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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03405805
Recruitment Status : Unknown
Verified January 2018 by Vana Spoulou, Aghia Sophia Children's Hospital of Athens.
Recruitment status was:  Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Vana Spoulou, Aghia Sophia Children's Hospital of Athens

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
Immunogenicity, Vaccine Immunologic Memory Biological: 13-valent pneumococcal conjugate vaccine (PCV13)

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Study Type : Observational
Estimated 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 : December 12, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


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 Name: 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 Name: 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 Name: Prevenar13




Primary Outcome Measures :
  1. immunoglobulin G (IgG) antibody serum titers (measured by ELISA) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 7 days post last vaccine dose ]
    transcriptome analysis of PBMCs pre- and post last dose of PCV13 on a cohort of patients



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy infants 2-15 months of age living in Athens, Greece
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405805


Contacts
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Contact: Irene Tzovara, MD 0030 2107467620 itzovara@med.uoa.gr

Locations
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Greece
'Aghia Sophia' Children's Hospital Recruiting
Athens, Attiki, Greece, 11527
Contact: Vana Spoulou    00302107467620      
Sub-Investigator: Irene Tzovara, MD         
Principal Investigator: Ioanna Papadatou, MD, PhD         
Sponsors and Collaborators
Aghia Sophia Children's Hospital of Athens
Investigators
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Study Chair: Vana Spoulou, MD, PhD "Aghia Sophia" Children's Hospital
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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: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs