Evidence on serological responses to vaccination in children exposed to ustekinumab (UST) or vedolizumab (VDZ) in utero is lacking. This multicentre prospective study aimed to assess the impact of prenatal exposure to UST or VDZ due to maternal inflammatory bowel disease (IBD) on serological responses to vaccination and other immunological parameters in exposed children. Children aged ≥ 1 year who were exposed in utero to UST or VDZ and completed at least 1-year of mandatory vaccination were included. We assessed the serological response to vaccination (non-live: tetanus, diphtheria, and Haemophilus influenzae B; live: mumps, rubella, and measles), whole blood count, and immunoglobulin levels. The control group comprised unexposed children born to mothers without IBD. A total of 23 children (median age, 25 months) exposed to UST (n = 13) or VDZ (n = 10) and 10 controls (median age, 37 months) were included. The serological response to vaccination was comparable between the UST and VDZ groups and controls, with an adequate serological response rate of ≥ 80%. Only children exposed to UST showed a slightly reduced serological response to mumps (67% vs. 86% in controls), whereas all children exposed to VDZ showed an adequate response. The majority of the exposed children had normal levels of individual immunoglobulin classes, similar to the controls. No severe pathology was observed in any of the children.Conclusion: Despite the limited sample size, our findings suggest that in utero exposure to VDZ or UST does not significantly impair the vaccine response or broader immunological parameters in exposed children.

2nd Department of Internal Medicine Gastroenterology and Geriatrics Faculty of Medicine and Dentistry Palacky University and University Hospital Olomouc Czech Republic

Department of Children and Adolescents 3rd Faculty of Medicine Charles University and University Hospital Kralovske Vinohrady Prague Czech Republic

Department of Internal Medicine Jihlava Hospital Jihlava Czech Republic

Department of Medicine 1st Faculty of Medicine Charles University and Military Hospital Military University Hospital Prague Prague Czech Republic

Department of Pediatrics 2nd Faculty of Medicine Charles University Prague and Motol University Hospital 5 Uvalu 84 150 06 Prague Czech Republic

Department of Pharmacology 1st Faculty of Medicine Charles University Prague Czech Republic

Digestive Diseases Centre Hospital AGEL Vitkovice Ostrava Czech Republic

GENNET s r o Prague Czech Republic

IBD Clinical and Research Centre ISCARE a s Prague Czech Republic

Private practice of General Pediatrician Prague Czech Republic

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