Preterm Immune System Development and Response to Immunization
NCT ID: NCT05266664
Last Updated: 2024-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
145 participants
OBSERVATIONAL
2022-12-08
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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preterm
preterm infants gestational age less than 32 weeks
No interventions assigned to this group
healthy controls
healthy term infants
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Parents/ guardians must have sufficient understanding of the Dutch language
To be eligible to participate in this study, a healthy full-term infant must meet all following criteria:
* healthy full-term infant whose mother received a Tdap vaccination during pregnancy
* Parents/ guardians must have sufficient understanding of the Dutch language
To be eligible to participate in this study, a mother must meet all following criteria:
\- Mother of preterm or health full-term infant who are participating in the study
Exclusion Criteria
* 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
1 Day
2 Months
ALL
Yes
Sponsors
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Medical Center Haaglanden
OTHER
Amphia Hospital
OTHER
Albert Schweitzer Hospital
OTHER
Franciscus Gasthuis
OTHER
Maasstad Hospital
OTHER
Maxima Medical Center
OTHER
Reinier de Graaf Groep
OTHER
Erasmus Medical Center
OTHER
Merck Sharp & Dohme LLC
INDUSTRY
Zuyderland Medical Centre
OTHER
Haga Hospital
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Gertjan Driessen, Prof MD PhD
Role: STUDY_DIRECTOR
Maastricht UMC
Jantien Bolt-Wieringa, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Center Haaglanden
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Ron Beek van, MD, PhD
Role: primary
Laura Meer-Kappelle van der, MD
Role: primary
Miranda Jong, de, MD, PhD
Role: primary
Rene Kornelisse, MD, PhD
Role: primary
Gerdien Tramper, MD, PhD
Role: primary
Martin Baartmans, MD, PhD
Role: primary
Jacqueline van der Sluijs-Bens, MD
Role: primary
References
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Collins A, Weitkamp JH, Wynn JL. Why are preterm newborns at increased risk of infection? Arch Dis Child Fetal Neonatal Ed. 2018 Jul;103(4):F391-F394. doi: 10.1136/archdischild-2017-313595. Epub 2018 Jan 30.
Heininger U, Riffelmann M, Leineweber B, Wirsing von Koenig CH. Maternally derived antibodies against Bordetella pertussis antigens pertussis toxin and filamentous hemagglutinin in preterm and full term newborns. Pediatr Infect Dis J. 2009 May;28(5):443-5. doi: 10.1097/INF.0b013e318193ead7.
van den Berg JP, Westerbeek EA, Berbers GA, van Gageldonk PG, van der Klis FR, van Elburg RM. Transplacental transport of IgG antibodies specific for pertussis, diphtheria, tetanus, haemophilus influenzae type b, and Neisseria meningitidis serogroup C is lower in preterm compared with term infants. Pediatr Infect Dis J. 2010 Sep;29(9):801-5. doi: 10.1097/inf.0b013e3181dc4f77.
Wilck MB, Xu ZJ, Stek JE, Lee AW. Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis) in premature infants. Hum Vaccin Immunother. 2021 Jan 2;17(1):191-196. doi: 10.1080/21645515.2020.1756668. Epub 2020 Aug 4.
Barug D, Pronk I, van Houten MA, Versteegh FGA, Knol MJ, van de Kassteele J, Berbers GAM, Sanders EAM, Rots NY. Maternal pertussis vaccination and its effects on the immune response of infants aged up to 12 months in the Netherlands: an open-label, parallel, randomised controlled trial. Lancet Infect Dis. 2019 Apr;19(4):392-401. doi: 10.1016/S1473-3099(18)30717-5. Epub 2019 Mar 27.
Syed YY. DTaP5-HB-IPV-Hib Vaccine (Vaxelis(R)): A Review of its Use in Primary and Booster Vaccination. Paediatr Drugs. 2017 Feb;19(1):69-80. doi: 10.1007/s40272-016-0208-y.
Vono M, Eberhardt CS, Auderset F, Mastelic-Gavillet B, Lemeille S, Christensen D, Andersen P, Lambert PH, Siegrist CA. Maternal Antibodies Inhibit Neonatal and Infant Responses to Vaccination by Shaping the Early-Life B Cell Repertoire within Germinal Centers. Cell Rep. 2019 Aug 13;28(7):1773-1784.e5. doi: 10.1016/j.celrep.2019.07.047.
Other Identifiers
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NL80118.068.22
Identifier Type: -
Identifier Source: org_study_id
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