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.
Study Type
OBSERVATIONAL
Enrollment
145
Amphia Hospital
Breda, Netherlands
RECRUITINGreinier de Graaff Group
Delft, Netherlands
RECRUITINGAlbert Schweitzer Hospital
Dordrecht, Netherlands
antibody immune response to routine vaccinations in very preterm infants
IgG antibody concentrations against six vaccine antigens in preterm-born infants following primary series of routine vaccinations with Vaxelis in order to assess the proportion of children with IgG concentrations above international-defined thresholds for protection.
Time frame: 6 months
IgG antibody concentrations following booster of routine vaccination with Vaxelis
IgG antibody concentrations against vaccine antigens in preterm-born infants following booster of routine vaccination with Vaxelis.
Time frame: 12 months
geometrical mean concentrations following primary series and booster of routine vaccination with Vaxelis.
geometrical mean concentrations in preterm infants compared to reference values in healthy term infants as known from literature following primary series and booster of routine vaccination with Vaxelis.
Time frame: 6 and 12 months
IgG antibody concentrations following routine vaccinations with 10-valent pneumococcal conjugate vaccine after primary series and booster vaccination.
IgG antibody concentrations against vaccine antigens in preterm-born infants following routine vaccinations with 10-valent pneumococcal conjugate vaccine after primary series and booster vaccination.
Time frame: 6 and 12 months
IgG antibody concentrations against pertussis antigens at 2 months of age in preterm-born infants after maternal Tdap vaccination and in infants whose mother did not receive maternal Tdap vaccination.
IgG antibody concentrations against pertussis antigens at 2 months of age (before start of infant immunizations) in preterm-born infants after maternal Tdap vaccination and in infants whose mother did not receive maternal Tdap vaccination.
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Erasmus MC
Rotterdam, Netherlands
RECRUITINGFranciscus Gasthuis
Rotterdam, Netherlands
RECRUITINGMaasstad Hospital
Rotterdam, Netherlands
RECRUITINGMaxima Medical Center
Veldhoven, Netherlands
RECRUITINGTime frame: 2 months
number of antigen-specific memory B cells in cells/microliter following routine vaccinations after primary series and booster vaccination
number of antigen-specific memory B cells in cells/microliter in preterm-born infants following routine vaccinations after primary series and booster vaccination
Time frame: 6 and 12 months
IgG antibody concentrations in relation to maternal antibody concentrations against vaccine antigens
IgG antibody concentrations against vaccine antigens in preterm-born infants before start of immunizations and following routine vaccinations after primary series and booster vaccination, in relation to maternal antibody concentrations against vaccine antigens
Time frame: birth, 2,6 and 12 months
comparison of response to vaccination between preterm infants and healthy term infants
Proportions of infants with IgG concentrations above the internationally defined threshold for protection and geometrical mean concentrations will be compared between preterm infants after maternal Tdap vaccination, preterm infants whose mothers did not receive Tdap vaccination and reference values in healthy term infants as known from literature.
Time frame: 6 and 12 months
Comparison of number of antigen-specific memory B cells in cells/microliter with and without preceding maternal Tdap vaccination
Number of antigen-specific memory B cells in cells/microliter will be compared between preterm infants after maternal Tdap vaccination, preterm infants whose mothers did not receive Tdap vaccination and healthy term infants after maternal Tdap vaccination, who will be recruited for this study.
Time frame: 6 and 12 months