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In this study the response to vaccination and development of the immune system in very preterm infants upon the current vaccination schedule will be compared to healthy term infants.
Preterm infants are at increased risk of developing infections early in life due to a less mature immune system compared to full-term infants. Moreover, protection by the placental transfer of maternal antibodies in general and specifically against vaccine antigens has shown to be significantly lower in very preterm infants (gestational age (GA)\< 32 weeks) compared to term infants. In this study we aim to investigate the immune system development of very preterm infants. Adequate immune response to vaccination is considered both clinically important as well as a functional test of the immune system. However, data on the antibody and Ag-specific memory B cell response to vaccination in preterm infants are limited. Primary objective is to study the antibody immune response to routine vaccinations in very preterm infants (GA\<32 weeks). Secondary aim is to study the immune system more extensively using flow cytometry, ELISA and single cell transcriptomics to measure development of Ag-specific memory B cells raised in response to vaccination, and by using proteomics, epigenetics, and microbiome studies.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
Yes
Amphia Hospital
Breda, Netherlands
reinier de Graaff Group
Delft, Netherlands
Albert Schweitzer Hospital
Dordrecht, Netherlands
Erasmus MC
Rotterdam, Netherlands
Franciscus Gasthuis
Rotterdam, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
Maxima Medical Center
Veldhoven, Netherlands
Start Date
December 8, 2022
Primary Completion Date
July 1, 2025
Completion Date
July 1, 2026
Last Updated
March 20, 2024
145
ESTIMATED participants
Lead Sponsor
Maastricht University Medical Center
Collaborators
NCT06315556
NCT07061366
Data Source & Attribution
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