Investigating immune system development and vaccination response in preterm infants
Preterm Immune System Development and Response to Immunization
This study looks at how very preterm infants respond to vaccinations compared to healthy full-term infants to see if their immune systems develop differently.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 145 (estimated) |
| Ages | 1 Day to 2 Months |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 7 sites (Breda and 6 other locations) |
| Trial ID | NCT05266664 on ClinicalTrials.gov |
What this trial studies
This observational study compares the immune system development and vaccination responses of very preterm infants (born at less than 32 weeks gestation) to those of healthy term infants. It aims to understand how preterm infants, who are at higher risk for infections due to an immature immune system, respond to routine vaccinations. The study will utilize various methodologies, including flow cytometry, ELISA, and single-cell transcriptomics, to assess antibody responses and the development of memory B cells. Additionally, it will explore the impact of maternal Tdap vaccination during pregnancy on these responses.
Who should consider this trial
Good fit: Ideal candidates include preterm infants born at less than 32 weeks gestation and healthy full-term infants whose mothers received Tdap vaccination during pregnancy.
Not a fit: Patients who may not benefit from this study include those with congenital anomalies that could affect immunization responses or those whose parents cannot provide informed consent.
Why it matters
Potential benefit: If successful, this study could enhance understanding of immune responses in preterm infants, potentially leading to improved vaccination strategies and better health outcomes.
How similar studies have performed: Other studies have shown varying success in understanding immune responses in preterm infants, but this specific approach focusing on vaccination response is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Breda and 6 other locations
- Amphia Hospital — Breda, Netherlands (Recruiting)
- reinier de Graaff Group — Delft, Netherlands (Recruiting)
- Albert Schweitzer Hospital — Dordrecht, Netherlands (Recruiting)
- Erasmus MC — Rotterdam, Netherlands (Recruiting)
- Franciscus Gasthuis — Rotterdam, Netherlands (Recruiting)
- Maasstad Hospital — Rotterdam, Netherlands (Recruiting)
- Maxima Medical Center — Veldhoven, Netherlands (Recruiting)
Study contacts
- Principal investigator: Jantien Bolt-Wieringa, MD — Medical Center Haaglanden
- Study coordinator: Gertjan Driessen, Prof MD PhD
- Email: gertjan.driessen@mumc.nl
- Phone: +31433876543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.