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

Aghia Sophia Children's Hospital of Athens

Status: Unknown

Conditions: Immunologic Memory; Immunogenicity, Vaccine

Treatments: Biological: 13-valent pneumococcal conjugate vaccine (PCV13)

Study type: Observational

Funder types: Other

Identifiers

NCT03405805

isppd2018

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 15 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

3+1

Description:

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.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine (PCV13)

3+0

Description:

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.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine (PCV13)

2+1

Description:

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.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine (PCV13)