Preterm Immune System Development and Response to Immunization
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-2
SponsorMaastricht University Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Preterm infant born at gestational age less than 32 weeks (whose mothers did or did not receive a T dap vaccination during pregnancy)
Parents/ guardians must have sufficient understanding of the Dutch language
healthy full-term infant whose mother received a Tdap vaccination during pregnancy
Parents/ guardians must have sufficient understanding of the Dutch language
Disqualifiers
Parents/guardians of the infant are 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 or immunodeficiency
Maternal use of immunosuppressive drugs during pregnancy
Trial population
For this study 120 preterm infants (GA\< 32 weeks) and their mothers will be enrolled to evaluate the antibody response to vaccination and the development of the immune system. In a subgroup of 25 preterm infants after maternal Tdap vaccination and 25 preterm infants whose mothers did not receive Tdap vaccination, Ag-specific memory B cell response to vaccination will be studied. For comparison of Ag-specific memory B cell development 25 healthy term infants and their mothers will also be recruited.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
145 Participants
are grouped into 2 trial groupsGroup A: preterm
Group B: healthy controls
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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.
Time frame
2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Maastricht University Medical Center
Lead sponsor
Medical Center Haaglanden
Collaborator
Amphia Hospital
Collaborator
Albert Schweitzer Hospital
Collaborator
Franciscus Gasthuis
Collaborator
Maasstad Hospital
Collaborator
Maxima Medical Center
Collaborator
Reinier de Graaf Groep
Collaborator
Erasmus Medical Center
Collaborator
Merck Sharp & Dohme LLC
Collaborator
Zuyderland Medical Centre
Collaborator
Haga Hospital
Collaborator
Source ClinicalTrials.gov