Multidisciplinary Hospital-Territory Vaccine Center: a Model for Achieving the Herpes Zoster Vaccine Coverage

NCT06334861 | Completed

• 1 other identifier: 5001
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

The National Vaccination Program, updated by the Ministry of Health in 2021, provides a new vaccination opportunity for frail patients against Herpes zoster virus (HZ). The new treatment option, on the other hand, is designed by combining VZV-specific antigen (gE) with an adjuvant system (AS01B) to induce antigen-specific cellular and humoral immune responses in individuals with preexisting immunity to VZV. Efficacy, assessed in people given two doses 2 months apart, is around 97% in those aged 50 years and 91% in those over 70 years. In the studies conducted, HZ-related hospitalizations were significantly reduced. The vaccine schedule calls for the administration of two doses 2 months apart. The current HZ Vaccination Program implemented at the regional level recommends its active and free offer in people from 18 years of age with congenital and/or acquired immunodepression, through a collaborative relationship involving, on the one hand, multispecialist and multiprofessional medical staff and, on the other hand, citizens called to play a role that is no longer passive but the subject of empowerment by consciously making their own health choices. The collaboration with ASL Roma1, in this sense, acquires value as guarantor of the supply of the adjuvanted recombinant anti-HZ vaccine and of the appropriate reporting of vaccination coverage, which to date is still far from the targets set by the PNPV'17-'19 in adults at risk for disease. The purpose of this study Single-center prospective longitudinal observational cohort study is to verify patients' compliance with the proposed vaccination, the effectiveness of counseling carried out by a multidisciplinary team in the hospital setting.

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• Compliance to vaccination

  Patients' compliance with the vaccination proposal, in terms of the number of patients vaccinated compared with the total number of subjects eligible for vaccination and afferent to the participating OUs in the project

  12 months

Study Arms (1)

Fragile patients vaccinated with herpes zoster vaccine

Patients with immunodeficiency and/or immunosuppression afferent to the U.O.C. Rheumatology, U.O.C. Hematology and Hematopoietic Stem Cell Transplantation, U.O.C. Infectious Diseases and Geriatric Internal Medicine, Travel Clinic and Occupational Health Outpatient Clinic of FPU Agostino Gemelli IRCCS who meet the inclusion criteria will be recruited. Inclusion Criteria. * Patients with congenital and/or acquired immunodepression; * Age \> 18 years; * Signature of informed consent Exclusion criteria. * Persons younger than 18 years of age

Biological: Herpes Zoster adjuvanted recombinant vaccine

Interventions

Herpes Zoster adjuvanted recombinant vaccine BIOLOGICAL

patients will receive two doses of vaccine with an interval between the first and second dose of 2 months

Fragile patients vaccinated with herpes zoster vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Since this is a large-scale observational real-life study, and given the purely exploratory primary endpoint, formal sample sizing is not necessary. However, based on the data available from the referral departments for the past year, it is estimated to include, among the immunocompromised subjects covered by the recommendation to the anti-HZ vaccine campaign: 50 HIV+ patients, 50 onco-hematology subjects, 50 immunocompromised rheumatology subjects, 50 frail geriatric patients, and 50 patients from the Travel Clinic and Occupational Health Outpatient Clinic for a total of 250 patients. These numbers may be higher or lower depending on the supply of vaccine doses by ASL Roma 1.

You may qualify if:

• Patients with congenital and/or acquired immunodepression;
• Age \> 18 years;
• Signature of informed consent

You may not qualify if:

• Persons younger than 18 years of age
• Pregnancy and lactation
• Hypersensitivity to the active ingredients and excipients in the formulation
• Refusal to sign informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli - UCSC

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Patrizia Laurenti

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 28, 2024
• Study Start: June 23, 2022
• Primary Completion: May 15, 2024
• Study Completion: July 30, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)