Why are preterm newborns at increased risk of infection?
Amélie Collins, Jörn-Hendrik Weitkamp, James L Wynn
https://pubmed.ncbi.nlm.nih.gov/29382648Actively Recruiting
Age: 1Day - 2Months
All Genders
Healthy Volunteers
ID05266664
Preterm Immune System Development and Response to Immunization
Led by Maastricht University Medical Center · Updated on 2024-03-20
145
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
M
Medical Center Haaglanden
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the immune system development and vaccination response in very preterm infants born before 32 weeks of gestation compared to healthy full-term infants. This study focuses on how well preterm infants respond to routine vaccinations, given their increased risk of infections and lower maternal antibody protection at birth. The research aims to better understand the antibody and antigen-specific memory B cell responses, which are important for immune function in early life. The study observes two groups: very preterm infants and healthy term infants whose mothers received Tdap vaccination during pregnancy. It involves monitoring the immune responses to routine vaccinations at several time points up to 12 months of age. Advanced laboratory techniques such as flow cytometry, ELISA, single-cell transcriptomics, proteomics, epigenetics, and microbiome studies are used to analyze immune system development and function. Participants will be followed from birth through routine vaccination schedules with assessments at birth, 2, 6, and 12 months. Researchers will measure antibody levels, antigen-specific memory B cells, and compare responses between preterm and full-term infants. The study also examines the impact of maternal vaccination on infant immune responses. Long-term monitoring includes evaluating booster vaccine responses and antibody concentrations to assess immune system maturity and function over time.
CONDITIONS
Brief Title
Preterm Immune System Development and Response to Immunization
Who Can Participate
Age: 1Day - 2Months
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Preterm infant born before 32 weeks gestational age (mothers may or may not have received Tdap vaccination during pregnancy)
- Healthy full-term infant whose mother received Tdap vaccination during pregnancy
- Parents or guardians must have sufficient understanding of the Dutch language
- Mothers of preterm or healthy full-term infants participating in the study
You will not qualify if you...
- Parents or guardians unable or unwilling to provide informed consent
- Infant with congenital anomalies likely to cause adverse effects after immunization (e.g., significant congenital heart defect)
- Infant with possible HIV infection or immunodeficiency
- Maternal use of immunosuppressive drugs during pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - From birth up to 12 months
Participants are observed to assess immune system development and response to routine vaccinations, including antibody and memory B cell responses.
Visits at birth, 2 months, 6 months, and 12 months
Trial Site Locations
Total: 7 locations
1
Amphia Hospital
Breda, Netherlands, 4819 EV
Actively Recruiting
2
reinier de Graaff Group
Delft, Netherlands, 2625 AD
Actively Recruiting
3
Albert Schweitzer Hospital
Dordrecht, Netherlands, 3318 AT
Actively Recruiting
4
Erasmus MC
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
5
Franciscus Gasthuis
Rotterdam, Netherlands, 3045 PM
Actively Recruiting
6
Maasstad Hospital
Rotterdam, Netherlands, 3079 DZ
Actively Recruiting
7
Maxima Medical Center
Veldhoven, Netherlands, 5504 DB
Actively Recruiting
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Research Team
G
Gertjan Driessen, Prof MD PhD
J
Jantien Bolt-Wieringa, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Maternally derived antibodies against Bordetella pertussis antigens pertussis toxin and filamentous hemagglutinin in preterm and full term newborns.
Ulrich Heininger, Marion Riffelmann, Birgit Leineweber...
https://pubmed.ncbi.nlm.nih.gov/19319020Transplacental 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.
Jolice P van den Berg, Elisabeth A M Westerbeek, Guy A M Berbers...
https://pubmed.ncbi.nlm.nih.gov/20803841Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis™) in premature infants.
Marissa B Wilck, Z Jin Xu, Jon E Stek...
https://pubmed.ncbi.nlm.nih.gov/32750261Maternal 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.
Daan Barug, Inge Pronk, Marlies A van Houten...
https://pubmed.ncbi.nlm.nih.gov/30938299DTaP5-HB-IPV-Hib Vaccine (Vaxelis®): A Review of its Use in Primary and Booster Vaccination.
Yahiya Y Syed
https://pubmed.ncbi.nlm.nih.gov/28035545Maternal Antibodies Inhibit Neonatal and Infant Responses to Vaccination by Shaping the Early-Life B Cell Repertoire within Germinal Centers.
Maria Vono, Christiane Sigrid Eberhardt, Floriane Auderset...
https://pubmed.ncbi.nlm.nih.gov/31412246