Overview

This trial is active, not recruiting.

Conditions asplenia, β-thalassemia major
Treatment pcv13
Phase phase 4
Sponsor Aghia Sophia Children's Hospital of Athens
Start date October 2010
End date February 2012
Trial size 37 participants
Trial identifier NCT01846923, 51657MoH

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
pcv13

Primary Outcomes

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

Secondary Outcomes

Measure
Maintenance of B memory cells three years after PCV13 vaccination
time frame: three years after study vaccination

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Aghia Sophia Children's Hospital of Athens.