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

January 29, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients: A Scalable and Sustainable Model

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Patrizia Laurenti, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes adult patients (≥18 years) with chronic diseases or immunocompromising conditions who are eligible for recommended vaccinations according to the Italian National Immunization Plan 2023-2025.

Patients are identified during outpatient visits, hospital admissions, or at discharge from the Fondazione Policlinico Universitario "A. Gemelli" IRCCS. The population includes both male and female patients and reflects a broad spectrum of chronic and immunocompromising conditions, including cancer, solid organ transplantation, hematopoietic stem cell transplantation, autoimmune diseases, chronic kidney disease, HIV infection, asplenia, and frailty.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccination Offer Rate
Time Frame: 12 months
Proportion of patients evaluated by the vaccination service who are offered at least one recommended vaccination.
12 months
Vaccination Uptake Rate
Time Frame: 12 months
Proportion of patients who receive at least one vaccination among those evaluated.
12 months
Number of Administered Vaccine Doses
Time Frame: 12 months
Number of doses administered by vaccine type
12 months
Completion of Hospital-Based Vaccination Pathway
Time Frame: 12 months
Proportion of patients completing all scheduled vaccine doses within the hospital setting.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons for Vaccine Refusal
Time Frame: 12 months
Distribution of reported reasons for refusal among patients offered vaccination.
12 months
Referral to Territorial Vaccination Services
Time Frame: 12 months
Proportion of patients referred to local public health vaccination services.
12 months
Specialist Evaluation for Contraindications
Time Frame: 12 months
Proportion of patients with contraindications who complete specialist evaluation and receive clearance for vaccination.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Pfizer

Investigators

  • Principal Investigator: Patrizia Laurenti, Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8272 (CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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