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De effectiviteit van het hepatitis B vaccin bij kinderen geboren uit moeders met een inflammatoire darmziekte die anti-TNF hebben gebruikt tijdens de zwangerschap


- candidate number17496
- NTR NumberNTR4517
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-apr-2014
- Secondary IDsMEC-2014-011 NL47460.078.13
- Public TitleDe effectiviteit van het hepatitis B vaccin bij kinderen geboren uit moeders met een inflammatoire darmziekte die anti-TNF hebben gebruikt tijdens de zwangerschap
- Scientific TitleHBV vaccine efficacy in children exposed to anti-TNF in utero
- ACRONYMHEFFIC study
- hypothesisThe hypothesis is that children who are exposed to anti-TNF during pregnancy, and who are subsequently born with significant anti-TNF levels detectable until at least 3 months of age, will insufficiently generate an adequate immune response (anti-HBs) to the hepatitis B vaccine.
- Healt Condition(s) or Problem(s) studiedHepatitis B vaccine, IBD, Inflammatory bowel disease, Newborns
- Inclusion criteria- Study group: children born to IBD mothers treated with anti-TNF (infliximab or adalimumab) during (part of) the pregnancy
- Control group: children born to IBD mothers not treated with anti-TNF (any other IBD medication)
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
- incapacity to understand the informed consent
- Maternal HBV, HCV or HIV infection
- Other immune-compromising conditions in the child
- Not intending to vaccinate child according to the Dutch National Vaccination Programme in Dutch: ‘Nederlandse Rijksvaccinatieprogramma’
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 15-apr-2014
- planned closingdate1-apr-2017
- Target number of participants24
- Interventions-
- Primary outcomeanti-HBs levels 4 weeks after last inoculation for HBV
- Secondary outcome(if required) anti-HBs levels after HBV booster vaccine in case of primary non-immunity
- Timepointsvenous blood sample will be drawn 4 weeks after the final inoculation for HBV (when the child is approximately 12 months old)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. A. Lima, de
- CONTACT for SCIENTIFIC QUERIESDrs. A. Lima, de
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications-
- Brief summarySome women with Inflammatory Bowel Disease (IBD) will require anti-TNF treatment during pregnancy. Anti-TNF actively crosses the placenta from the mother to the fetus, resulting in clinically significant anti-TNF levels in the child, detectable until 6 months of age. There is some evidence that adult patients treated with anti-TNF have inadequate response to the hepatitis B (HBV) vaccine, which leads to non-immunity. We propose to investigate the response to the HBV vaccine of children exposed to anti-TNF in utero.
- Main changes (audit trail)
- RECORD15-apr-2014 - 19-mei-2014


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