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

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.

Study Overview

• Status: Unknown
• Conditions: Immunogenicity, Vaccine; Immunologic Memory
• Intervention / Treatment: Biological: 13-valent pneumococcal conjugate vaccine (PCV13)

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Irene Tzovara, MD; Phone Number: 0030 2107467620; Email: itzovara@med.uoa.gr

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 11527
      • Recruiting
      • 'Aghia Sophia' Children's Hospital
      • Contact: Vana Spoulou; Phone Number: 00302107467620
      • Sub-Investigator: Irene Tzovara, MD
      • Principal Investigator: Ioanna Papadatou, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 15, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: isppd2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No