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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for Vaccine Refusal | Distribution of reported reasons for refusal among patients offered vaccination. | 12 months |
| Referral to Territorial Vaccination Services | Proportion of patients referred to local public health vaccination services. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrizia Laurenti, Professor | Contact | 063015.9333 | patrizia.laurenti@policlinicogemelli.it | |
| Patrizia Laurenti, Professor | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Patrizia Laurenti, Professor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
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| 12 months |
| Specialist Evaluation for Contraindications | Proportion of patients with contraindications who complete specialist evaluation and receive clearance for vaccination. | 12 months |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D015658 | HIV Infections |
| D051436 | Renal Insufficiency, Chronic |
| D009369 | Neoplasms |
| D001327 | Autoimmune Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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