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

Aghia Sophia Children's Hospital of Athens

Status and phase: Unknown; Phase 4

Conditions: β-thalassemia Major; Asplenia

Treatments: Biological: PCV13

Study type: Interventional

Funder types: Other

Identifiers

NCT01846923

51657MoH

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

PCV13

Experimental group

Treatment:

Biological: PCV13