💬In plain words
What the trial is, and whether it could suit you
Herpes zoster (HZ) is a serious health problem whose incidence and severity increase with the decline of cell-mediated immunity (CMI) because of age and immunocompromised (IC) status. Subclinical reactivation are described and may boost the adaptive specific immunity. T cells play a major role in preventing reactivation of Varicella Zoster virus (VZV), with a contribution of both CD4 and CD8 T cells. Accordingly, the suppression of VZV-specific T cells preceded the occurrence of HZ. Moreover, several observations support a role of B cells in contributing to the overall protection against HZ as patients with primary antibody deficiency, common variable immunodeficiency, or patients treated with B-cell depleting therapies or Janus Kinase inhibitors (JAKis) show a higher risk of HZ. The functional effectiveness of CMI can be significantly affected by different diseases (e.g. cancer and immu
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
3.1.1. Adult population (longitudinal study) General inclusion criteria Age ≥ 18 years Eligibility for RZV vaccination Written informed consent
Inclusion criteria for specific sub-groups:
Rheumatologic patients:
* rheumatoid arthritis diagnosis according to classification criteria of 1987 and/or 2018
* eligibility or in therapy with JAKis o CTLA4-Ig (monotherapy or DMARD combination)
Oncologic patients:
* confirmed histological diagnosis of solid tumour (any type)
* life expectancy ≥ 6 months
* Patients with cancer who have to start immunotherapy with or without chemotherapy/targeted therapy
Hematologic patients:
* Patients with haematological malignancy treated with drugs (chemotherapy, new drugs, target therapies) other than antibodies.
* Patients treated with anti-CD19 or CD20 or CD22 or CD30 or anti-PD1 antibodies with or without chemotherapy
* Patients receiving autologous or allogeneic transplantation or CAR-T cells
Neurologic patients:
* Multiple sclerosis (MS) diagnosis according to McDonald criteria 2017
* Eligibility or in therapy with first- or second-line immunosuppressive treatments
General Exclusion criteria No informed consent Previous HZ vaccination Documented reactions or allergies against vaccines Severe infections during the previous 3 months
3.1.2. Pediatric population (cross-sectional study) Inclusion criteria Written informed consent from parents legal tutor and child assent (depending on age) Serology for VZV positive
Hematologic patients:
* Patients with haematological malignancies treated with chemotherapy including experimental drugs and target therapies;
* Patients with haematological malignancies undergoing B-cell depleting treatments, e.g. CAR-T cell therapy or anti-CD20, antiCD22, anti-CD30, anti-CD19 monoclonal or bispecific antibodies
* Patients with haematological malignancies receiving allogeneic transplantation due to malignant or non-malignant diseases, including primary immunodeficiencies, hemoglobinopathies and acquired or inherited bone marrow failure syndrome.
Rheumatologic patients:
1. patients with connective tissue diseases (including systemic lupus erythematosus, SLE, juvenile dermathomyositis, JDM, and scleroderma) treated with B cell depleting therapies (anti-CD20);
2. patients with juvenile idiopathic arthritis (JIA) treated with TNF inhibitors. The corresponding disease control populations will be patients with the same diseases listed above, who are not receiving anti-CD20 or TNF inhibitors, respectively.
Fondazione IRCCS Policlinico San Matteo, SC Microbiologia e Virologia
Pavia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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