Vaccine ProphylaxisNCT07473999
Factors Affecting Vaccine Prophylaxis Efficacy in Bone Marrow and Solid Organ Transplant Recipients: Impact on Infection and Mortality Rates
An observational study of Vaccine Prophylaxis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Transplantation is one of the most challenging and complex areas of modern medicine. Besides the intrinsic complexity of the surgical and medical procedures, transplantation medicine must take into account a flawless medical management before and after transplant, especially because these patients represent a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vaccine Prophylaxis
- What is being tested?
- vaccine prophylaxis
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 13 Sep 2019to 13 Sep 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: BMT patients and SOT patients
Who may be able to join
- Any patient eligible for SOT or BMT evaluated in our hospital
- Only patients undergoing SOT or BMT will be followed-up for infections
Who cannot join
- Already enrolled in the study
- Denied informed consent
- Absolute contraindication to vaccinations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100
Alba Muzzi, MD, 0382502268, a.muzzi@smatteo.pv.it
Muzzi
About this study
Transplantation is one of the most challenging and complex areas of modern medicine. Besides the intrinsic complexity of the surgical and medical procedures, transplantation medicine must take into account a flawless medical management before and after transplant, especially because these patients represent a high-risk group for developing infectious complications that may be vaccine-preventable, with a high mortality rate. However, there is poor evidence regarding the effectiveness of the currently available vaccines in immunocompromised patients. The aim of this study, is the development of a specific healthcare pathway for the prevention of infectious diseases for patients referred to our Hospital who are eligible for solid organ transplantation (SOT) or bone marrow transplantation (BMT), thus improving the vaccination coverage of these patients, possibly reducing infection-related mortality. All patients who will undergo SOT or BMT will be enrolled in the study. As per clinical practice, all these patients will be asked to receive currently recommended vaccinations. Prior to vaccination, there will be the assessment and characterization of B- and T-cell immune functions, in order to verify whether the immune system is able to respond to vaccines stimulation. Also, there will be the assessment of overall splenic function, through counting pitted red cells, the record of the incidence of infectious diseases for the subsequent 5 years after enrollment and the record of all episodes of transplant rejection. Finally, all adverse events and causes of non-adherence to the planned vaccination schedule will be recorded. All physicians involved in the care of these patients will receive a specific educational kit, including recommended vaccinations and booster doses. As a part of the project, physicians will also be offered an in-hospital education program, including lectures about the importance of vaccine prophylaxis.
- Conditions
- Vaccine Prophylaxis
- Being tested
- vaccine prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccine prophylaxisBiological
evaluation of safety and effectiveness of vaccines in immunocompromised patients, in terms of prevention of infections
| Study group | Role | What they receive |
|---|---|---|
| vaccinated and immunocompromised patients | group of cases Receives: Biological: vaccine prophylaxis | |
| non vaccinated immunocompromised patients | group of controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of infections and mortality rate from vaccine-preventable infectious diseases
To explore the incidence of infections and mortality rate from vaccine-preventable infectious diseases (S. pneumoniae, N. meningitidis, influenza, along with their serotype, SARS-CoV-2) in the 5 years of observation, in vaccinated patients. A sample of unvaccinated patients will be used as control.
Measured: up to 7 years
Secondary outcomes (2)
vaccinations-related adverse events
Measured: up to 7 years
vaccine immunocompetence
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start13 Sep 2019
- Primary completion13 Sep 2026 (estimated)
- Study completion13 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ProphylaxisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alba Muzzi, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473999
- Sponsor's protocol ID
- TRISMA
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Vaccine Prophylaxis Efficacy in Bone Marrow and Solid Organ Transplant Recipients: Impact on Infection and Mortality Rates
- ClinicalTrials.gov ID
- NCT07473999
- Acronym / sponsor ID
- TRISMA
- Conditions
- Vaccine Prophylaxis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 13 Sep 2026 (estimated)
- Study completion
- 13 Sep 2026 (estimated)
- First posted
- 16 Mar 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.
Transplantation is one of the most challenging and complex areas of modern medicine. Besides the intrinsic complexity of the surgical and medical procedures, transplantation medicine must take into account a flawless medical management before and after transplant, especially because these patients represent a high-risk group for developing infectious complications that may be vaccine-preventable, with a high mortality rate. However, there is poor evidence regarding the effectiveness of the currently available vaccines in immunocompromised patients. The aim of this study, is the development of a specific healthcare pathway for the prevention of infectious diseases for patients referred to our Hospital who are eligible for solid organ transplantation (SOT) or bone marrow transplantation (BMT), thus improving the vaccination coverage of these patients, possibly reducing infection-related mortality. All patients who will undergo SOT or BMT will be enrolled in the study. As per clinical practice, all these patients will be asked to receive currently recommended vaccinations. Prior to vaccination, there will be the assessment and characterization of B- and T-cell immune functions, in order to verify whether the immune system is able to respond to vaccines stimulation. Also, there will be the assessment of overall splenic function, through counting pitted red cells, the record of the incidence of infectious diseases for the subsequent 5 years after enrollment and the record of all episodes of transplant rejection. Finally, all adverse events and causes of non-adherence to the planned vaccination schedule will be recorded. All physicians involved in the care of these patients will receive a specific educational kit, including recommended vaccinations and booster doses. As a part of the project, physicians will also be offered an in-hospital education program, including lectures about the importance of vaccine prophylaxis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaccinated and immunocompromised patients | – | Biological: vaccine prophylaxisgroup of cases |
| non vaccinated immunocompromised patients | – | –group of controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- BMT patients and SOT patients
Key inclusion criteria (2 listed)
- Any patient eligible for SOT or BMT evaluated in our hospital
- Only patients undergoing SOT or BMT will be followed-up for infections
Key exclusion criteria (3 listed)
- Already enrolled in the study
- Denied informed consent
- Absolute contraindication to vaccinations
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 |
|---|---|---|
| vaccine prophylaxisevaluation of safety and effectiveness of vaccines in immunocompromised patients, in terms of prevention of infections | Biological | vaccinated and immunocompromised patients |
Primary outcome
incidence of infections and mortality rate from vaccine-preventable infectious diseases
Time frame: up to 7 years
To explore the incidence of infections and mortality rate from vaccine-preventable infectious diseases (S. pneumoniae, N. meningitidis, influenza, along with their serotype, SARS-CoV-2) in the 5 years of observation, in vaccinated patients. A sample of unvaccinated patients will be used as control.
2 secondary outcomes
vaccinations-related adverse events
Time frame: up to 7 years
vaccine immunocompetence
Time frame: up to 7 years
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 16 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Prophylaxis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Alba Muzzi (0382/502268, a.muzzi@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of infections and mortality rate from vaccine-preventable infectious diseases (time frame: up to 7 years). 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 16 Mar 2026.