Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients (AMBU-VAX)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Chronic Kidney Disease; Chronic Disease; Inflammatory Bowel Disease; HIV Infection; Hematopoietic Stem Cell Transplantation; Solid Organ Transplantation; Asplenia; Frailty; Cancer; Immunocompromised; Autoimmune Diseases

Treatments: Biological: Hospital-Based Vaccination Pathway

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07391046

8272 (Other Identifier)

Details and patient eligibility

About

AMBU-VAX is a prospective, single-center observational study designed to develop and implement an organizational model for delivering recommended vaccinations within a hospital setting.

The study targets adult and elderly patients with chronic diseases or immunocompromising conditions who are eligible for vaccination according to national immunization guidelines. Vaccination is actively proposed during outpatient visits, hospital admissions, or at discharge and, when accepted, administered within the hospital or coordinated with local public health vaccination services.

The study aims to evaluate the feasibility, uptake, and completion of hospital-based vaccination pathways and to support integration between hospital and territorial prevention services for vulnerable populations.

Full description

Vaccination coverage among hospitalized and chronically ill patients remains suboptimal despite strong national and international recommendations. Hospital settings represent a strategic opportunity to identify vulnerable patients, reduce missed vaccination opportunities, and improve access to preventive services.

AMBU-VAX is a prospective observational study conducted at Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome. The study targets adult patients affected by chronic diseases or immunocompromising conditions eligible for recommended vaccinations according to the Italian National Immunization Plan 2023-2025.

Patients are identified during outpatient visits, hospital admissions, or at discharge. Vaccination is actively proposed and, when accepted, administered within the hospital vaccination clinic or ward. When appropriate, patients are referred to local vaccination services to complete their immunization schedule.

Primary outcomes include vaccination offer, vaccine uptake, number of administered doses, and completion of vaccination pathways within the hospital setting. Secondary outcomes include reasons for vaccine refusal and referral to territorial vaccination services.

The study aims to assess the feasibility, effectiveness, and sustainability of a hospital-based vaccination model that can be replicated in other healthcare settings.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged ≥18 years
• Presence of at least one chronic or immunocompromising condition eligible for vaccination according to national guidelines
• Written informed consent provided

Exclusion criteria

• Age <18 years
• Conditions not included among the predefined eligibility criteria