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Status unknownNCT03405805Updated Jan 23, 2018

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

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 sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
2 Months to 15 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Immunogenicity, Vaccine
  • Immunologic Memory
03

In context

Lead sponsor

Aghia Sophia Children's Hospital of Athens is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 15 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy infants 2-15 months of age living in Athens, Greece

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 2-15 months of age

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

  • 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)

  • 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)

Interventions

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • 'Aghia Sophia' Children's Hospital
    Athens, Attiki 11527, Greece
    Recruiting
    • Vana Spoulou · Contact00302107467620
    • Irene Tzovara, MD · Sub investigator
    • Ioanna Papadatou, MD, PhD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2016 (actual). Primary completion is estimated for Dec 2018, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2018
First posted
Jan 23, 2018
StartActual
Dec 12, 2016
Primary completionEst.
Dec 2018
CompletionEst.
Dec 2019
Last update
Jan 23, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03405805
Lead sponsor
Aghia Sophia Children's Hospital of Athens
Responsible party
Vana Spoulou (Assistant Professor of Paediatrics, Aghia Sophia Children's Hospital of Athens) — Principal investigator
First posted
Jan 23, 2018
Start date
Dec 12, 2016
Primary completion
Dec 2018 (estimated)
Completion
Dec 2019 (estimated)
Last update
Jan 23, 2018

Study contacts

Irene Tzovara, MD
Contact
itzovara@med.uoa.gr
0030 2107467620
Vana Spoulou, MD, PhD
study chair · "Aghia Sophia" Children's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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