Immunological Memory Against Pneumococcus Induced by 3 Infant PCV 13 Vaccination Schedules

The Establishment of Serotype-specific Immunological Memory Against Pneumococcus by a 3+1 Versus a 2+1 or 3+0 Infant PCV13 Vaccination Schedule

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03405805

Enrollment

Registered

2018-01-23

Start date

2016-12-12

Completion date

2019-12-31

Last updated

2018-01-23

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

Conditions

Immunogenicity, Vaccine, Immunologic Memory

Brief summary

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.

Interventions

BIOLOGICAL13-valent pneumococcal conjugate vaccine (PCV13)

Vaccination with PCV13

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Months to 15 Months

Healthy volunteers

Yes

Inclusion criteria

* 2-15 months of age

Exclusion criteria

* previously recorded allergy to PCV * intravenous immunoglobulin (IVIG) given within the previous 6 months * primary or secondary immunodeficiency * any chronic medical condition

Design outcomes

Primary

Measure	Time frame	Description
immunoglobulin G (IgG) antibody serum titers (measured by ELISA)	28 days post last vaccine dose	measurement of IgG antibody titers in serum pre- and post- last dose of PCV13
switched immunoglobulin G (swIgG) B memory cell response (measured by flow cytometry)	28 days post last vaccine dose	phenotype characterisation of swIgG memory B cells pre- and post- last dose of PCV13
immunoglobulin M (IgM) B memory cell response (measured by flow cytometry)	28 days post last vaccine dose	phenotype characterisation of IgM memory B cells pre- and post- last dose of PCV13

Secondary

Measure	Time frame	Description
Transcriptional profile of Peripheral Blood Mononuclear Cells (PBMC) in response to PCV13 (measured by RNA-Sequencing)	7 days post last vaccine dose	transcriptome analysis of PBMCs pre- and post last dose of PCV13 on a cohort of patients

Countries

Greece

Contacts

Primary ContactIrene Tzovara, MD

itzovara@med.uoa.gr0030 2107467620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026