Kidney transplant patients
Conditions
Sponsors
Hopital Erasme, Université Libre de Bruxelles
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age of 18 years old or older - Patients should met one of the cohort criteria - life expectancy > 12 months - Ability to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - women who are pregnant or breastfeeding. To reflect the real-world population of kidney transplant patients, the NEPHRO-VAC transplantation project is designed as inclusive as possible. Exclusion criteria are minimal and serve to exclude patients who are not evaluable, or in whom vaccination is considered not safe or not effective. Since baseline blood samples before vaccination will provide an individual reference level of antibody measures, potential bias can be anticipated for. As such, we can still evaluate the immune response induced by the vaccination only. Moreover, At baseline (ie before vaccination) blood samples will be taken. The existence of SARS-Cov-2 antibodies will be examined in the samples in retrospect. As such, based on the baseline antibody levels, we can divide the study population in a COVID+ and COVID- subgroup and perform subgroup analysis to evaluate the effect of this variable. We feel it is not feasible and necessary to exclude patients for the trial based on prevaccination SARS-CoV-2 antibody positivity. First of all the procedures in the study reflect the real life situation. Secondly, analyzing the study results the revaccination antibody levels will be a variable used in the analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In the year 2020, the COVID19 pandemic caused by the Sars-Cov2 virus was responsible for a high mortality rate particularly in solid organ transplant recipients, and especially in kidney transplant patients who are the most frequent among organ solid transplant patients. The recent availability of anti-Sars-Cov2 vaccines could protect them from severe disease. However, it is widely accepted that vaccine responses are much weaker in this populations compared to healthy controls. The primary objective is to assess the immune response to SARS-Cov2 vaccination (vaccine BNT162b2 Comirnaty®; Pfizer- BioNTech) in 80 kidney transplant recipients. Due to new SARS-CoV-2 variants and waning immunity, additional SARSCoV-2 vaccinations may be necessary. This amendment concerns the follow-up of the immune response, both in naïve and previously infected patients, after additional SARS-CoV-2 vaccinations done in the framework of the national vaccination program is highly relevant.;Secondary Objective: - to assess the safety of immunization by the vaccine BNT162b2 (Comirnaty®; Pfizer- BioNTech) after two doses - to study the duration of the immune response using serology assays performed on day 28 after the second dose as well as at 6 months after the first dose - to assess in depth the humoral and cellular responses to the vaccine BNT162b2 (Comirnaty®; Pfizer- BioNTech), by measuring the Sars-Cov2 specific T and B cell responses and its evolution and longevity by sampling blood at different time point - To compare the immunogenicity and safety of vaccination in patients previously infected or not by SARS-Cov2 - To assess the safety and efficacy of a third dose of vaccination by BNT162b2 (Comirnaty®; Pfizer- BioNTech) in COVID19 free patients - To assess the immune reponse to additional dose of anti-SARS-CoV2 vaccination - To assess the immune response to new variants in breakthrough cases;Primary end point(s): ELISA RBD antibodies (IgG) 28 days after booster dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety is accurately followed in kidney transplant patients receiving a vaccine through an autoquestionnary. Patients receive an individual planning for their study visits to the hospital among which also vaccination days are planned. Of course patients are planned to get a vaccine during a study consult on a day also other patients will receive their vaccine. A maximum of 24 patients will receive a vaccination per day. Next to the study nurse, also a doctor will be present for patient monitoring. After the consult, any adverse events, including redness at the injection site, will be followed continuously during each medical visit. It will be noticed each “Adverse event (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI)” and if there is a suspected relationship between AE and vaccin. Each suSAR will be reported in the SAE-form in the attached document. - ELISA RBD antibodies (IgG) 7 days after booster dose, titer of neutralizing antibodies 7 and 28 days after booster dose. Both total and neutralizing antibodies against SARS-Cov-2 will be assessed. The total amount of anti- SARS-Cov-2 IgG antibodies will be studied using an ELISA in which the binding capacities against SARS-CoV-2 spike protein – full S (S1 and S2) as well as against the receptor-binding domain of SARS-CoV-2 protein are tested. Furthermore, a multiplex immune assay will be used for simultaneously testing of the presence of different SARS-CoV-2 binding IgG antibodies. To measure the titers of neutralizing antibodies against SARS-Cov-2 spike protein and nucleocapsid protein, the capacity of the antibodies to neutralize an infection with SARSCoV-2 or pseudoviral particles in vitro will be tested. These methodologies are established and available at the laboratory of Sciensano. Both simple and multi parametric analyses will be performed. The aim is to have these answers within the first month after day 28 of the boost. - Additional endpoints: B-ce | — |
Countries
Belgium
Contacts
Public Contactdata manager
Hopital Erasme, Université Libre de Bruxelles
Outcome results
None listed