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Immune System DisorderPRIMINCT05266664

Preterm Immune System Development and Response to Immunization

An observational study of Immune System Disorder and Preterm, run by Maastricht University Medical Center at 7 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 day to 2 monthsHealthy volunteers can take part
How many people
145 participants
Where
7 sitesNetherlands
Study dates
8 Dec 2022to Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 2 months
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

None listed.

Who cannot join

  • 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 locations and contacts

7 sites in 1 country.

Gertjan Driessen, Prof MD PhD contact

+31433876543

gertjan.driessen@mumc.nl

Jantien Bolt-Wieringa, MD contact

+310889792330

j.boltwieringa@haaglandenmc.nl

7 sites in 1 country

Netherlands7 sites, 7 recruiting

  • Amphia Hospital

    Breda, 4819 EV

    Ron Beek van, MD, PhD, +31(0)76-5951012

    Recruiting

  • reinier de Graaff Group

    Delft, 2625 AD

    Laura Meer-Kappelle van der, MD, +31(0)15 2603060

    Recruiting

  • Albert Schweitzer Hospital

    Dordrecht, 3318 AT

    Miranda Jong, de, MD, PhD, +31(0)78-654 11 11

    Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD

    Rene Kornelisse, MD, PhD, +31(0)107036104

    Recruiting

  • Franciscus Gasthuis

    Rotterdam, 3045 PM

    Gerdien Tramper, MD, PhD, +31(0)10 4616225

    Recruiting

  • Maasstad Hospital

    Rotterdam, 3079 DZ

    Martin Baartmans, MD, PhD, +31(0)102911911

    Recruiting

  • Maxima Medical Center

    Veldhoven, 5504 DB

    Jacqueline van der Sluijs-Bens, MD, +31(0)408880000

    Recruiting

Other trials in Netherlands

About this study

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.

Read the detailed description

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.

Keywords
immune system development, preterm infant, vaccination
Medical subject headings
Immune System Diseases, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05266664
Study groupRoleWhat they receive
pretermpreterm infants gestational age less than 32 weeks
healthy controlshealthy term infants

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (8)

  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.

    Measured: 12 months

  2. 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.

    Measured: 6 and 12 months

  3. 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.

    Measured: 6 and 12 months

  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.

    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.

    Measured: 2 months

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

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

    Measured: 6 and 12 months

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

    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

    Measured: birth, 2,6 and 12 months

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

    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.

    Measured: 6 and 12 months

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

    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.

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start8 Dec 2022
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
145 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05266664
Sponsor's protocol ID
NL80118.068.22
Acronym
PRIMI
Status last verified
Mar 2024
First submitted
11 Feb 2022
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29382648

  • 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.

    PubMed 19319020

  • 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.

    PubMed 20803841

  • 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.

    PubMed 32750261

  • 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.

    PubMed 30938299

  • 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.

    PubMed 28035545

  • 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.

    PubMed 31412246

Questions about this trial

What is this clinical trial studying?

An observational study of Immune System Disorder and Preterm, run by Maastricht University Medical Center at 7 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gertjan Driessen, Prof MD PhD (+31433876543, gertjan.driessen@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

antibody immune response to routine vaccinations in very preterm infants (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05266664, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

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