Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

Karolinska University Hospital

Status: Withdrawn

Conditions: Tuberculosis; Hepatitis A; Hepatitis B; Cystic Fibrosis

Treatments: Biological: Vaccination with vaccine against hepatitis A and B

Study type: Interventional

Funder types: Other

Identifiers

NCT02605538

2012/251-31/2

Details and patient eligibility

About

CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients according to European consensus. The aim of the study is to vaccinate as many patients as possible and to follow up whether immunization has been complete.

Full description

Initially, healthy volunteers will be vaccinated to be compared with patients' antibody response to hepatitis A and B vaccine.

The connected part of this study is to vaccinate children suffering from latent tuberculosis against hepatitis B and to measure whether the immunization is related to specific interferon gamma response against Mycobacterium tuberculosis.

Sex: All

Ages: 1+ year old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• CF patients not previously immunized against hepatitis A or B
• Healthy volunteers not previously immunized against hepatitis A or B
• Age over 1 year

Exclusion criteria

• Previously transplanted patients
• Previous vaccination with hepatitis vaccine
• Known allergy against components in Twinrix (TM)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Cystic Fibrosis

Active Comparator group

Description:

Vaccination with Twinrix (TM), 3 doses within 6 months according to the manufacturer's instruction. The response will be studied in a time frame of 6 months.

Treatment:

Biological: Vaccination with vaccine against hepatitis A and B

Healthy volunteers

Active Comparator group

Description:

Vaccination with Twinrix (TM), 3 doses within 6 months according to the manufacturer's instruction. The response will be studied in a time frame of 6 months.

Treatment:

Biological: Vaccination with vaccine against hepatitis A and B