Registry of Vaccine Responses in Immune Compromised Patients
ConditionImmunosuppression
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLaure Pittet, MD-PhD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Immune compromised patient or patient who will soon be immunocompromised
Informed consent as documented by signature
Disqualifiers
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 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Collection of data in a registry
Other interventionThe aim of this observational project is to document the immunogenicity and reactogenicity of vaccines given to immunocompromised patients and collect it in a registry.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Immunocompromised patients1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
2 months (window allowed: 1 to 3 months) after vaccinationSecondary outcomes
1
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
Time frame
5 years follow-up2
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.
Time frame
2 months (window allowed: 1 to 3 months) after vaccination3
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.
Time frame
5 years follow-up4
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
Time frame
0 to 42 days after vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Laure Pittet, MD-PhD
Lead sponsor
Pediatric Clinical Research Platform
Sponsor institution
Source ClinicalTrials.gov