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
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.
Status | Active, not recruiting |
Enrollment | 37 |
Est. completion date | |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Greece | 'Aghia Sophia' Children's Hospital | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
Aghia Sophia Children's Hospital of Athens |
Greece,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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