Chronic DiseaseAMBU-VAXNCT07391046
Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients
An observational study of Chronic Disease and Immunocompromised, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Immunocompromised, HIV Infection
- What is being tested?
- Hospital-Based Vaccination Pathway
- Type of treatment
- Vaccines
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults aged ≥18 years
- Presence of at least one chronic or immunocompromising condition eligible for vaccination according to national guidelines
- Written informed consent provided
Who cannot join
- Age <18 years
- Conditions not included among the predefined eligibility criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Patrizia Laurenti, Professor contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Disease, Immunocompromised, HIV Infection, Chronic Kidney Disease, Solid Organ Transplantation, Hematopoietic Stem Cell Transplantation
- Being tested
- Hospital-Based Vaccination Pathway
- Medical subject headings
- Chronic Disease, HIV Infections, Renal Insufficiency, Chronic, Neoplasms, Autoimmune Diseases, Inflammatory Bowel Diseases, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital-Based Vaccination PathwayBiological
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination Offer Rate
Proportion of patients evaluated by the vaccination service who are offered at least one recommended vaccination.
Measured: 12 months
Vaccination Uptake Rate
Proportion of patients who receive at least one vaccination among those evaluated.
Measured: 12 months
Number of Administered Vaccine Doses
Number of doses administered by vaccine type
Measured: 12 months
Completion of Hospital-Based Vaccination Pathway
Proportion of patients completing all scheduled vaccine doses within the hospital setting.
Measured: 12 months
Secondary outcomes (3)
Reasons for Vaccine Refusal
Distribution of reported reasons for refusal among patients offered vaccination.
Measured: 12 months
Referral to Territorial Vaccination Services
Proportion of patients referred to local public health vaccination services.
Measured: 12 months
Specialist Evaluation for Contraindications
Proportion of patients with contraindications who complete specialist evaluation and receive clearance for vaccination.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Patrizia Laurenti, Professor, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391046
- Sponsor's protocol ID
- 8272
- Acronym
- AMBU-VAX
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients: A Scalable and Sustainable Model
- ClinicalTrials.gov ID
- NCT07391046
- Acronym / sponsor ID
- AMBU-VAX / 8272
- Conditions
- Chronic Disease, Immunocompromised, HIV Infection, Chronic Kidney Disease, Solid Organ Transplantation, Hematopoietic Stem Cell Transplantation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adults aged ≥18 years
- Presence of at least one chronic or immunocompromising condition eligible for vaccination according to national guidelines
- Written informed consent provided
Key exclusion criteria (2 listed)
- Age <18 years
- Conditions not included among the predefined eligibility criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital-Based Vaccination PathwayIntegration 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. | Biological | – |
Primary outcome
Vaccination Offer Rate
Time frame: 12 months
Proportion of patients evaluated by the vaccination service who are offered at least one recommended vaccination.
Vaccination Uptake Rate
Time frame: 12 months
Proportion of patients who receive at least one vaccination among those evaluated.
Number of Administered Vaccine Doses
Time frame: 12 months
Number of doses administered by vaccine type
Completion of Hospital-Based Vaccination Pathway
Time frame: 12 months
Proportion of patients completing all scheduled vaccine doses within the hospital setting.
3 secondary outcomes
Reasons for Vaccine Refusal
Time frame: 12 months
Referral to Territorial Vaccination Services
Time frame: 12 months
Specialist Evaluation for Contraindications
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrizia Laurenti, Professor contact
Patrizia Laurenti, Professor principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease and Immunocompromised, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrizia Laurenti, Professor (063015.9333, patrizia.laurenti@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination Offer Rate (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.