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

NCT03405805 | Unknown DMC

• 1 other identifier: isppd2018
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunogenicity, Vaccine; Immunologic Memory

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Transcriptional profile of Peripheral Blood Mononuclear Cells (PBMC) in response to PCV13 (measured by RNA-Sequencing)

  7 days post last vaccine dose

Study Arms (3)

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

13-valent pneumococcal conjugate vaccine (PCV13) BIOLOGICAL

Vaccination with PCV13

Also known as: Prevenar13

2+1; 3+0; 3+1

Eligibility Criteria

• Age: 2 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• months of age

You may not qualify if:

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

Sponsors & Collaborators

• Aghia Sophia Children's Hospital of Athens: lead

Study Sites (1)

'Aghia Sophia' Children's Hospital

Athens, Attica, 11527, Greece

RECRUITING

MeSH Terms

Interventions

13-valent pneumococcal vaccine

Study Officials

• Vana Spoulou, MD, PhD

  "Aghia Sophia" Children's Hospital

  STUDY CHAIR

Central Study Contacts

Irene Tzovara, MD

CONTACT

0030 2107467620; itzovara@med.uoa.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Paediatrics

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 23, 2018
• Study Start: December 12, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

GR (1)