An observational study in Immunogenicity, Vaccine and Immunologic Memory, sponsored by Aghia Sophia Children's Hospital of Athens. Status unknown at 1 site in Greece. Open to participants aged 2 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Aghia Sophia Children's Hospital of Athens · Observational
The purpose of this study is to evaluate the establishment of immunological memory between the 3 different infant vaccination schedules with the 13-valent pneumococcal conjugate vaccine (PCV13) currently in use. We aim to determine the optimal schedule for the establishment of antigen-specific memory B-cell pool, which may serve as a correlate for longevity of immunological memory against vaccine serotypes. Moreover, we will study the transcriptome profiles expressed by peripheral lymphocytes during each immune response in an attempt to reveal immunological mechanisms beyond the antibody and circulating B cells level.
Healthy infants 2-15 months of age living in Athens, Greece
Exclusion Criteria:
Healthy infants will receive 4 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4,6 and 12 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose.
Biological: 13-valent pneumococcal conjugate vaccine (PCV13)
Healthy infants will receive 3 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4 and 6 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose.
Biological: 13-valent pneumococcal conjugate vaccine (PCV13)
Healthy infants will receive 3 doses of the 13-valent pneumococcal conjugate vaccine (PCV13) at 2,4 and 12 months of age and blood and serum collection pre- dose, 7 days post- (only blood) and 28 days post- last dose.
Biological: 13-valent pneumococcal conjugate vaccine (PCV13)
Vaccination with PCV13
Also known as: Prevenar13
immunoglobulin G (IgG) antibody serum titers (measured by ELISA)
measurement of IgG antibody titers in serum pre- and post- last dose of PCV13
Time frame: 28 days post last vaccine dose
switched immunoglobulin G (swIgG) B memory cell response (measured by flow cytometry)
phenotype characterisation of swIgG memory B cells pre- and post- last dose of PCV13
Time frame: 28 days post last vaccine dose
immunoglobulin M (IgM) B memory cell response (measured by flow cytometry)
phenotype characterisation of IgM memory B cells pre- and post- last dose of PCV13
Time frame: 28 days post last vaccine dose
Transcriptional profile of Peripheral Blood Mononuclear Cells (PBMC) in response to PCV13 (measured by RNA-Sequencing)
transcriptome analysis of PBMCs pre- and post last dose of PCV13 on a cohort of patients
Time frame: 7 days post last vaccine dose
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Aghia Sophia Children's Hospital of Athens