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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3+1 | 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. |
| |
| 3+0 | 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. |
| |
| 2+1 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine (PCV13) | Biological | Vaccination with PCV13 |
|
| Measure | Description | Time Frame |
|---|---|---|
| immunoglobulin G (IgG) antibody serum titers (measured by ELISA) | measurement of IgG antibody titers in serum pre- and post- last dose of PCV13 | 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 | 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 | 28 days post last vaccine dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days post last vaccine dose |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy infants 2-15 months of age living in Athens, Greece
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Tzovara, MD | Contact | 0030 2107467620 | itzovara@med.uoa.gr |
| Name | Affiliation | Role |
|---|---|---|
| Vana Spoulou, MD, PhD | "Aghia Sophia" Children's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 'Aghia Sophia' Children's Hospital | Recruiting | Athens | Attica | 11527 | Greece |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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