Vaccination with herpes zoster subunit vaccineLiver cirrhosisOrgan transplantationImmunosuppression
Conditions
Interventions
Group 1: Liver cirrhosis Child A or B
Group 2: Liver transplantation
Group 3: 60-70 (max. 75) years-old control group without immunocompromising disease or immunosuppressive therapy.
Sponsors
Institut für Allgemeinmedizin des Universitätsklinikums Essen
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients of the liver transplant outpatient clinic of the University Medical Center Essen, who have liver cirrhosis Child A or B or have undergone liver transplantation and are older than 50 years. Immunocompetent control group: patients without a chronic disease mentioned in the exclusion criteria and without immunosuppression with medication, who are 60-70 (max. 75) years old.
Exclusion criteria
Exclusion criteria: Varicella seronegativity, previous vaccination with Shingrix® or Zostavax®, acute liver failure, drug immunosuppression in patients with chronic liver cirrhosis, liver transplantation less than six months ago, lack of knowledge of German or inability to translate, allergy to one of the components of the Shingrix® vaccine, life expectancy <6 months, pregnancy, HIV infection. Immunocompetent control group additionally in the presence of at least one of the following diseases/circumstances: rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, chronic kidney disease, chronic obstructive pulmonary disease (COPD), bronchial asthma, diabetes mellitus, congenital or acquired immunodeficiency or immunosuppression/medical immunosuppression (e.g. cortisone as tbl. or i.v., methotrexate (MTX®), leflunomide (Arava®)), HIV infection, chronic alcohol addiction, chronic liver disease or condition after hepatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigation of the responsiveness of the immune system, depending on the type and strength of immunosuppression, after vaccination with an adjuvanted herpes zoster subunit vaccine by gE-VZV antibody determination. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Investigation of the responsiveness of the immune system, depending on the type and strength of immunosuppression, after vaccination with an adjuvanted herpes zoster subunit vaccine by T-cell analysis. b) To investigate whether there is a correlation between the measured gE-VZV-Antibody titer level and a) the severity of possible vaccination reactions and b) clinical vaccination protection (non-occurrence of herpes zoster or severe course). | — |
Countries
Germany
Contacts
Public ContactDorothea Dehnen
Institut für Allgemeinmedizin des Universitätsklinikums Essen
Outcome results
None listed