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

Phase 4

• Conditions: Asplenia; β-thalassemia Major
• Interventions: Biological: PCV13

• Registration Number: NCT01846923
• Lead Sponsor: Aghia Sophia Children's Hospital of Athens

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 available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2012-02
• Study First Submitted: 2013-04-29
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-01
• Last Update Submitted: 2013-05-01
• Study First Posted: 2013-05-06
• Last Update Posted: 2013-05-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PCV13	PCV13	-

Primary Outcome Measures

Name	Time	Method
immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot)	One month post-PCV13
immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot)	one month post PCV13

Secondary Outcome Measures

Name	Time	Method
Maintenance of B memory cells three years after PCV13 vaccination	three years after study vaccination

Trial Locations

Locations (1)

'Aghia Sophia' Children's Hospital; 🇬🇷 Athens, Attiki, Greece