Efficacy of Zoster Vaccination in Glioblastoma Patients

Exclusion Criteria

• •Subjects not able to give consent
• •Subject without legal capacity who is unable to understand the nature, scope, significance, and con- sequences of this clinical trial
• •Simultaneously participation in another clinical trial or participation in any clinical trial involving ad- ministration of an investigational medicinal product within 30 days prior to clinical trial beginning
• •Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk may confound the trial results or may interfere with the subject's participation in this clinical trial
• •Known or persistent abuse of medication, drugs or alcohol
• •Contraindications for radiotherapy (including active inflammatory disease)
• •Known hypersensitivity against vaccine contra herpes zoster, or its constituents
• •Gliomatosis cerebri at time of enrollment on any imaging or proved by histopathology
• •Synchronous secondary malignancy
• •Current or planned pregnancy or nursing women
• •Females of child-bearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contracep- tives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
• •Primary infra-tentorial located glioblastoma (justification: specific subgroup of patients with different prognosis)
• •Significant comorbidities at baseline, which would prevent possible chemotherapy, including:
• •i. Platelet count \< 100/nl ii. Absolute neutrophil count (ANC) \< 1.5/nl iii. AST or ALT \> 3 times the upper limit of normal iv. Total bilirubin above the normal range v. Serum creatinine \> 1.7 mg/dl
• •Patients with clinically significant liver-, renal- or blood disorder
• •Patients with known additional significant neurological disease (e.g. primary seizure disorder\*, de-mentia, progressive degenerative neurological disease, meningitis or encephalitis, hydrocephalus with increased intracranial pressure)
• •Patients with brain tumor-related epilepsy, seizure-free under antiepileptic therapy are eligible
• •Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators and programmable shunts) or documented clinically signifi- cant arrhythmias
• •History of HIV infection