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临床试验/NCT06334861
NCT06334861招募中不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年6月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1
主要终点
Compliance to vaccination

研究概览

简要总结

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.

详细描述

Vaccinations are a safe and effective means of protecting populations against specific infectious diseases and are recommended at all ages. The implementation of Vaccine Services also goes through the introduction of new modes of delivery, with pathways increasingly suitable to promote and implement the prevention campaign. The Hospital represents the place par excellence where categories of at-risk individuals are intercepted for whom adequate vaccine protection is a priority. A Hospital Vaccine Center (CVO), therefore, could effectively select patients/users in both a programmed and an opportunity and initiative medicine perspective, putting in place the national and regional indications that would like to integrate the vaccine offer with the clinical care pathways of at-risk categories that belong to different disciplines. In line with these provisions of the Ministry of Health and the Lazio Region, the CVO is also proposed as a referral structure for the immunization of patients with high clinical complexity in order to achieve optimization, personalization and compliance with the vaccine program of individuals at higher risk, who, due to underlying diseases or ongoing treatments, need monitoring of the antibody response and have an indication to be vaccinated in a protected environment.

In concert with a forward-looking vision of "Hospital as a Vaccine Care and Prevention Center," the optimal vaccination pathway should be built in collaboration with the territorial reality, becoming a strategic-cultural continuum of promoting vaccination both as individual protection of frail adults and as a solidaristic choice in the interest of the entire community. So, our project is proposed as an organizational synergy between the I.R.C.C.S. Policlinico Universitario A. Gemelli and ASL Roma 1 (relying on the agreement stipulated between ASL Roma 1 and Policlinico Gemelli Foundation, regarding the supply of vaccines), thus ensuring cultural confrontation between hygienists and specialists involved in the care of frailty, constituting a scientific training network of professionals dedicated to counseling and for the drafting of vaccine protocols dedicated to the various conditions of interest.

The Strategic Advisory Group of Experts (SAGE) of the World Health Organization (WHO) defines "vaccine hesitation" as a delay in acceptance or refusal of vaccination despite vaccine availability. In any case, it appears mandated to put in place all interventions aimed at raising awareness of the benefits of vaccination, counteracting misinformation, fears, and reticence. The strategic value of the "Hospital Vaccine Center" model-pilot is inherent in offering the best and most appropriate immunological prophylaxis, being able to seize the right time (with respect to clinical-diagnostic and therapeutic-surgical follow-ups), place and time most effective for both the user and the specialist, managing patient care, promoting technological and scientific innovativeness, collecting and generating data (immunogenicity, efficacy, safety, compliance) and integrated "vaccine therapy-prevention" operational protocols, all in a real-world setting in specific fragile populations. All this is done by leveraging the specialist-patient fiduciary relationship and facilitating the vaccine culture pathway that sees vaccine delivery integrated with patient care activities.

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.

Primary endpoint of the study is to verify patients' compliance to the vaccination proposal, in terms of the number of patients vaccinated compared to the total number of subjects eligible for vaccination and afferent to the participating OUs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Herpes Zoster adjuvanted recombinant vaccine (Biological)

结局指标

主要结局

Compliance to vaccination

时间窗: 12 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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