No registrations found.
ID
Source
Brief title
Health condition
Hepatitis B vaccine
Children born to IBD mothers
Inflammatory Bowel Disease
Anti-TNF
Sponsors and support
Intervention
Outcome measures
Primary outcome
anti-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
Background summary
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.
Study objective
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.
Study design
venous blood sample will be drawn 4 weeks after the final inoculation for HBV (when the child is approximately 12 months old)
Intervention
-
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 criteria
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’
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4386 |
| NTR-old | NTR4517 |
| Other | NL47460.078.13 : MEC-2014-011 |