Preterm Immune System Development and Response to Immunization

NCT05266664 | Recruiting

• 1 other identifier: NL80118.068.22
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Immune System Disorder; Preterm; Vaccination Failure

Keywords

immune system development; preterm infant; vaccination

Outcome Measures

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.

  6 months

Secondary Outcomes (8)

• IgG antibody concentrations following booster of routine vaccination with Vaxelis

  12 months

• geometrical mean concentrations following primary series and booster of routine vaccination with Vaxelis.

  6 and 12 months

• IgG antibody concentrations following routine vaccinations with 10-valent pneumococcal conjugate vaccine after primary series and booster vaccination.

  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.

  2 months

• number of antigen-specific memory B cells in cells/microliter following routine vaccinations after primary series and booster vaccination

  6 and 12 months

Study Arms (2)

preterm

preterm infants gestational age less than 32 weeks

healthy controls

healthy term infants

Eligibility Criteria

• Age: 1 Day - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• 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

Study Sites (7)

Amphia Hospital

Breda, 4819 EV, Netherlands

RECRUITING

reinier de Graaff Group

Delft, 2625 AD, Netherlands

RECRUITING

Albert Schweitzer Hospital

Dordrecht, 3318 AT, Netherlands

RECRUITING

Erasmus MC

Rotterdam, 3015 GD, Netherlands

RECRUITING

Franciscus Gasthuis

Rotterdam, 3045 PM, Netherlands

RECRUITING

Maasstad Hospital

Rotterdam, 3079 DZ, Netherlands

RECRUITING

Maxima Medical Center

Veldhoven, 5504 DB, Netherlands

RECRUITING

Related Publications (7)

• 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.

  PMID: 29382648 BACKGROUND

• 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.

  PMID: 19319020 BACKGROUND

• 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.

  PMID: 20803841 BACKGROUND

• 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.

  PMID: 32750261 BACKGROUND

• 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.

  PMID: 30938299 BACKGROUND

• 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.

  PMID: 28035545 BACKGROUND

• 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.

  PMID: 31412246 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white blood cells, stools

MeSH Terms

Conditions

Immune System Diseases; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Gertjan Driessen, Prof MD PhD

  Maastricht UMC

  STUDY DIRECTOR

• Jantien Bolt-Wieringa, MD

  Medical Center Haaglanden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gertjan Driessen, Prof MD PhD

CONTACT

+31433876543; gertjan.driessen@mumc.nl

Jantien Bolt-Wieringa, MD

CONTACT

+310889792330; j.boltwieringa@haaglandenmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 4, 2022
• Study Start: December 8, 2022
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

NL (7)