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NCT Number: NCT05266664

Preterm Immune System Development and Response to Immunization

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.

Recruiting

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Key information

Conditions

Immune System Disorder Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Urogenital Diseases Vaccination Failure

Age range

1 day–2 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Amphia Hospital, Breda, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

To be eligible to participate in this study, a preterm infant must meet all following criteria:

  • 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

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

  • 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

Treatment and study plan

Primary outcomes

  1. antibody immune response to routine vaccinations in very preterm infants

    Time frame: 6 months

    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.

Secondary outcomes

  1. IgG antibody concentrations following booster of routine vaccination with Vaxelis

    Time frame: 12 months

    IgG antibody concentrations against vaccine antigens in preterm-born infants following booster of routine vaccination with Vaxelis.

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

    Time frame: 6 and 12 months

    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.

  3. IgG antibody concentrations 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 vaccine antigens in preterm-born infants following routine vaccinations with 10-valent pneumococcal conjugate vaccine after primary series and booster vaccination.

  4. 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.

    Time frame: 2 months

    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.

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

    Time frame: 6 and 12 months

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

  6. IgG antibody concentrations in relation to maternal antibody concentrations against vaccine antigens

    Time frame: birth, 2,6 and 12 months

    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

  7. comparison of response to vaccination between preterm infants and healthy term infants

    Time frame: 6 and 12 months

    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.

  8. Comparison of number of antigen-specific memory B cells in cells/microliter with and without preceding maternal Tdap vaccination

    Time frame: 6 and 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gertjan Driessen, Prof MD PhD

CONTACT

[email protected]

+31433876543

Jantien Bolt-Wieringa, MD

CONTACT

[email protected]

+310889792330

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Albert Schweitzer Hospital
  • Amphia Hospital
  • Erasmus Medical Center
  • Franciscus Gasthuis
  • Haga Hospital
  • Maasstad Hospital
  • Maxima Medical Center
  • Medical Center Haaglanden
  • Merck Sharp & Dohme LLC
  • Reinier de Graaf Groep
  • Zuyderland Medical Centre

Registry information

Acronym: PRIMI

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 4, 2022
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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