Tolerability, Safety, and Efficacy of Varicella-zoster-virus vaccination in immunosuppressed children with inflammatory bowel disease or autoimmunhepatitis

• Conditions: K50.1; K50.0; K51.0; K51.2; K51.3; K50.88; K51.9; K75.4; Crohn disease of large intestine; Crohn disease of small intestine

• Registration Number: DRKS00016357
• Lead Sponsor: Klinik für Kinder- und JugendmedizinUniversitätsklinikum Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-15
• Study Completion: 2020-02-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

As this is an observational study no inclusion criteria are defined. In principal, patients with chronic inflammatory bowel disease or autoimmune hepatitis being in steady state of their disease and having the indication of varicella vaccination due to insufficient protection against varicella can participate.

Exclusion Criteria

As this is an observational study no exclusion criteria are given for this study. Basically the recommendations from the enclosed leaflet have to be followed.
In addition, we made some recommendations in our observational protocol.
1) We need a parent or patient consent to collect and analyze the data in this study.
2) If the patient is suspicious for an immunodeficiency this should be clarified first.
3) In addition to the leaflet we do not recommend immunization during an active underlying disease
4) Furthermore, we specified some conditions that may affect safety and efficiency, which should be avoided. In detail these conditions are stated in the observational protocol.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of varicella vaccination using the immunological check list

Secondary Outcome Measures

Name	Time	Method
Effectivity of vaccination with increment of vaccine specific antibody formation after 12-16 weeks