Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients

NCT07391046 | Not Yet Recruiting

• 1 other identifier: 8272
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Vaccination Offer Rate

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

  12 months

• Vaccination Uptake Rate

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

  12 months

• Number of Administered Vaccine Doses

  Number of doses administered by vaccine type

  12 months

• Completion of Hospital-Based Vaccination Pathway

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

  12 months

Secondary Outcomes (3)

• Reasons for Vaccine Refusal

  12 months

• Referral to Territorial Vaccination Services

  12 months

• Specialist Evaluation for Contraindications

  12 months

Interventions

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.

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

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Pfizer: collaborator

MeSH Terms

Conditions

Chronic Disease; HIV Infections; Renal Insufficiency, Chronic; Neoplasms; Autoimmune Diseases; Inflammatory Bowel Diseases; Frailty

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Patrizia Laurenti, Professor

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrizia Laurenti, Professor

CONTACT

063015.9333; patrizia.laurenti@policlinicogemelli.it

Patrizia Laurenti, Professor

CONTACT

Study Design

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

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01