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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01846923
Enrollment
37
Registered
2013-05-06
Start date
2010-10-31
Completion date
Unknown
Last updated
2013-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asplenia, β-thalassemia Major

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.

Interventions

BIOLOGICALPCV13

Sponsors

Aghia Sophia Children's Hospital of Athens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Maintenance of B memory cells three years after PCV13 vaccinationthree years after study vaccination

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026