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NCT Number: NCT07391046

Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients

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.

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Key information

Conditions

Chronic Disease Asplenia Autoimmune Diseases Blood-Borne Infections Cancer Chronic Kidney Disease Communicable Diseases Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Frailty Gastroenteritis Gastrointestinal Diseases Genital Diseases HIV Infection HIV Infections Hematopoietic Stem Cell Transplantation Immune System Diseases Immunocompromised Immunologic Deficiency Syndromes Infections Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases Kidney Diseases Lentivirus Infections Male Urogenital Diseases Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Solid Organ Transplantation Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hospital-Based Vaccination Pathway

Biological

Integration of vaccination counseling, prescription, and administration into hospital care pathways for vulnerable adult patients, including coordination with local public health vaccination services. No experimental vaccine is used; all vaccines are administered according to national guidelines.

Primary outcomes

  1. Vaccination Offer Rate

    Time frame: 12 months

    Proportion of patients evaluated by the vaccination service who are offered at least one recommended vaccination.

  2. Vaccination Uptake Rate

    Time frame: 12 months

    Proportion of patients who receive at least one vaccination among those evaluated.

  3. Number of Administered Vaccine Doses

    Time frame: 12 months

    Number of doses administered by vaccine type

  4. Completion of Hospital-Based Vaccination Pathway

    Time frame: 12 months

    Proportion of patients completing all scheduled vaccine doses within the hospital setting.

Secondary outcomes

  1. Reasons for Vaccine Refusal

    Time frame: 12 months

    Distribution of reported reasons for refusal among patients offered vaccination.

  2. Referral to Territorial Vaccination Services

    Time frame: 12 months

    Proportion of patients referred to local public health vaccination services.

  3. Specialist Evaluation for Contraindications

    Time frame: 12 months

    Proportion of patients with contraindications who complete specialist evaluation and receive clearance for vaccination.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrizia Laurenti, Professor

CONTACT

[email protected]

063015.9333

Patrizia Laurenti, Professor

CONTACT

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: AMBU-VAX

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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