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

Sponsor
Aghia Sophia Children's Hospital of Athens (Other)
Overall Status
Unknown status
CT.gov ID
NCT03405805
Collaborator
(none)
60
Enrollment
1
Location
35.6
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: 13-valent pneumococcal conjugate vaccine (PCV13)

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Establishment of Serotype-specific Immunological Memory Against Pneumococcus by a 3+1 Versus a 2+1 or 3+0 Infant PCV13 Vaccination Schedule
Actual Study Start Date :
Dec 12, 2016
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

Biological: 13-valent pneumococcal conjugate vaccine (PCV13)
Vaccination with PCV13
Other Names:
  • Prevenar13

    		•
    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.

    Biological: 13-valent pneumococcal conjugate vaccine (PCV13)
    Vaccination with PCV13
    Other Names:
  • Prevenar13

    		•
    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.

    Biological: 13-valent pneumococcal conjugate vaccine (PCV13)
    Vaccination with PCV13
    Other Names:
  • Prevenar13

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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 Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Months to 15 Months
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 'Aghia Sophia' Children's Hospital Athens Attiki Greece 11527

    Sponsors and Collaborators

    • Aghia Sophia Children's Hospital of Athens

    Investigators

    • Study Chair: Vana Spoulou, MD, PhD, "Aghia Sophia" Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vana Spoulou, Assistant Professor of Paediatrics, Aghia Sophia Children's Hospital of Athens
    ClinicalTrials.gov Identifier:
    NCT03405805
    Other Study ID Numbers:
    • isppd2018
    First Posted:
    Jan 23, 2018
    Last Update Posted:
    Jan 23, 2018
    Last Verified:
    Jan 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heptavalent Pneumococcal Conjugate Vaccine

    Study Results

    No Results Posted as of Jan 23, 2018