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

Immunogenicity, Vaccine Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03405805
• Other study ID #: isppd2018
• Status: Recruiting
• Phase: N/A
• First received: January 15, 2018
• Last updated: January 15, 2018
• Start date: December 12, 2016
• Est. completion date: December 2019

Study information

• Verified date: January 2018
• Source: Aghia Sophia Children's Hospital of Athens
• Contact: Irene Tzovara, MD
• Phone: 0030 2107467620
• Email: itzovara[@]med.uoa.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 15 Months

Eligibility

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

Related Conditions & MeSH terms

• Immunogenicity, Vaccine
• Immunologic Memory

Intervention

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

Locations

Country	Name	City	State
Greece	'Aghia Sophia' Children's Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
Aghia Sophia Children's Hospital of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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