Immunogenicity, Efficacy and Safety of Recombinant Herpes Zoster Vaccine (RZV) in Frail Patients: Multicentric Prospective Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Objective: To define the overall rate of humoral responders patients after the second dose of RZV administration. Primary Endpoint: The rate of humoral responders will be defined as the percentage of patients showing ≥ 4 times of gE-specific IgG response (IU/mL) after the second dose (T1m) respect to baseline (T0) Secondary Objective 2.1: To define the overall increase of humoral response after the second dose of RZV administration. Secondary Objective 2.2: To characterize the immunogenicity induced by RZV vaccine in the different study cohorts (rheumatologic, oncologic, neurologic and hematologic patients) Secondary Objective 2.3: To evaluate the kinetics of humoral response during the first year after the vaccination Secondary Objective 2.4: To characterize gE-specific T cell mediated response elicited by RZV vaccination in overall patients Secondary Objective 2.5: Evaluation of the incidence of adverse reactions (AR) to the RZV vaccine, local and systemic, solicited and unsolicited, within the period of four weeks after the second dose of RZV. Secondary Objective 2.6: Evaluation of the incidence of reactivation of VZV cases after the second dose of RZV.

Eligibility
Participation Requirements
Sex: All
View:

⁃ 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

Locations
Other Locations
Italy
Fondazione IRCCS Policlinico San Matteo, SC Microbiologia e Virologia
RECRUITING
Pavia
Contact Information
Primary
Fausto Baldanti, MD
f.baldanti@smatteo.pv.it
+390382501039
Time Frame
Start Date: 2023-05-16
Estimated Completion Date: 2027-05
Participants
Target number of participants: 300
Sponsors
Leads: Fondazione IRCCS Policlinico San Matteo di Pavia

This content was sourced from clinicaltrials.gov

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