The 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-…
ID
Bron
Verkorte titel
Aandoening
Hepatitis B vaccine
Children born to IBD mothers
Inflammatory Bowel Disease
Anti-TNF
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
anti-HBs levels 4 weeks after last inoculation for HBV
Achtergrond van het onderzoek
Some 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.
Doel van het onderzoek
The 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.
Onderzoeksopzet
venous blood sample will be drawn 4 weeks after the final inoculation for HBV (when the child is approximately 12 months old)
Onderzoeksproduct en/of interventie
-
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A 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’
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4386 |
| NTR-old | NTR4517 |
| Ander register | NL47460.078.13 : MEC-2014-011 |