Hepatitis B vaccine efficacy in children exposed to anti-TNF in utero

Recruiting

• Conditions: werkzaamheid hepatitis B vaccinatie; Crohn's disease; ulcerative colitis; 10017969; 10036411

• Registration Number: NL-OMON40615
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Study group: IBD mother must be treated with anti-TNF (infliximab or adalimumab) during (part of) the pregnancy
- Control group: IBD mother not treated with anti-TNF (any other IBD medication)
- Live birth

Exclusion Criteria

- incapacity to understand the informed consent
- Maternal HBV, HCV or HIV infection
- Other immunecompromising conditions in the child
- not intending to vaccinate child according to the Dutch National Vaccination Programme in Dutch: *Nederlandse Rijksvaccinatieprogramma*

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Antibodies to the hepatitis B surface antigen (anti-HBs) 30 days after the<br /><br>final HBV vaccination at 11 months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- (if applicable) anti-HBs levels 4 weeks after HBV booster vaccination in the<br /><br>primary non-immune children<br /><br>- Anti-TNF levels from the cord blood, and if required when the child is 3<br /><br>months old, 6 months old and 12 months old.<br /><br>- Maternal anti-TNF levels at delivery</p><br>