ImmunosuppressionREVAPINCT06463119
Registry of Vaccine Responses in Immune Compromised Patients
An observational study of Immunosuppression, run by Laure Pittet, MD-PhD at 1 site in Switzerland.
Trial summary
The aim of this project is to monitor, guide and document vaccination, vaccine responses, persistence of protection, vaccine efficacy and safety in immune compromised patients at various moment of their disease: right after the diagnosis, before the introduction of the immunosuppressive treatment, once the individual… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Immunosuppression
- What is being tested?
- Collection of data in a registry
- Type of treatment
- Vaccines
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Sep 2024to Apr 2029
- How long will I take part?
- 5 Years
- 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
- Child, Adult, Older adult
Study population: Priority will be given to patients with the following disease compromising their immune system: * Solid organ recipients * Hematopoietic stem cell transplant recipients * HIV * Dysimmune disorders * Inflammatory bowel disease * Rheumatologic disease * Neuro-immunological disease * Nephrotic syndrome * Primary immunodeficiency disorder * Pneumological disease requiring immunosuppression (e.g. bronchiolitis obliterans) * Oncological disease
Who may be able to join
- Immune compromised patient or patient who will soon be immunocompromised
- Informed consent as documented by signature
Who cannot join
- Individual/parental inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, known/suspected non-compliance, substance abuse, etc.
- Plan to move out of the country or have prolong absence in the next 2 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospitals of Geneva
Geneva, 1211
Laure F Pittet, MD-PhD, 0795538277, laure.pittet@hug.ch
Laure F Pittet, MD-PhD
About this study
The aim of this project is to monitor, guide and document vaccination, vaccine responses, persistence of protection, vaccine efficacy and safety in immune compromised patients at various moment of their disease: right after the diagnosis, before the introduction of the immunosuppressive treatment, once the individual is under immunosuppressive treatment, or once immunosuppression is over.
Read the detailed description
The aim of this project is to monitor, guide and document vaccination, vaccine responses, persistence of protection, vaccine efficacy and safety in immune compromised patients at various moment of their disease: right after the diagnosis, before the introduction of the immunosuppressive treatment, once the individual is under immunosuppressive treatment, or once immunosuppression is over. The project will not only help to optimise the vaccination status of the immunocompromised patients followed in our institution, but will enable to gather essential data on vaccine responses and the evolution of serology against vaccine-preventable diseases over time. The project will also collect essential data on vaccination with live-attenuated vaccines.
The University Hospitals of Geneva and the Centre of vaccinology of the University of Geneva are recognised worldwide for their expertise in vaccinology, particularly in immunocompromised patients. Unfortunately, the management of these patients is not yet standardised, and no data is collected, precluding its dissemination. The aim of this project is to enable to share our expertise on vaccination of immune compromised patients with other teams by standardizing our practice and creating a registry.
Although measles-mumps-rubella (MMR) and varicella-zoster virus (VZV) vaccination are recommended in selected immune compromised patients fulfilling strict safety criterion, these criteria are not standardised, and only few groups have reported on the immunogenicity and the safety of these vaccination. As a results, many healthcare providers are hesitant to administer the vaccines and call for standardized operating procedures for vaccination and follow-up that are adapted to each immunocompromised condition. In addition, there are no data on the patients' perceptions of these vaccinations.
Therefore, the objective of this project is to optimise the administration of vaccines to immunocompromised patients by providing tailored information and personalised follow-up. The project will evaluate what information the patients need before and after vaccination, and what kind of follow-up is the most appropriate for each condition. By providing a standardised clinical and serological follow-up, this project will also document the reactogenicity and the immunogenicity of vaccines, and identify whether they differ among the various immune compromised state. It will also identify in whom and for which vaccines, additional doses are required to reach protection, and in whom repeated doses are needed during follow-up to maintain protection throughout the years. The results of this project will help to improve the follow-up of immune compromised patients following vaccination, and provide tailored follow-up for each of the immune compromised condition.
- Conditions
- Immunosuppression
- Being tested
- Collection of data in a registry
- Keywords
- Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of data in a registryOther
The aim of this observational project is to document the immunogenicity and reactogenicity of vaccines given to immunocompromised patients and collect it in a registry.
| Study group | Role | What they receive |
|---|---|---|
| Immunocompromised patients | Priority will be given to patients with the following disease compromising their immune system:
* Solid organ recipients
* Hematopoietic stem cell transplant recipients
* HIV
* Dysimmune disorders
* Inflammatory bowel disease
* Rheumatologic disease
* Neuro-immunological disease
* Nephrotic syndrome
* Primary immunodeficiency disorder
* Pneumological disease requiring immunosuppression (e.g. bronchiolitis obliterans)
* Oncological disease Receives: Other: Collection of data in a registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dose of vaccine required to reach seroprotection
Number of doses of vaccines required to reach seroprotection, described by vaccine type and immunocompromised state
Measured: 2 months (window allowed: 1 to 3 months) after vaccination
Secondary outcomes (5)
Number of dose of vaccine required to maintain seroprotection
Number of doses of vaccines required to reach seroprotection, described by vaccine type and immunocompromised state
Measured: 5 years follow-up
Immunogenicity of vaccine (vaccine responses) in immune compromised patients
Vaccine-induced seroprotection (defined as vaccine-specific immunoglobulin concentration above seroprotection cut-off) measured in the 1 to 3 months following vaccination. If funding is sufficient, vaccine-induced cellular response and memory cells will be quantified in a subgroup of participants. Correlation with clinical protection will be evaluated as well.
Measured: 2 months (window allowed: 1 to 3 months) after vaccination
Persistence of vaccine-induced seroprotection in immune compromised patients
Persistence of vaccine-induced seroprotection (defined as vaccine-specific immunoglobulin concentration above seroprotection cut-off) measured more than 9 months after vaccination. There may be multiple measures per patients, as these are monitored regularly in immune compromised patients. If funding is sufficient, vaccine-induced functional antibodies, cellular responses and memory cells will be quantified in a subgroup of participants. Correlation with clinical protection will be evaluated as well.
Measured: 5 years follow-up
Occurence of adverse event following vaccine administration in immune compromised patients
Occurrence and severity of local and systemic reaction measured from day 0 to day 42 after vaccination
Measured: 0 to 42 days after vaccination
Patients' acceptability of the standardized follow-up
Evaluated through satisfaction questionnaire with open questions, qualitative research
Measured: 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start24 Sep 2024
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Laure Pittet, MD-PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laure Pittet, MD-PhD, Pediatric Clinical Research Platform
- Investigators
- Laure F Pittet, MD-PhD, Principal investigator, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463119
- Sponsor's protocol ID
- CCER 2024-00363
- Acronym
- REVAPI
- Status last verified
- Nov 2024
- First submitted
- 27 May 2024
- Last updated
- 7 Nov 2024
- 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 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Vaccine Responses in Immune Compromised Patients
- ClinicalTrials.gov ID
- NCT06463119
- Acronym / sponsor ID
- REVAPI / CCER 2024-00363
- Conditions
- Immunosuppression
- Keywords
- Vaccine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Laure Pittet, MD-PhDUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 17 Jun 2024 (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.
The aim of this project is to monitor, guide and document vaccination, vaccine responses, persistence of protection, vaccine efficacy and safety in immune compromised patients at various moment of their disease: right after the diagnosis, before the introduction of the immunosuppressive treatment, once the individual is under immunosuppressive treatment, or once immunosuppression is over.
Detailed description
The aim of this project is to monitor, guide and document vaccination, vaccine responses, persistence of protection, vaccine efficacy and safety in immune compromised patients at various moment of their disease: right after the diagnosis, before the introduction of the immunosuppressive treatment, once the individual is under immunosuppressive treatment, or once immunosuppression is over. The project will not only help to optimise the vaccination status of the immunocompromised patients followed in our institution, but will enable to gather essential data on vaccine responses and the evolution of serology against vaccine-preventable diseases over time. The project will also collect essential data on vaccination with live-attenuated vaccines.
The University Hospitals of Geneva and the Centre of vaccinology of the University of Geneva are recognised worldwide for their expertise in vaccinology, particularly in immunocompromised patients. Unfortunately, the management of these patients is not yet standardised, and no data is collected, precluding its dissemination. The aim of this project is to enable to share our expertise on vaccination of immune compromised patients with other teams by standardizing our practice and creating a registry.
Although measles-mumps-rubella (MMR) and varicella-zoster virus (VZV) vaccination are recommended in selected immune compromised patients fulfilling strict safety criterion, these criteria are not standardised, and only few groups have reported on the immunogenicity and the safety of these vaccination. As a results, many healthcare providers are hesitant to administer the vaccines and call for standardized operating procedures for vaccination and follow-up that are adapted to each immunocompromised condition. In addition, there are no data on the patients' perceptions of these vaccinations.
Therefore, the objective of this project is to optimise the administration of vaccines to immunocompromised patients by providing tailored information and personalised follow-up. The project will evaluate what information the patients need before and after vaccination, and what kind of follow-up is the most appropriate for each condition. By providing a standardised clinical and serological follow-up, this project will also document the reactogenicity and the immunogenicity of vaccines, and identify whether they differ among the various immune compromised state. It will also identify in whom and for which vaccines, additional doses are required to reach protection, and in whom repeated doses are needed during follow-up to maintain protection throughout the years. The results of this project will help to improve the follow-up of immune compromised patients following vaccination, and provide tailored follow-up for each of the immune compromised condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunocompromised patients | – | Other: Collection of data in a registryPriority will be given to patients with the following disease compromising their immune system: * Solid organ recipients * Hematopoietic stem cell transplant recipients * HIV * Dysimmune disorders * Inflammatory bowel disease * Rheumatologic disease * Neuro-immunological disease * Nephrotic syndrome * Primary immunodeficiency disorder * Pneumological disease requiring immunosuppression (e.g. bronchiolitis obliterans) * Oncological disease |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Priority will be given to patients with the following disease compromising their immune system: * Solid organ recipients * Hematopoietic stem cell transplant recipients * HIV * Dysimmune disorders * Inflammatory bowel disease * Rheumatologic disease * Neuro-immunological disease * Nephrotic syndrome * Primary immunodeficiency disorder * Pneumological disease requiring immunosuppression (e.g. bronchiolitis obliterans) * Oncological disease
Key inclusion criteria (2 listed)
- Immune compromised patient or patient who will soon be immunocompromised
- Informed consent as documented by signature
Key exclusion criteria (2 listed)
- Individual/parental inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, known/suspected non-compliance, substance abuse, etc.
- Plan to move out of the country or have prolong absence in the next 2 months
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 |
|---|---|---|
| Collection of data in a registryThe aim of this observational project is to document the immunogenicity and reactogenicity of vaccines given to immunocompromised patients and collect it in a registry. | Other | Immunocompromised patients |
Primary outcome
Number of dose of vaccine required to reach seroprotection
Time frame: 2 months (window allowed: 1 to 3 months) after vaccination
Number of doses of vaccines required to reach seroprotection, described by vaccine type and immunocompromised state
5 secondary outcomes
Number of dose of vaccine required to maintain seroprotection
Time frame: 5 years follow-up
Immunogenicity of vaccine (vaccine responses) in immune compromised patients
Time frame: 2 months (window allowed: 1 to 3 months) after vaccination
Persistence of vaccine-induced seroprotection in immune compromised patients
Time frame: 5 years follow-up
Occurence of adverse event following vaccine administration in immune compromised patients
Time frame: 0 to 42 days after vaccination
Patients' acceptability of the standardized follow-up
Time frame: 5 years follow-up
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 7 Nov 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Immunosuppression
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
Active, not recruitingPhase 1
CD4^LVFOXP3 in Participants With IPEX
IPEX
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.
Laure F Pittet, MD-PhD principal investigator
University Hospitals of Geneva
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 Immunosuppression, run by Laure Pittet, MD-PhD at 1 site in Switzerland.
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 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: looking for participants now, as of the sponsor's last update on 7 Nov 2024. 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 Switzerland. 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 Laure F Pittet, MD-PhD (0223725481, laure.pittet@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dose of vaccine required to reach seroprotection (time frame: 2 months (window allowed: 1 to 3 months) after vaccination). 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 7 Nov 2024.