memory cells three years after PCV13 vaccination		three years after study vaccination	No