immune system of preterm born infants, response to vaccination
Conditions
Interventions
None listed
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
No minimum to 64 Years
Inclusion criteria
Inclusion criteria: • Preterm infant born at gestational age less than 32 weeks (whose mothers did or did not receive a T dap vaccination during pregnancy) OR healthy full-term infant whose mother received a Tdap vaccination during pregnancy • Mothers of included preterm infants •Parents/ guardians must have sufficient understanding of the Dutch language
Exclusion criteria
Exclusion criteria: • Parents/guardians not able or willing to provide informed consent • Infant with congenital anomaly which are more likely to cause adverse effects after immunization (for example hemodynamically significant congenital heart defect) • Infant with a (possible) HIV infection, immunodeficiency or use of immunomodulating drugs • Maternal use of immunosuppressive drugs during pregnancy • Parental intention not to vaccinate according to the National Immunization Program
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure blood IgG antibody concentrations against the antigen components of the hexavalent DTaP5-HB-IPV-Hib vaccine for the six preventable diseases (Diphtheria, Tetanus, Pertussis, Polio, Hepatitis-B, Haemophilus influenza type B) in preterm-born infants 3- 6 weeks after primary series of routine vaccinations in order to assess the proportion of children with IgG concentrations above international-defined thresholds for protection. This proportion will be compared with proportions in healthy term infants as known from literature. . | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the number and repertoire of blood antigen-specific memory B cells in term-born infants following routine vaccinations after primary series (age 6 months) and booster vaccination (age 12 or 13 months) 2. To assess number and repertoire of blood antigen-specific memory B cells in preterm-born infants following routine vaccinations after primary series (age 6 months) and booster vaccination (age 12 or 13 months) compared to term born infants 3. To assess blood IgG antibody concentrations against vaccine antigens in preterm-born infants following booster of routine vaccination with DTaP5-HB-IPV-Hib as a marker of immune maturation in premature children. 4. To assess blood IgG antibody 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 DTaP5-HB-IPV-Hib. 5. To assess blood IgG antibody concentrations against vaccine antigens in preterm-born infants following routine vaccinations with 10- or 15- valent pneumococcal conjugate vaccine after primary series and booster vaccination as a marker of immune maturation in premature children. 6. To assess blood 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. 7. To assess blood 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. 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 r | — |
Countries
Netherlands
Contacts
Public ContactM.J. Esser
Maastricht Universitair Medisch Centrum +
Outcome results
None listed