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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40615

Enrollment

Registered

2014-04-14

Start date

2014-05-22

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

werkzaamheid hepatitis B vaccinatie Crohn's disease ulcerative colitis

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

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*

Design outcomes

Primary

Measure	Time frame
- Antibodies to the hepatitis B surface antigen (anti-HBs) 30 days after the final HBV vaccination at 11 months	—

Secondary

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

Countries

Netherlands

Outcome results